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    Chemistry

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    Also known as: 53-03-2, Dehydrocortisone, Decortin, Deltasone, Meticorten, Orasone
    Molecular Formula
    C21H26O5
    Molecular Weight
    358.4  g/mol
    InChI Key
    XOFYZVNMUHMLCC-ZPOLXVRWSA-N
    FDA UNII
    VB0R961HZT
    Prednisone
    A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
    Prednisone is a Corticosteroid. The mechanism of action of prednisone is as a Corticosteroid Hormone Receptor Agonist.
    1 2D Structure

    Prednisone

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (8S,9S,10R,13S,14S,17R)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,12,14,15,16-octahydrocyclopenta[a]phenanthrene-3,11-dione
    2.1.2 InChI
    InChI=1S/C21H26O5/c1-19-7-5-13(23)9-12(19)3-4-14-15-6-8-21(26,17(25)11-22)20(15,2)10-16(24)18(14)19/h5,7,9,14-15,18,22,26H,3-4,6,8,10-11H2,1-2H3/t14-,15-,18+,19-,20-,21-/m0/s1
    2.1.3 InChI Key
    XOFYZVNMUHMLCC-ZPOLXVRWSA-N
    2.1.4 Canonical SMILES
    CC12CC(=O)C3C(C1CCC2(C(=O)CO)O)CCC4=CC(=O)C=CC34C
    2.1.5 Isomeric SMILES
    C[C@]12CC(=O)[C@H]3[C@H]([C@@H]1CC[C@@]2(C(=O)CO)O)CCC4=CC(=O)C=C[C@]34C
    2.2 Other Identifiers
    2.2.1 UNII
    VB0R961HZT
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acsis, Prednison

    2. Apo-prednisone

    3. Cortan

    4. Cortancyl

    5. Cutason

    6. Dacortin

    7. Decortin

    8. Decortisyl

    9. Dehydrocortisone

    10. Delta-cortisone

    11. Deltasone

    12. Encorton

    13. Encortone

    14. Enkortolon

    15. Kortancyl

    16. Liquid Pred

    17. Meticorten

    18. Orasone

    19. Panafcort

    20. Panasol

    21. Predni Tablinen

    22. Prednidib

    23. Predniment

    24. Prednison Acsis

    25. Prednison Galen

    26. Prednison Hexal

    27. Pronisone

    28. Rectodelt

    29. Sone

    30. Sterapred

    31. Ultracorten

    32. Winpred

    2.3.2 Depositor-Supplied Synonyms

    1. 53-03-2

    2. Dehydrocortisone

    3. Decortin

    4. Deltasone

    5. Meticorten

    6. Orasone

    7. Supercortil

    8. Metacortandracin

    9. Decortisyl

    10. Rectodelt

    11. Sterapred

    12. Ultracorten

    13. Dacortin

    14. Encorton

    15. Paracort

    16. Cortan

    17. 1,2-dehydrocortisone

    18. Liquid Pred

    19. Deltacortisone

    20. Deltacortone

    21. Ancortone

    22. Colisone

    23. Decortancyl

    24. Deltison

    25. Encortone

    26. Prednilonga

    27. Prednison

    28. Servisone

    29. Lodotra

    30. Prednicen-m

    31. Delta-dome

    32. Di-adreson

    33. Bicortone

    34. Cortidelt

    35. Dekortin

    36. Diadreson

    37. Enkorton

    38. Hostacortin

    39. Lisacort

    40. Panafcort

    41. Prednisonum

    42. Prednizon

    43. Pronison

    44. Ultracortene

    45. Zenadrid

    46. Adasone

    47. Cotone

    48. Deltra

    49. Juvason

    50. Nurison

    51. Winpred

    52. Wojtab

    53. Prednisone Intensol

    54. Delta-cortelan

    55. 17,21-dihydroxypregna-1,4-diene-3,11,20-trione

    56. Delta E

    57. In-sone

    58. Cartancyl

    59. Deltisona

    60. Sk-prednisone

    61. Prednisona

    62. Prednisonum [inn-latin]

    63. Prednisona [inn-spanish]

    64. 1,4-pregnadiene-17alpha,21-diol-3,11,20-trione

    65. Pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-

    66. Prednisone Anhydrous

    67. Deltisone

    68. Rayos

    69. Zenadrid (veterinary)

    70. Fernisone

    71. Prednisone Tablets

    72. 1-dehydrocortisone

    73. 3en3hg4wsw

    74. Nsc-10023

    75. Nci-c04897

    76. Nsc 10023

    77. U 6020

    78. Prednidib

    79. Chebi:8382

    80. Panasol

    81. Delta-cortisone

    82. Sone

    83. Zenadrid [veterinary]

    84. Apo-prednisone

    85. Novoprednisone

    86. Dellacort

    87. Deltacortene

    88. Econosone

    89. Incocortyl

    90. Parmenison

    91. Predeltin

    92. Prednicorm

    93. Prednicort

    94. Prednicot

    95. Prednitone

    96. Prednovister

    97. Retrocortine

    98. Dacorten

    99. Fiasone

    100. Pehacort

    101. Presone

    102. Delta Cortelan

    103. Nisona

    104. Nizon

    105. Dellacort A

    106. Vb0r961hzt

    107. Me-korti

    108. Origen Prednisone

    109. (8s,9s,10r,13s,14s,17r)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,12,14,15,16-octahydrocyclopenta[a]phenanthrene-3,11-dione

    110. .delta.-cortisone

    111. 1-cortisone

    112. .delta.1-cortisone

    113. Delta-1-cortisone

    114. Ncgc00090766-01

    115. Precort

    116. .delta.1-dehydrocortisone

    117. Dsstox_cid_1185

    118. Meticorten (veterinary)

    119. Delta(sup 1)-cortisone

    120. Delta-1-dehydrocortisone

    121. Dsstox_rid_75997

    122. Dsstox_gsid_21185

    123. (8s,9s,10r,13s,14s,17r)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,10,12,13,14,15,16,17-decahydro-3h-cyclopenta[a]phenanthrene-3,11(6h)-dione

    124. Delta(sup 1)-dehydrocortisone

    125. Lodtra

    126. Smr000718760

    127. Smr001227202

    128. Delta E.

    129. Ccris 2646

    130. Hsdb 3168

    131. Mls002638114

    132. Einecs 200-160-3

    133. Mfcd00003608

    134. Unii-vb0r961hzt

    135. Prednisone [usp:inn:ban]

    136. 1,4-pregnadiene-17-alpha,21-diol-3,11,20-trione

    137. Ai3-52939

    138. .delta.sone

    139. .delta.-cortone

    140. .delta.-cortelan

    141. Cas-53-03-2

    142. Deltadehydrocortisone

    143. Prednisone(adasone)

    144. Prestwick_405

    145. .delta. E

    146. .delta.-e

    147. Prednisone (adasone)

    148. Prednisone, >=98%

    149. Prednisone [mi]

    150. Prednisone [inn]

    151. Prestwick0_000077

    152. Prestwick1_000077

    153. Prestwick2_000077

    154. Prestwick3_000077

    155. Prednisone [hsdb]

    156. Prednisone [iarc]

    157. .delta.(sup1)-cortisone

    158. P1276

    159. Modified-release Prednisone

    160. Prednisone [vandf]

    161. Chembl635

    162. Prednisone [mart.]

    163. Schembl3288

    164. Prednisone [usp-rs]

    165. Prednisone [who-dd]

    166. Bspbio_000293

    167. Mls001061265

    168. Mls001304073

    169. Mls001335907

    170. Mls001335908

    171. Mls002154191

    172. Mls002207083

    173. Mls002548880

    174. Spbio_002214

    175. Bpbio1_000323

    176. Gtpl7096

    177. Megxm0_000443

    178. Prednisone [green Book]

    179. Dtxsid4021185

    180. Prednisone [orange Book]

    181. Acon0_000082

    182. Acon1_000297

    183. Prednisone [ep Monograph]

    184. Hms1568o15

    185. Hms2090j13

    186. Hms2095o15

    187. Hms2231i24

    188. Hms3039k07

    189. Hms3259i09

    190. Hms3712o15

    191. Hms3884c04

    192. Prednisone [usp Monograph]

    193. 1,21-diol-3,11,20-trione

    194. Bcp09049

    195. Hy-b0214

    196. Nsc10023

    197. Prednisone Tablets [usp-rs]

    198. Pregna-1,4-diene-3,11,20-trione Monohydrate, 17,21-dihydroxy-

    199. Zinc3875357

    200. Tox21_111014

    201. Tox21_201564

    202. Tox21_300196

    203. Bdbm50550126

    204. Lmst02030180

    205. S1622

    206. Akos005267096

    207. Akos007930684

    208. Prednisone 100 Microg/ml In Methanol

    209. Tox21_111014_1

    210. Ccg-220077

    211. Db00635

    212. Nc00475

    213. Ncgc00090766-02

    214. Ncgc00090766-03

    215. Ncgc00090766-04

    216. Ncgc00090766-05

    217. Ncgc00090766-07

    218. Ncgc00254096-01

    219. Ncgc00259113-01

    220. Prednisone, Tested According To Ph.eur.

    221. Ac-11112

    222. As-11685

    223. Nci60_000008

    224. Prednisone 100 Microg/ml In Acetonitrile

    225. Prednisolone Impurity B [ep Impurity]

    226. Pregna-1,11,20-trione, 17,21-hydroxy-

    227. En300-52605

    228. Pregna-1,11,20-trione, 17,21-dihydroxy-

    229. C07370

    230. 003p608

    231. Q424972

    232. Sr-01000837536

    233. Sr-01000837536-3

    234. Brd-k85883481-001-04-2

    235. Brd-k85883481-001-08-3

    236. Brd-k85883481-001-25-7

    237. 17alpha,21-dihydroxypregna-1,4-diene-3,11,20-trione

    238. Wln: L E5 B666 Cv Ov Ahttt&j A1 E1 Fv1q Fq

    239. Prednisone, British Pharmacopoeia (bp) Reference Standard

    240. Prednisone, European Pharmacopoeia (ep) Reference Standard

    241. Prednisone, United States Pharmacopeia (usp) Reference Standard

    242. Prednisone, Pharmaceutical Secondary Standard; Certified Reference Material

    243. Prednisone For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    244. Prednisone, Pharmaceutical Secondary Standard; Traceable To Usp, Pheur And Bp

    245. (8s,10r,13s,17r)-17-hydroxy-17-(2-hydroxy-acetyl)-10,13-dimethyl-7,8,9,10,12,13,14,15,16,17-decahydro-6h-cyclopenta[a]phenanthrene-3,11-dione

    246. Prednisone Solution, 100 Mug/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 358.4 g/mol
    Molecular Formula C21H26O5
    XLogP31.5
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass358.17802393 g/mol
    Monoisotopic Mass358.17802393 g/mol
    Topological Polar Surface Area91.7 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity764
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NamePrednisone
    PubMed HealthPrednisone (By mouth)
    Drug ClassesEndocrine-Metabolic Agent, Immune Suppreant
    Drug LabelEach tablet for oral administration contains:Prednisone.............................................................1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mgEach 5 mL of oral solution for oral administration contains:Prednisone........................
    Active IngredientPrednisone
    Dosage FormTablet; Solution
    RouteOral
    Strength2.5mg; 1mg; 5mg; 50mg; 10mg; 5mg/5ml; 20mg
    Market StatusPrescription
    CompanyVintage Pharms; Jubilant Cadista; Hikma Pharms; Roxane; Watson Labs; Mutual Pharm; Contract Pharmacal

    2 of 6  
    Drug NamePrednisone intensol
    PubMed HealthPrednisone (By mouth)
    Drug ClassesEndocrine-Metabolic Agent, Immune Suppreant
    Drug LabelEach tablet for oral administration contains: Prednisone.....................................................1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mgEach 5 mL of oral solution for oral administration contains: Prednisone..............................
    Active IngredientPrednisone
    Dosage FormSolution
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyRoxane

    3 of 6  
    Drug NameRayos
    Drug LabelThe active ingredient in RAYOS is prednisone (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for prednisone is C21H26O5. The chemical name for prednisone is 17,21-dihydrox...
    Active IngredientPrednisone
    Dosage FormTablet, delayed release
    RouteOral
    Strength1mg; 5mg; 2mg
    Market StatusPrescription
    CompanyHorizon Pharma

    4 of 6  
    Drug NamePrednisone
    PubMed HealthPrednisone (By mouth)
    Drug ClassesEndocrine-Metabolic Agent, Immune Suppreant
    Drug LabelEach tablet for oral administration contains:Prednisone.............................................................1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mgEach 5 mL of oral solution for oral administration contains:Prednisone........................
    Active IngredientPrednisone
    Dosage FormTablet; Solution
    RouteOral
    Strength2.5mg; 1mg; 5mg; 50mg; 10mg; 5mg/5ml; 20mg
    Market StatusPrescription
    CompanyVintage Pharms; Jubilant Cadista; Hikma Pharms; Roxane; Watson Labs; Mutual Pharm; Contract Pharmacal

    5 of 6  
    Drug NamePrednisone intensol
    PubMed HealthPrednisone (By mouth)
    Drug ClassesEndocrine-Metabolic Agent, Immune Suppreant
    Drug LabelEach tablet for oral administration contains: Prednisone.....................................................1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mgEach 5 mL of oral solution for oral administration contains: Prednisone..............................
    Active IngredientPrednisone
    Dosage FormSolution
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyRoxane

    6 of 6  
    Drug NameRayos
    Drug LabelThe active ingredient in RAYOS is prednisone (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for prednisone is C21H26O5. The chemical name for prednisone is 17,21-dihydrox...
    Active IngredientPrednisone
    Dosage FormTablet, delayed release
    RouteOral
    Strength1mg; 5mg; 2mg
    Market StatusPrescription
    CompanyHorizon Pharma

    4.2 Therapeutic Uses

    Anti-Inflammatory Agents; Antineoplastic Agents, Hormonal; Glucocorticoids

    National Library of Medicine's Medical Subject Headings. Prednisone. Online file (MeSH, 2016). Available from, as of October 28, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html

    Prednisone is usually considered the oral glucocorticoid of choice for anti-inflammatory or immunosuppressant effects. Because it has only minimal mineralocorticoid properties, the drug is inadequate alone for the management of adrenocortical insufficiency. If prednisone is used in the treatment of this condition, concomitant therapy with a mineralocorticoid is also required.

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3122-3

    Prednisone tablets and solutions are indicated in the following conditions: Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Prednisone (Pednisone Tablet) Prednisone (Prednisone Solution) Prednisone Intensol (Prednisone Intensol Solution, Concentrate) (Updated: July 2016). Available from, as of November 22, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3115aef0-fd50-4ec8-a064-3effb695f3f2

    Prednisone tablets and solutions are indicated in the following conditions: Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Prednisone (Pednisone Tablet) Prednisone (Prednisone Solution) Prednisone Intensol (Prednisone Intensol Solution, Concentrate) (Updated: July 2016). Available from, as of November 22, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3115aef0-fd50-4ec8-a064-3effb695f3f2

    For more Therapeutic Uses (Complete) data for PREDNISONE (19 total), please visit the HSDB record page.

    4.3 Drug Warning

    The profound effects of prednisone on the immune system place patients at increased risk of developing infections of various types. Prednisone may mask some of the signs of infection, and may decrease host resistance and interfere with the ability to localize infections. During prednisone therapy, a polymorphonuclear leukocytosis may develop and may give rise to confusion in the diagnosis of infection. This elevation is dose-related.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 302 (1981)

    Psychiatric reactions have been reported in 4-36% of patients. These disturbances may take various forms, for example, insomnia, changes in mood or psyche, and psychopathies of the manic-depressive or schizophrenic type.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 302 (1981)

    Ophthalmic complications include the development of posterior subcapsular cataracts, and increased intraocular pressure which may lead to glaucoma. In patients with ocular herpes simplex, it may cause corneal perforation.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 302 (1981)

    There are numerous endocrine side effects. Most frequent is development of the Cushingoid state. Fatty deposits in the mediastinum causing mediastinal widening may simulate mediastinal lymphadenopathy. Menstrual irregularities, including amenorrhoea, may occur. There may be secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness. The processes of recovery of normal pituitary and adrenal function require about 1 year in some patients. There may be stunted growth and delayed skeletal maturation in children. Prednisone causes decreased carbohydrate tolerance and may unmask the features of latent diabetes.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 301-2 (1981)

    For more Drug Warnings (Complete) data for PREDNISONE (38 total), please visit the HSDB record page.

    4.4 Drug Indication

    Prednisone is indicated as an anti-inflammatory or immunosuppressive drug for allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, infectious, endocrine, or neoplastic conditions as well as in organ transplant.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Prednisone has a short duration of action as the half life is 2-3 hours. Corticosteroids have a wide therapeutic window as patients make require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

    5.2 MeSH Pharmacological Classification

    Antineoplastic Agents, Hormonal

    Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)

    Glucocorticoids

    A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)

    Anti-Inflammatory Agents

    Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    PREDNISONE
    5.3.2 FDA UNII
    VB0R961HZT
    5.3.3 Pharmacological Classes
    Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
    5.4 ATC Code

    A - Alimentary tract and metabolism

    A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

    A07E - Intestinal antiinflammatory agents

    A07EA - Corticosteroids acting locally

    A07EA03 - Prednisone

    H - Systemic hormonal preparations, excl. sex hormones and insulins

    H02 - Corticosteroids for systemic use

    H02A - Corticosteroids for systemic use, plain

    H02AB - Glucocorticoids

    H02AB07 - Prednisone

    5.5 Absorption, Distribution and Excretion

    Absorption

    Oral prednisone has a Tmax of 2 hours, while the delayed-release formulation has a Tmax of 6-6.5 hours. A 5mg dose of prednisone has an AUC of 572mL/min/1.73m2, a 20mg dose of prednisone has an AUC of 1034mL/min/1.73m2, and a 50mg dose of prednisone has an AUC of 2271mL/min/1.73m2. Data regarding the Cmax of prednisone is not readily available.

    Route of Elimination

    Prednisone is excreted mainly in the urine as sulfate and glucuronide conjugates.

    Volume of Distribution

    Data regarding the volume of distribution for prednisone is not readily available. However, a 0.15mg/kg dose of prednisolone has a volume of distribution of 29.3L, while a 0.30mg/kg dose has a volume of distribution of 44.2L.

    Clearance

    Data regarding the clearance of prednisone is not readily available. A 5.5g/h/kg infusion of prednisolone has an average clearance of 0.0660.12L/h/kg, while a 0.150.03L/h/kg infusion has an average clearance of 0.15L/h/kg.

    Thirty minutes after iv administration of (3)H-prednisone to a monkey, the concentration of prednisone was highest in the kidney. The drug was also found in the liver, spleen, lung, small intestine, serum and bile. The concentration of prednisolone was highest in the liver. It was also found in the kidney, pancreas, spleen, lung, small intestine, serum and bile.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 300 (1981)

    Prednisone is readily absorbed from the gut. Serum concentrations of prednisone and prednisolone, its active metabolite, have been found to be maximal 1 hour after oral administration of a 5-mg tablet of prednisone to beagle dogs. Following both ip and oral administration of prednisone to mice, serum levels of prednisone, prednisolone and other metabolites were maximal at 15 min. These levels were higher in mice given ip injections of prednisone than in those receiving the same doses by the oral route. Oral administration of prednisone to dogs and monkeys led to serum levels comparable with those following iv injections, but individual variations were relatively large.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 299 (1981)

    Prednisone is readily absorbed from the gut. In a series of 22 normal subjects, the mean peak serum concentration was 930 ug/L (range, 508-1579) following oral administration of a 50 mg tablet.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 303 (1981)

    The protein binding characteristics of prednisone and prednisolone, alone and together, in human and rabbit plasma and human serum albumin, are reported. The kinetics of prednisolone binding were nonlinear and those of prednisone were linear in both human and rabbit plasma; prednisone binding was linear with human serum albumin, although to a lesser degree. It is suggested that prednisone binds to proteins other than albumin in plasma. Binding of prednisone was not influenced by prednisolone. The results support the hypothesis that the protein binding characteristics of prednisone and prednisolone do not explain the reported nonlinear pharmacokinetics of prednisone.

    PMID:3593903 Ferry JJ, Wagner JG; Biopharm Drug Dispos 8 (3): 261-72 (1987)

    Administration of physiologic doses unlikely to adversely affect infant. FDA Category: C (C = Studies in laboratory animals have revealed adverse effects on the fetus (teratogenic, embryocidal, etc.) but there are no controlled studies in pregnant women. The benefits from use of the drug in pregnant women may be acceptable despite its potential risks, or there are no laboratory animal studies or adequate studies in pregnant women.) /Adrenocorticosteroids/ /from table II/

    Stockton, D.L. and A.S. Paller. J Am Acad Dermatol 23 (1):87-103 (1990)

    5.6 Metabolism/Metabolites

    Prednisoneis metabolized to 17,21-dihydroxy-pregnan-1,4,6-trien-3,11,30-trione (M-XVII), 20-dihydro-prednisone (M-V), 6hydroxy-prednisone (M-XII), 6-hydroxy-prednisone (M-XIII), or 20-dihydro-prednisone (M-IV).20-dihydro-prednisone is metabolized to 17,20,21-trihydroxy-5-pregn-1-en-3,11-dione(M-XVIII). Prednison is reversibly metabolized to [prednisolone].Prednisolone is metabolized to 6-prednisolone (M-XI), 20-dihydro-prednisolone (M-III), 20-dihydro-prednisolone (M-II), 6hydroxy-prednisolone (M-VII), or 6hydroxy-prednisolone(M-VI).6hydroxy-prednisolone is metabolized to 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-X).6hydroxy-prednisolone is metabolized to 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-VIII), 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-IX), and 6,11,17,21-tetrahydroxy-5-pregn-1-en-3,20-dione (M-XIV).MVIII is metabolized to 6,11,17,20,21-pentahydroxy-5-pregn-1-en-3-one (M-XV) and then to MXIV, while MIX is metabolized to 6,11,17,20,21-pentahydroxy-5-pregn-1-en-3-one (M-XVI) and then to MXIV.These metabolites and their glucuronide conjugates are excreted predominantly in the urine.

    In one study after an oral dose of prednisone, the plasma prednisolone concentration peaked between 60 and 120 min and then declined exponentially. After rapid iv injection of steroid, the plasma prednisolone concentration peaked within 10 to 20 min. An initial rapid distribution phase succeeded by a slower decay phase was expressed by a biphasic exponential disappearance curve of the plasma prednisolone concentration versus time. Plasma prednisolone concentrations achieved with an oral dose of prednisone were in the same range as those obtained during the second phase after iv administration.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 303 (1981)

    Reduction of the 11-oxo to the 11alpha-hydroxyl group by the enzyme 11beta-hydroxydehydrogenase converts prednisone to prednisolone, its biologically active form. This reaction takes place mainly in the liver, and may proceed satisfactorily even in the presence of liver disease

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 303 (1981)

    In vitro, prednisone is converted to prednisolone by liver, lung and renal tissue. Conversely, prednisolone is converted to prednisone by renal tissue.

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 300 (1981)

    ... The aim of this work was to evaluate the effects of these corticosteroids on the expression of several forms of cytochromes p450, including p450 1A2, 2D6, 2E1, and 3A, and on cyclosporin A oxidase activity in human liver. For this purpose, human hepatocytes prepared from lobectomies were maintained in culture in a serum-free medium, in collagen-coated dishes, for 96-144 hr, in the absence or presence of 50-100 uM corticosteroids, rifampicin, or dexamethasone. To mimic more closely the current clinical protocol, hepatocyte cultures were also co-treated with corticosteroids and cyclosporin A or ketoconazole (a selective inhibitor of cytochromes p450 3A). Cyclosporin A oxidase activity, intracellular retention of cyclosporin A oxidized metabolites within hepatocytes, accumulation of cytochromes p450 proteins and corresponding messages, and de novo synthesis and half-lives of these cytochromes p450 were measured in parallel in these cultures. Our results, obtained from seven different hepatocyte cultures, showed that 1) dexamethasone and prednisone, but not prednisolone or methylprednisolone, were inducers of cytochrome p450 3A, at the level of protein and mRNA accumulation, as well as of cyclosporin A oxidase activity, known to be predominantly catalyzed by these cytochromes p450; 2) although corticosteroids are known to be metabolized in human liver, notably by cytochrome p450 3A, partial or total inhibition of this cytochromes p450 by cyclosporin or ketoconazole, respectively, did not affect the inducing efficiency of these molecules; 3) corticosteroids did not affect the half-life of cytochrome p450 3A or the accumulation of other forms of cytochromes p450, including 1A2, 2D6, and 2E1; 4) chronic treatment of cells with cyclosporin did not affect cytochrome p450 3A accumulation; 5) corticosteroids were all competitive inhibitors of cyclosporin A oxidase in human liver microsomes, with Ki values of 61 + or - 12, 125 + or - 25, 190 + or - 38, and 210 + or - 42 uM for dexamethasone, prednisolone, prednisone, and methylprednisolone, respectively; and 6) chronic treatment of cells with corticosteroids did not influence the excretion of oxidized metabolites of cyclosporin from the cells.

    PMID:1614409 Pichard L et al; Mol Pharmacol 41 (6): 1047-55 (1992)

    5.7 Biological Half-Life

    Prednisone and its active metabolite [prednisolone] have half lives of 2-3 hours from both immediate and delayed release preparations.

    In a series of 22 normal subjects, the mean peak serum concentration was 930 ug/L (range, 508-1579) following oral administration of a 50 mg tablet. The overall mean serum half-life was 2.95 hours

    IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V26 303 (1981)

    5.8 Mechanism of Action

    Prednisone is first metabolized in the liver to its active form, prednisolone, a glucocorticoid agonist corticosteroid. The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.

    In physiologic doses, corticosteroids are administered to replace deficient endogenous hormones. In larger (pharmacologic) doses, glucocorticoids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown. The drugs suppress the immune response by reducing activity and volume of the lymphatic system, producing lymphocytopenia, decreasing immunoglobulin and complement concentrations, decreasing passage of immune complexes through basement membranes, and possibly by depressing reactivity of tissue to antigen-antibody interactions. Glucocorticoids stimulate erythroid cells of bone marrow, prolong survival time of erythrocytes and platelets, and produce neutrophilia and eosinopenia. Glucocorticoids promote gluconeogenesis, redistribution of fat from peripheral to central areas of the body, and protein catabolism, which results in negative nitrogen balance. They reduce intestinal absorption and increase renal excretion of calcium. /Corticosteroids/

    American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3097

    Glucocorticoids are capable of suppressing the inflammatory process through numerous pathways. They interact with specific intracellular receptor proteins in target tissues to alter the expression of corticosteroid-responsive genes. Glucocorticoid-specific receptors in the cell cytoplasm bind with steroid ligands to form hormone-receptor complexes that eventually translocate to the cell nucleus. There these complexes bind to specific DNA sequences and alter their expression. The complexes may induce the transcription of mRNA leading to synthesis of new proteins. Such proteins include lipocortin, a protein known to inhibit PLA2a and thereby block the synthesis of prostaglandins, leukotrienes, and PAF. Glucocorticoids also inhibit the production of other mediators including AA metabolites such as COX, cytokines, the interleukins, adhesion molecules, and enzymes such as collagenase. /Glucocorticoids/

    Kahn, C.M. (Ed.); The Merck Veterinary Manual 9th ed. Merck & Co. Whitehouse Station, NJ. 2005, p. 2128

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    06-Jan-2021
    15-Oct-2024
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    Drugs in Development

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    • Development Update
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy's Laboratories Announces the Launch of Abiraterone Acetate Tablets USP, 250 mg in the U.S. Market

    Details:

    Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga® (abiraterone acetate), is an anticancer medication. It works by preventing androgen (male hormone) production in man.


    Lead Product(s): Abiraterone Acetate,Prednisone

    Therapeutic Area: Oncology Brand Name: Abiraterone Acetate-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 19, 2020

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    Lead Product(s) : Abiraterone Acetate,Prednisone

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories Announces the Launch of Abiraterone Acetate Tablets USP, 250 mg in the U....

    Details : Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga® (abiraterone acetate), is an anticancer medication. It works by preventing androgen (male hormone) production in man.

    Brand Name : Abiraterone Acetate-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 19, 2020

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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Strides Receives USFDA Approval for Prednisone Tablets

    Details:

    Strides Pharma's Prednisone Tablets USP, 10 mg and 20 mg is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co. (Pharmacia).


    Lead Product(s): Prednisone

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 12, 2021

    Strides Pharma Science

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    Strides Pharma Science

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    Lead Product(s) : Prednisone

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Strides Receives USFDA Approval for Prednisone Tablets

    Details : Strides Pharma's Prednisone Tablets USP, 10 mg and 20 mg is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co. (Pharmacia).

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 12, 2021

    Strides Pharma Science

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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Strides Receives USFDA Approval for Prednisone Tablets

    Details:

    Prednisone is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co.


    Lead Product(s): Prednisone

    Therapeutic Area: Gastroenterology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 23, 2020

    Strides Pharma Science

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    Strides Pharma Science

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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Prednisone

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Strides Receives USFDA Approval for Prednisone Tablets

    Details : Prednisone is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 23, 2020

    Strides Pharma Science

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    Strides Receives USFDA Approval for Prednisone Tablets

    Details:

    Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Prednisone Tablets USP, 1 mg from the United States Food & Drug Administration (USFDA).


    Lead Product(s): Prednisone

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 03, 2020

    Strides Pharma Science

    04

    Strides Pharma Science

    India
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Prednisone

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Strides Receives USFDA Approval for Prednisone Tablets

    Details : Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Prednisone Tablets USP, 1 mg from the United States Food & Drug Administration (...

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 03, 2020

    Strides Pharma Science

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    Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances & suspensions.

    EVER Pharma gains EU marketing authorization for value-added Cabazitaxel

    Details:

    Cabazitaxel EVER Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer.


    Lead Product(s): Cabazitaxel,Prednisone

    Therapeutic Area: Oncology Brand Name: Cabazitaxel EVER Pharma

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 21, 2020

    Ever Pharma CB

    05

    Ever Pharma

    Austria
    arrow
    Pharma Manufacturing 2024
    Not Confirmed
    • fda
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    • WHO-GMP
    Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances & suspensions.

    Lead Product(s) : Cabazitaxel,Prednisone

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    EVER Pharma gains EU marketing authorization for value-added Cabazitaxel

    Details : Cabazitaxel EVER Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer.

    Brand Name : Cabazitaxel EVER Pharma

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 21, 2020

    Ever Pharma CB

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    Myrtelle Reports NAA Reduction in Phase 1/2 Gene Therapy Trial For Canavan Disease

    Details:

    MYR-101 (rAAV-Olig001-ASPA) is a gene therapy candidate, which is intended to restore ASPA function and brain development in patients with Canavan Disease.


    Lead Product(s): MYR-101,Levetiracetam,Prednisone

    Therapeutic Area: Genetic Disease Brand Name: MYR-101

    Study Phase: Phase I/ Phase IIProduct Type: Cell and Gene therapy

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 10, 2024

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    06

    Myrtelle

    U.S.A
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    Pharma Manufacturing 2024
    Not Confirmed

    Myrtelle

    U.S.A
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    Pharma Manufacturing 2024
    Not Confirmed
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    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : MYR-101,Levetiracetam,Prednisone

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Myrtelle Reports NAA Reduction in Phase 1/2 Gene Therapy Trial For Canavan Disease

    Details : MYR-101 (rAAV-Olig001-ASPA) is a gene therapy candidate, which is intended to restore ASPA function and brain development in patients with Canavan Disease.

    Brand Name : MYR-101

    Molecule Type : Cell and Gene therapy

    Upfront Cash : Not Applicable

    October 10, 2024

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    Positive Phase III Results for Gazyva Show Superiority in Lupus Nephritis Treatment

    Details:

    Gazyva (obinutuzumab) is a humanized mAb designed to attach to CD20, being developed for people with active lupus nephritis.


    Lead Product(s): Obinutuzumab,Prednisone,Methylprednisolone

    Therapeutic Area: Nephrology Brand Name: Gazyva

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 26, 2024

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    07

    Genentech

    U.S.A
    arrow
    Pharma Manufacturing 2024
    Not Confirmed

    Genentech

    U.S.A
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    Pharma Manufacturing 2024
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Obinutuzumab,Prednisone,Methylprednisolone

    Therapeutic Area : Nephrology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Positive Phase III Results for Gazyva Show Superiority in Lupus Nephritis Treatment

    Details : Gazyva (obinutuzumab) is a humanized mAb designed to attach to CD20, being developed for people with active lupus nephritis.

    Brand Name : Gazyva

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 26, 2024

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    FDA Approves FoundationOne®CDx As Companion Diagnostic for Prostate Cancer

    Details:

    Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone indicated for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer.


    Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone

    Therapeutic Area: Oncology Brand Name: Lynparza

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Foundation Medicine

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 03, 2024

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    08

    AstraZeneca

    United Kingdom
    arrow
    Pharma Manufacturing 2024
    Not Confirmed

    AstraZeneca

    United Kingdom
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    Pharma Manufacturing 2024
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Olaparib,Abiraterone Acetate,Prednisone

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Foundation Medicine

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Approves FoundationOne®CDx As Companion Diagnostic for Prostate Cancer

    Details : Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone indicated for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer.

    Brand Name : Lynparza

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 03, 2024

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    FDA Approves FoundationOne®Liquid CDx as Companion Diagnostic for AKEEGA®

    Details:

    Akeega (niraparib, abiraterone acetate) is a tablet works by inhibiting approved for BRCA-mutated mCRPC in adults. The FDA has approved FoundationOne Liquid CDx as its companion diagnostic.


    Lead Product(s): Niraparib Tosylate,Abiraterone Acetate,Prednisone

    Therapeutic Area: Oncology Brand Name: Akeega

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: JANSSEN BIOTECH

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 01, 2024

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    09

    Foundation Medicine

    U.S.A
    arrow
    Pharma Manufacturing 2024
    Not Confirmed

    Foundation Medicine

    U.S.A
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    Pharma Manufacturing 2024
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Niraparib Tosylate,Abiraterone Acetate,Prednisone

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : JANSSEN BIOTECH

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Approves FoundationOne®Liquid CDx as Companion Diagnostic for AKEEGA®

    Details : Akeega (niraparib, abiraterone acetate) is a tablet works by inhibiting approved for BRCA-mutated mCRPC in adults. The FDA has approved FoundationOne Liquid CDx as its companion diagnostic.

    Brand Name : Akeega

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 01, 2024

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    First Patient Treated in Phase 2 GvHD Trial

    Details:

    CYP-001 is Cynata's Cymerus™ off-the-shelf iPSC[1]-derived MSC[2] product candidate for intravenous infusion, which is being evaluated for the treatment of acute graft versus host disease.


    Lead Product(s): CYP-001,Prednisone

    Therapeutic Area: Immunology Brand Name: CYP-001

    Study Phase: Phase IIProduct Type: Cell and Gene therapy

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 04, 2024

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    10

    Cynata Therapeutics

    Australia
    arrow
    Pharma Manufacturing 2024
    Not Confirmed

    Cynata Therapeutics

    Australia
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    Pharma Manufacturing 2024
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : CYP-001,Prednisone

    Therapeutic Area : Immunology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    First Patient Treated in Phase 2 GvHD Trial

    Details : CYP-001 is Cynata's Cymerus™ off-the-shelf iPSC[1]-derived MSC[2] product candidate for intravenous infusion, which is being evaluated for the treatment of acute graft versus host disease.

    Brand Name : CYP-001

    Molecule Type : Cell and Gene therapy

    Upfront Cash : Not Applicable

    March 04, 2024

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    01

    Aspen Pharmacare Holdings

    South Africa
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    euroPLX 86 Munich
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Contact Supplier Contact Supplier
    Flag South Africa
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Australia

    prednisone

    Brand Name : Panafcort

    Dosage Form : tablet

    Dosage Strength : 5 mg

    Packaging : 60

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

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    02

    Aspen Pharmacare Holdings

    South Africa
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    euroPLX 86 Munich
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Regulatory Info :

    Registration Country : Australia

    prednisone

    Brand Name : Panafcort

    Dosage Form : tablet

    Dosage Strength : 1 mg

    Packaging : 100

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

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    03

    Aspen Pharmacare Holdings

    South Africa
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    euroPLX 86 Munich
    Not Confirmed
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    Flag South Africa
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    Regulatory Info :

    Registration Country : Australia

    prednisone

    Brand Name : Predsone

    Dosage Form : tablet

    Dosage Strength : 1 mg

    Packaging : 100

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    04

    Aspen Pharmacare Holdings

    South Africa
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    euroPLX 86 Munich
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag South Africa
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    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Australia

    prednisone

    Brand Name : Panafcort

    Dosage Form : tablet

    Dosage Strength : 1 mg

    Packaging : 100

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

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    05

    Aspen Pharmacare Holdings

    South Africa
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    euroPLX 86 Munich
    Not Confirmed
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    Flag South Africa
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    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Australia

    prednisone

    Brand Name : Predsone

    Dosage Form : tablet

    Dosage Strength : 1 mg

    Packaging : 100

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

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    06

    Aspen Pharmacare Holdings

    South Africa
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    euroPLX 86 Munich
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Regulatory Info :

    Registration Country : Australia

    prednisone

    Brand Name : Panafcort

    Dosage Form : tablet

    Dosage Strength : 5 mg

    Packaging : 60

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    Aspen API Comapny Banner

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    07

    Aspen Pharmacare Holdings

    South Africa
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    euroPLX 86 Munich
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    Regulatory Info :

    Registration Country : Australia

    prednisone

    Brand Name : Panafcort

    Dosage Form : tablet

    Dosage Strength : 25 mg

    Packaging : 30

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    08

    Strides Pharma Science

    India
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    CPhI India 2024
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Contact Supplier Contact Supplier
    Flag India
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    Regulatory Info : RX

    Registration Country : USA

    PREDNISONE

    Brand Name : PREDNISONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 20MG

    Packaging :

    Approval Date : 2021-02-11

    Application Number : 208412

    Regulatory Info : RX

    Registration Country : USA

    Strides Pharma Science

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    09

    Strides Pharma Science

    India
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Contact Supplier Contact Supplier
    Flag India
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    Registration Country : India

    Prednisone

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 1MG

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    Approval Date :

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    Regulatory Info :

    Registration Country : India

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    10

    Strides Pharma Science

    India
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    Attending
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Contact Supplier Contact Supplier
    Flag India
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    Regulatory Info :

    Registration Country : India

    Prednisone

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

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    Regulatory Info :

    Registration Country : India

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 80352

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 84122

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    DOSAGE - TABLET;ORAL - 50MG

    USFDA APPLICATION NUMBER - 84283

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    DOSAGE - TABLET;ORAL - 20MG

    USFDA APPLICATION NUMBER - 87342

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    DOSAGE - TABLET;ORAL - 1MG

    USFDA APPLICATION NUMBER - 87800

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    DOSAGE - TABLET;ORAL - 2.5MG

    USFDA APPLICATION NUMBER - 87801

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    01

    Jai Radhe Sales

    India
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    CPhI India 2024
    Attending
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    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

    Brand Name : Croscarmellose Sodium

    Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders

    Excipient Details : Croscarmellose Sodium, an internally cross-linked sodium carboxymethylcellulose is mostly used as a super disintegrant in various oral solid dosage forms such as tablets, capsules and orodispersible tablets (ODTs).

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Croscarmellose Sodium

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    02

    Faran Shimi Pharmaceutical

    Iran
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    Fi Europe 2024
    Not Confirmed
    • fda
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    Dosage Form : Tablet

    Grade : Oral

    Category : Disintegrants & Superdisintegrants

    Brand Name : Croscarmellose Sodium

    Application : Disintegrants & Superdisintegrants

    Excipient Details : Croscarmellose sodium is used as a super disintegrant in various oral solid dosage forms, such as tablets and ODTs.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Croscarmellose Sodium

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    03

    Faran Shimi Pharmaceutical

    Iran
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    Fi Europe 2024
    Not Confirmed
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    Dosage Form : Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : Lactose Monohydrate

    Application : Fillers, Diluents & Binders

    Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Lactose Monohydrate

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    04

    Boai NKY Pharmaceuticals Ltd

    China
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    CPhI India 2024
    Exhibiting
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    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Capsule, Tablet

    Grade : Oral (Pharma Grade)

    Category : Fillers, Diluents & Binders

    Brand Name : KoVidone® K25

    Application : Fillers, Diluents & Binders

    Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Polyvinylpyrrolidone

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    05

    Gangwal Healthcare

    India
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    CPhI India 2024
    Booth #8.Q10
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    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Brand Name : STARLOSE®

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

    Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

    Pharmacopoeia Ref : IP/EP/USP-NF/IH

    Technical Specs : NA

    Ingredient(s) : Lactose Monohydrate

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    06

    Nanjing Well Pharmaceutical

    China
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    Fi Europe 2024
    Not Confirmed
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    Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

    Dosage Form : Injectable / Parenteral

    Grade : Parenteral

    Category : Parenteral

    Brand Name : Lactose Monohydrate

    Application : Parenteral

    Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.

    Pharmacopoeia Ref : ChP/USP/EP/JP

    Technical Specs : NA

    Ingredient(s) : Lactose Monohydrate

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    07

    Pluviaendo

    Turkey
    Fi Europe 2024
    Not Confirmed
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    08

    Faran Shimi Pharmaceutical

    Iran
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    Dosage Form : Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : Polyvinylpyrrolidone

    Application : Fillers, Diluents & Binders

    Excipient Details : Polyvinylpyrrolidone is used as a low viscosity wet binder in solid dosage forms such as tablets.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Polyvinylpyrrolidone

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    09

    Faran Shimi Pharmaceutical

    Iran
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    Fi Europe 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    Dosage Form : Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : Pregelatinized Corn Starch

    Application : Fillers, Diluents & Binders

    Excipient Details : Corn starch is used as a filler and binder in pharmaceutical oral solid dosage forms, including tablets.

    Pharmacopoeia Ref : BP/USP

    Technical Specs : NA

    Ingredient(s) : Corn Starch, Pregelatinized

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    10

    Pluviaendo

    Turkey
    Fi Europe 2024
    Not Confirmed
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