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    Chemistry

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    Also known as: 14484-47-0, Azacort, Calcort, Oxazacort, Flantadin, Emflaza
    Molecular Formula
    C25H31NO6
    Molecular Weight
    441.5  g/mol
    InChI Key
    FBHSPRKOSMHSIF-GRMWVWQJSA-N
    FDA UNII
    KR5YZ6AE4B
    Deflazacort
    Deflazacort is a synthetic glucocorticoid prodrug, with anti-inflammatory and immunomodulating properties. Upon administration, the active metabolite of deflazacort, 21-desacetyl deflazacort, binds to and activates tissue glucocorticoid receptors. This results in the inhibition of specific leukocyte functions and the inhibition of proinflammatory cytokine production.
    Deflazacort is a Corticosteroid. The mechanism of action of deflazacort is as a Corticosteroid Hormone Receptor Agonist.
    1 2D Structure

    Deflazacort

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [2-[(1S,2S,4R,8S,9S,11S,12S,13R)-11-hydroxy-6,9,13-trimethyl-16-oxo-5-oxa-7-azapentacyclo[10.8.0.02,9.04,8.013,18]icosa-6,14,17-trien-8-yl]-2-oxoethyl] acetate
    2.1.2 InChI
    InChI=1S/C25H31NO6/c1-13-26-25(20(30)12-31-14(2)27)21(32-13)10-18-17-6-5-15-9-16(28)7-8-23(15,3)22(17)19(29)11-24(18,25)4/h7-9,17-19,21-22,29H,5-6,10-12H2,1-4H3/t17-,18-,19-,21+,22+,23-,24-,25+/m0/s1
    2.1.3 InChI Key
    FBHSPRKOSMHSIF-GRMWVWQJSA-N
    2.1.4 Canonical SMILES
    CC1=NC2(C(O1)CC3C2(CC(C4C3CCC5=CC(=O)C=CC45C)O)C)C(=O)COC(=O)C
    2.1.5 Isomeric SMILES
    CC1=N[C@@]2([C@H](O1)C[C@@H]3[C@@]2(C[C@@H]([C@H]4[C@H]3CCC5=CC(=O)C=C[C@]45C)O)C)C(=O)COC(=O)C
    2.2 Other Identifiers
    2.2.1 UNII
    KR5YZ6AE4B
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Calcort

    2. Dezacor

    3. Emflaza

    4. Zamene

    2.3.2 Depositor-Supplied Synonyms

    1. 14484-47-0

    2. Azacort

    3. Calcort

    4. Oxazacort

    5. Flantadin

    6. Emflaza

    7. Cortax

    8. Deflan

    9. Mdl 458

    10. Mdl-458

    11. L-5458

    12. Kr5yz6ae4b

    13. Mdl458

    14. Dezacor

    15. Lantadin

    16. Dsstox_cid_378

    17. Dsstox_rid_75552

    18. Dsstox_gsid_20378

    19. 2-((6ar,6bs,7s,8as,8bs,11ar,12as,12bs)-7-hydroxy-6a,8a,10-trimethyl-4-oxo-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bh-naphtho[2',1':4,5]indeno[1,2-d]oxazol-8b-yl)-2-oxoethyl Acetate

    20. Deflazacortum

    21. Decortil

    22. Deflanil

    23. Enzocort

    24. Deflazacort (calcort)

    25. 2-[(4ar,4bs,5s,6as,6bs,9ar,10as,10bs)-5-hydroxy-4a,6a,8-trimethyl-2-oxo-2,4a,4b,5,6,6a,9a,10,10a,10b,11,12-dodecahydro-6bh-naphtho[2',1':4,5]indeno[1,2-d][1,3]oxazol-6b-yl]-2-oxoethyl Acetate

    26. Cas-14484-47-0

    27. Dl-458-it

    28. Unii-kr5yz6ae4b

    29. Deflazacortum [inn-latin]

    30. Deflazacort [usan:inn:ban]

    31. Einecs 238-483-7

    32. Emflaza (tn)

    33. Mfcd00866106

    34. Deflazacort [mi]

    35. Deflazacort [inn]

    36. Deflazacort (usan/inn)

    37. Deflazacort [usan]

    38. Schembl4018

    39. Deflazacort [mart.]

    40. Deflazacort [usp-rs]

    41. Deflazacort [who-dd]

    42. Dl-458it

    43. Gtpl9477

    44. Chembl1201891

    45. Dtxsid9020378

    46. Deflazacort, >=98% (hplc)

    47. Deflazacort [orange Book]

    48. Chebi:135720

    49. Hms3714d15

    50. Bcp08474

    51. Zinc4212809

    52. Tox21_112506

    53. Tox21_301415

    54. Bbl036672

    55. S1888

    56. Stl559051

    57. Akos015895199

    58. Tox21_112506_1

    59. Ccg-220817

    60. Db11921

    61. Ks-1158

    62. Ncgc00255189-01

    63. Ncgc00263521-01

    64. 11beta,21-dihydroxy-2'-methyl-5'betah-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione 21-acetate

    65. Hy-13609

    66. Deflazacort 100 Microg/ml In Acetonitrile

    67. D4523

    68. D03671

    69. T70289

    70. Ab01274724-01

    71. Ab01274724_02

    72. 484d470

    73. Q779118

    74. Q-101371

    75. 3-amino-3-(4-chloro-3-nitro-phenyl)-propionicacid

    76. Deflazacort, United States Pharmacopeia (usp) Reference Standard

    77. 11b,21-dihydroxy-2'-methyl-5'bh-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 21-acetate

    78. (11beta,16beta)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione

    79. [2-[(1s,2s,4r,8s,9s,11s,12s,13r)-11-hydroxy-6,9,13-trimethyl-16-oxo-5-oxa-7-azapentacyclo[10.8.0.02,9.04,8.013,18]icosa-6,14,17-trien-8-yl]-2-oxoethyl] Acetate

    80. 11.beta.,21-dihydroxy-2'-methyl-5'.beta.h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione 21-acetate

    81. 2-((6ar,6bs,7s,8as,8bs,11ar,12as,12bs)-7-hydroxy-6a,8a,10-trimethyl-4-oxo-2,4,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-1h-naphtho[2',1':4,5]indeno[1,2-d]oxazol-8b-yl)-2-oxoethyl Acetate

    82. 5'-beta-h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 11-beta,21-dihydroxy-2'-methyl-, 21-acetate

    83. 5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11.beta.,16.beta.)-

    84. 5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11beta,16beta)-

    2.4 Create Date
    2005-08-09
    3 Chemical and Physical Properties
    Molecular Weight 441.5 g/mol
    Molecular Formula C25H31NO6
    XLogP32
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count4
    Exact Mass441.21513771 g/mol
    Monoisotopic Mass441.21513771 g/mol
    Topological Polar Surface Area102 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity996
    Isotope Atom Count0
    Defined Atom Stereocenter Count8
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Deflazacort is indicated for the treatment of Duchenne Muscular Dystrophy (DMD) in patients 2 years of age and older.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Deflazacort exerts anti-inflammatory activity in DMD, likely improving various symptoms, including muscle weakness and cardiorespiratory symptoms in addition to delaying their onset. This allows for an increased quality of life and prevents the necessity for surgical procedures, such as those for scoliosis, which is associated with DMD. Studies showed significant preservation of muscle mass in patients generally treated with 0.9 mg/kg/day of deflazacort compared to a control group. The following findings are based on clinical studies using deflazacort on a long term basis: **Effects on muscle strength** At age 16, individuals treated with long-term deflazacort had 63 4% score in muscle strength compared to a mean muscle strength score of 31 3% for control patients. Significant improvements in climbing stairs and rising from a supine position were also seen in patients taking deflazacort. **Effects on ambulation** Ambulation was significantly higher by 12 years of age and 18 years of age in patients taking deflazacort when compared with the control group. The control group showed a mean loss of ambulation of 2 years sooner than with deflazacort treatment. **Effects on cardiac function** Mean left ventricular ejection fraction (a measure of cardiac function) was higher in patients treated with deflazacort over the long term. Preservation of cardiac function was demonstrated by a mean difference in ejection fraction of about 7%, favoring study groups taking deflazacort over control groups. **Effects on spinal alignment** Children treated with deflazacort also significantly lowered the rate and severity of scoliosis and eliminated the need for scoliosis surgery after long-term treatment.

    5.2 MeSH Pharmacological Classification

    Anti-Inflammatory Agents

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

    Immunosuppressive Agents

    Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DEFLAZACORT
    5.3.2 FDA UNII
    KR5YZ6AE4B
    5.3.3 Pharmacological Classes
    Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
    5.4 ATC Code

    H02AB13

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

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

    H02 - Corticosteroids for systemic use

    H02A - Corticosteroids for systemic use, plain

    H02AB - Glucocorticoids

    H02AB13 - Deflazacort

    5.5 Absorption, Distribution and Excretion

    Absorption

    Deflazacort is rapidly absorbed after oral administration with peak concentration occurring within 1-2 hours. One pharmacokinetic study determined an AUC (area under the curve) of 280 ng/ml h. The bioavailability of both the oral suspension and tablet are similar. In clinical studies, coadministration of deflazacort crushed with food or applesauce did not affect absorption or bioavailability.

    Route of Elimination

    Urinary excretion is the major route of deflazacort elimination, accounting for about about 70% of the excreted dose. The remainder of the dose (about 30%) is excreted in the feces. Elimination is almost completed by 24 hours post-dose. 21-deflazacort makes up about 18% of the eliminated drug in the urine.

    Volume of Distribution

    One study determined the volume of distribution to be 204 84 L.

    Clearance

    114 27 L/h, according to one noncompartmental pharmacokinetic study. The clearance of corticosteroids is enhanced in hypothyroid patients and increased in patients with hyperthyroidism. Dosing adjustments may be considered according to thyroid status. A study of corticosteroid clearance was performed in patients with a creatinine clearance of 15 mL/min or less, and determined that the active metabolite of deflazacort, 21-deflazacort was similar to that in patients with normal renal clearance.

    5.6 Metabolism/Metabolites

    After oral ingestion, deflazacort is deacetylated at position 21 by plasma esterases, producing the active metabolite 21-deflazacort. 21-deflazacort is then further metabolized by CYP3A4 to inactive metabolite products. Deflazacort 21-OH metabolism is extensive. The metabolite of deflazacort-21-OH is deflazacort 6-beta-OH.

    5.7 Biological Half-Life

    The half-life of deflazacort ranges from 1.1 to 1.9 h

    5.8 Mechanism of Action

    Deflazacort is a corticosteroid prodrug with an active metabolite, 21-deflazacort, which binds to the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects on the body. The exact mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown but likely occurs via its anti-inflammatory activities.

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LTD","supplierCountry":"INDIA","foreign_port":"BIRGUNJ","customer":"UNDISCLOSED","customerCountry":"NEPAL","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"88000","totalValueFC":"3098.6","currency":"INR","unitRateINR":88000,"date":"01-May-2025","totalValueINR":"264000","totalValueInUsd":"3098.6","indian_port":"Raxaul","hs_no":"29379090","bill_no":"1432248","productDescription":"API","marketType":"","country":"NEPAL","selfForZScoreResived":"Micronized","supplierPort":"Raxaul","supplierAddress":"3, BOTAWALA BLDG., 1ST FLOOR,, FORT, MUMBAI MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682274600,"product":"RAW CHEMICALS FOR INDUSTRIAL USE DEFLAZACORT INTERMEDIATE (NOT FOR MEDICAL USE)","address":"1001, AKASH DEEP BUILDING,26-A, BA RAKHAMBA ROAD","city":"DELHI,DELHI","supplier":"CHANGZHOU UNITED CHEMICAL CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"CORAL DRUGS PRIVATE LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1308","totalValueFC":"132709.2","currency":"USD","unitRateINR":"108760.2","date":"24-Apr-2023","totalValueINR":"10876020","totalValueInUsd":"132709.2","indian_port":"DELHI AIR","hs_no":"29221190","bill_no":"5658363","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1001, AKASH DEEP BUILDING,26-A, BA RAKHAMBA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689100200,"product":"DEFLAZACORT (THIRD COUNTRY EXPORT UNDER PARA 2.46 OF EXIM POLICY 2015-20)","address":"114 MARINE CHAMBERS ,,11 NEW MARIN E LINES ,MUMBAI,","city":"MAHARASHTRA,MAHARASHTRA","supplier":"HUNAN YUXIN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"SWATI SPENTOSE PRIVATE LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1900","totalValueFC":"19245.2","currency":"USD","unitRateINR":"158175","date":"12-Jul-2023","totalValueINR":"1581750.38","totalValueInUsd":"19245.2","indian_port":"BOMBAY AIR","hs_no":"29372900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"114 MARINE CHAMBERS ,,11 NEW MARIN E LINES ,MUMBAI,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700591400,"product":"DEFLAZACORT USDMF, PACKED IN: 0.25KG\/TIN\/CTN, CAS NO. 14484-47-0","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"TIANJIN TIANFA PHARMACEUTICALS IMP","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SUN PHARMACEUTICAL INDUSTRIES LTD","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"0.25","unit":"KGS","unitRateFc":"6400","totalValueFC":"1615.9","currency":"USD","unitRateINR":"538240","date":"22-Nov-2023","totalValueINR":"134560","totalValueInUsd":"1615.9","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"8888123","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"& EXP. CORP.109 BA WEI ROAD, HEDONGDISTRICT,TIANJIN 300 171, CHINASDNF CHINA","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736706600,"product":"DEFLAZACORT (PACKED IN 1 KG\/TIN\/CTN) DEFLAZACORT","address":"PLOT NO-2, SURVEY NO.93,SATYAM","city":"MANDAL, HYDERABAD, ANDHRA PRADESH","supplier":"TIANJIN TIANFA PHARMACEUTICALS IMP EXP CORP","supplierCountry":"CHINA","foreign_port":"SINGAPORE","customer":"APPCURE LABS PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"10000","totalValueFC":"10043","currency":"USD","unitRateINR":"866000","date":"13-Jan-2025","totalValueINR":"866000","totalValueInUsd":"10043","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"7756402","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SINGAPORE","supplierAddress":"109 BA WEI ROAD, HEDONG DISTRICT, T IANJIN SDNF CHINA","customerAddress":"PLOT NO-2, SURVEY NO.93,SATYAM"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741545000,"product":"(11B,16B) -11-HYDROXY-2-METHYL-5 H-PREGNA-1,4--DIENO (17,16-D) OXAZOLE-3.20-DIONE (DEFLAZACORT D5)(11B,16B) -11-HYDROXY-2-METHYL-5 H-PREGNA-1,4--DIENO (17,16-","address":"PLOT NO.1408-1409","city":"","supplier":"ZHEJIANG YOUSHENG INDUSTRY TRADE","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ABHILASHA PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"635","totalValueFC":"32183.4","currency":"USD","unitRateINR":"55753","date":"10-Mar-2025","totalValueINR":"2787650","totalValueInUsd":"32183.4","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"8804761","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"CO LTD25 JUYE ROAD HANGZHOU ZHEJIANG CHINA CHINA","customerAddress":"PLOT NO.1408-1409"}]
    31-Mar-2022
    01-May-2025
    KGS
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    Drugs in Development

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    Zydus Lifesciences Receives USFDA Approval for DMD Treatment Drug

    Details:

    Jaythari (deflazacort) is a corticosteroid, acts as glucocorticoid receptor agonist. It is approved for the treatment of duchenne muscular dystrophy in patients 5 years of age and older.


    Lead Product(s): Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: Jaythari

    Study Phase: Approved FDFProduct Type: Steroid

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 14, 2025

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    01

    Zydus Lifesciences

    India
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    Zydus Lifesciences

    India
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    Lead Product(s) : Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zydus Lifesciences Receives USFDA Approval for DMD Treatment Drug

    Details : Jaythari (deflazacort) is a corticosteroid, acts as glucocorticoid receptor agonist. It is approved for the treatment of duchenne muscular dystrophy in patients 5 years of age and older.

    Product Name : Jaythari

    Product Type : Steroid

    Upfront Cash : Inapplicable

    April 14, 2025

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    Cranbury Receives FDA Approval for First Generic Emflaza Oral Suspension

    Details:

    Emflaza-Generic (deflazacort) is a corticosteroid prodrug, which acts through the glucocorticoid receptor as an agonist. It is approved for the treatment of duchenne muscular dystrophy.


    Lead Product(s): Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: Emflaza-Generic

    Study Phase: Approved FDFProduct Type: Steroid

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 06, 2024

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    02

    Cranbury Pharmaceuticals

    U.S.A
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    IFT FIRST
    Not Confirmed

    Cranbury Pharmaceuticals

    U.S.A
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cranbury Receives FDA Approval for First Generic Emflaza Oral Suspension

    Details : Emflaza-Generic (deflazacort) is a corticosteroid prodrug, which acts through the glucocorticoid receptor as an agonist. It is approved for the treatment of duchenne muscular dystrophy.

    Product Name : Emflaza-Generic

    Product Type : Steroid

    Upfront Cash : Inapplicable

    December 06, 2024

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    Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablets in Multiple Strengths

    Details:

    Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.


    Lead Product(s): Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: Emflaza

    Study Phase: Approved FDFProduct Type: Steroid

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 02, 2024

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    03

    Aurobindo Pharma Limited

    India
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    IFT FIRST
    Not Confirmed

    Aurobindo Pharma Limited

    India
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aurobindo Pharma Receives USFDA Approval for Deflazacort Tablets in Multiple Strengths

    Details : Emflaza (deflazacort), a corticosteroid prodrug whose active metabolite acts as a glucocorticoid receptor agonist. It is approved for treating duchenne muscular dystrophy in patients 5 years & older.

    Product Name : Emflaza

    Product Type : Steroid

    Upfront Cash : Inapplicable

    December 02, 2024

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    FibroGen Announces Topline Results from LELANTOS-2, a Phase 3 Clinical Study of Pamrevlumab in Ambulatory Duchenne Muscular Dystrophy

    Details:

    FG-3019 (pamrevlumab) is a potential first-in-class antibody being developed to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders, which is investigated for the treatment of ambulatory patients with Duchenne muscular dystrophy.


    Lead Product(s): Pamrevlumab,Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: FG-3019

    Study Phase: Phase IIIProduct Type: Antibody

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 29, 2023

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    04

    FibroGen

    U.S.A
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    IFT FIRST
    Not Confirmed

    FibroGen

    U.S.A
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Pamrevlumab,Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FibroGen Announces Topline Results from LELANTOS-2, a Phase 3 Clinical Study of Pamrevlumab in Amb...

    Details : FG-3019 (pamrevlumab) is a potential first-in-class antibody being developed to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders, which is investigated for the treatment of ambulatory patients with Duchenne muscular d...

    Product Name : FG-3019

    Product Type : Antibody

    Upfront Cash : Inapplicable

    August 29, 2023

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    FibroGen Announces Topline Results from LELANTOS-1 Phase 3 Clinical Study of Pamrevlumab in Non-Ambulatory Patients with Duchenne Muscular Dystrophy

    Details:

    FG-3019 (pamrevlumab) is a potential first-in-class antibody being developed to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure.


    Lead Product(s): Pamrevlumab,Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: FG-3019

    Study Phase: Phase IIIProduct Type: Antibody

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 06, 2023

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    05

    FibroGen

    U.S.A
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    IFT FIRST
    Not Confirmed

    FibroGen

    U.S.A
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Pamrevlumab,Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FibroGen Announces Topline Results from LELANTOS-1 Phase 3 Clinical Study of Pamrevlumab in Non-Am...

    Details : FG-3019 (pamrevlumab) is a potential first-in-class antibody being developed to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction an...

    Product Name : FG-3019

    Product Type : Antibody

    Upfront Cash : Inapplicable

    July 06, 2023

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    FibroGen Announces Completion of Patient Enrollment in LELANTOS-2, a Phase 3 Clinical Study of Pamrevlumab in Duchenne Muscular Dystrophy

    Details:

    Pamrevlumab (FG-3019), is a potential antibody, have potential to inhibit the activity of connective tissue growth factor, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure.


    Lead Product(s): Pamrevlumab,Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: FG-3019

    Study Phase: Phase IIIProduct Type: Antibody

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 06, 2022

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    FibroGen

    U.S.A
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    IFT FIRST
    Not Confirmed

    FibroGen

    U.S.A
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    IFT FIRST
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    Lead Product(s) : Pamrevlumab,Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FibroGen Announces Completion of Patient Enrollment in LELANTOS-2, a Phase 3 Clinical Study of Pam...

    Details : Pamrevlumab (FG-3019), is a potential antibody, have potential to inhibit the activity of connective tissue growth factor, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ d...

    Product Name : FG-3019

    Product Type : Antibody

    Upfront Cash : Inapplicable

    August 06, 2022

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    FibroGen Receives Fast Track Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy

    Details:

    This designation follows review of the Phase 2 clinical data from a single-arm trial in non-ambulatory patients with DMD, and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.


    Lead Product(s): Pamrevlumab,Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: FG-3019

    Study Phase: Phase IIIProduct Type: Antibody

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 04, 2021

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    07

    FibroGen

    U.S.A
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    Not Confirmed

    FibroGen

    U.S.A
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Pamrevlumab,Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FibroGen Receives Fast Track Designation from the U.S. FDA for Pamrevlumab for the Treatment of Du...

    Details : This designation follows review of the Phase 2 clinical data from a single-arm trial in non-ambulatory patients with DMD, and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.

    Product Name : FG-3019

    Product Type : Antibody

    Upfront Cash : Inapplicable

    December 04, 2021

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    Results Add to Body of Evidence Confirming EMFLAZA®'s Benefit Over Prednisone

    Details:

    The results of this analysis adds to the body of evidence and clearly demonstrates the clinical benefit of EMFLAZA over prednisone. These results also reflect the benefit that patients experience in the real-world setting.


    Lead Product(s): Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: Emflaza

    Study Phase: Approved FDFProduct Type: Steroid

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 24, 2021

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    PTC Therapeutics

    U.S.A
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    IFT FIRST
    Not Confirmed

    PTC Therapeutics

    U.S.A
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    IFT FIRST
    Not Confirmed
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    Lead Product(s) : Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Results Add to Body of Evidence Confirming EMFLAZA®'s Benefit Over Prednisone

    Details : The results of this analysis adds to the body of evidence and clearly demonstrates the clinical benefit of EMFLAZA over prednisone. These results also reflect the benefit that patients experience in the real-world setting.

    Product Name : Emflaza

    Product Type : Steroid

    Upfront Cash : Inapplicable

    June 24, 2021

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    FibroGen Announces First Patient Enrolled in Pamrevlumab Phase 3 Clinical Trial in Patients with Duchenne Muscular Dystrophy

    Details:

    FibroGen has initiated LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD).


    Lead Product(s): Pamrevlumab,Deflazacort

    Therapeutic Area: Genetic Disease Brand Name: FG-3019

    Study Phase: Phase IIIProduct Type: Antibody

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 08, 2020

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    Lead Product(s) : Pamrevlumab,Deflazacort

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FibroGen Announces First Patient Enrolled in Pamrevlumab Phase 3 Clinical Trial in Patients with D...

    Details : FibroGen has initiated LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD).

    Product Name : FG-3019

    Product Type : Antibody

    Upfront Cash : Inapplicable

    November 08, 2020

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    INTERMEDIATE SUPPLIERS

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    Huvepharma Italia S.r.l

    Italy
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    Cortiseven

    CAS Number : 21269-13-6

    End Use API : Deflazacort

    About The Company : Huvepharma® Italia is a fast-growing global pharmaceutical company duly organized for developing, manufacturing and marketing advanced intermediates and active...

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    DOSAGE - TABLET;ORAL - 18MG

    USFDA APPLICATION NUMBER - 208684

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    DOSAGE - TABLET;ORAL - 30MG

    USFDA APPLICATION NUMBER - 208684

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    DOSAGE - TABLET;ORAL - 36MG

    USFDA APPLICATION NUMBER - 208684

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    DOSAGE - TABLET;ORAL - 6MG

    USFDA APPLICATION NUMBER - 208684

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    DOSAGE - SUSPENSION;ORAL - 22.75MG/ML

    USFDA APPLICATION NUMBER - 208685

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    ABOUT THIS PAGE

    Looking for 14484-47-0 / Deflazacort API manufacturers, exporters & distributors?

    Deflazacort manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Deflazacort API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Deflazacort manufacturer or Deflazacort supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deflazacort manufacturer or Deflazacort supplier.

    PharmaCompass also assists you with knowing the Deflazacort API Price utilized in the formulation of products. Deflazacort API Price is not always fixed or binding as the Deflazacort Price is obtained through a variety of data sources. The Deflazacort Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Deflazacort

    Synonyms

    14484-47-0, Azacort, Calcort, Oxazacort, Flantadin, Emflaza

    Cas Number

    14484-47-0

    Unique Ingredient Identifier (UNII)

    KR5YZ6AE4B

    About Deflazacort

    Deflazacort is a synthetic glucocorticoid prodrug, with anti-inflammatory and immunomodulating properties. Upon administration, the active metabolite of deflazacort, 21-desacetyl deflazacort, binds to and activates tissue glucocorticoid receptors. This results in the inhibition of specific leukocyte functions and the inhibition of proinflammatory cytokine production.

    Deflazacort Manufacturers

    A Deflazacort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deflazacort, including repackagers and relabelers. The FDA regulates Deflazacort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deflazacort API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Deflazacort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Deflazacort Suppliers

    A Deflazacort supplier is an individual or a company that provides Deflazacort active pharmaceutical ingredient (API) or Deflazacort finished formulations upon request. The Deflazacort suppliers may include Deflazacort API manufacturers, exporters, distributors and traders.

    click here to find a list of Deflazacort suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Deflazacort USDMF

    A Deflazacort DMF (Drug Master File) is a document detailing the whole manufacturing process of Deflazacort active pharmaceutical ingredient (API) in detail. Different forms of Deflazacort DMFs exist exist since differing nations have different regulations, such as Deflazacort USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Deflazacort DMF submitted to regulatory agencies in the US is known as a USDMF. Deflazacort USDMF includes data on Deflazacort's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deflazacort USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Deflazacort suppliers with USDMF on PharmaCompass.

    Deflazacort WC

    A Deflazacort written confirmation (Deflazacort WC) is an official document issued by a regulatory agency to a Deflazacort manufacturer, verifying that the manufacturing facility of a Deflazacort active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Deflazacort APIs or Deflazacort finished pharmaceutical products to another nation, regulatory agencies frequently require a Deflazacort WC (written confirmation) as part of the regulatory process.

    click here to find a list of Deflazacort suppliers with Written Confirmation (WC) on PharmaCompass.

    Deflazacort NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Deflazacort as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Deflazacort API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Deflazacort as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Deflazacort and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deflazacort NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Deflazacort suppliers with NDC on PharmaCompass.

    Deflazacort GMP

    Deflazacort Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Deflazacort GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Deflazacort GMP manufacturer or Deflazacort GMP API supplier for your needs.

    Deflazacort CoA

    A Deflazacort CoA (Certificate of Analysis) is a formal document that attests to Deflazacort's compliance with Deflazacort specifications and serves as a tool for batch-level quality control.

    Deflazacort CoA mostly includes findings from lab analyses of a specific batch. For each Deflazacort CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Deflazacort may be tested according to a variety of international standards, such as European Pharmacopoeia (Deflazacort EP), Deflazacort JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deflazacort USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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