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Chemistry

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Also known as: 179324-69-7, Velcade, Ps-341, Ldp-341, Bortezomib (ps-341), Radiciol
Molecular Formula
C19H25BN4O4
Molecular Weight
384.2  g/mol
InChI Key
GXJABQQUPOEUTA-RDJZCZTQSA-N
FDA UNII
69G8BD63PP

Bortezomib
A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.
Bortezomib is a Proteasome Inhibitor. The mechanism of action of bortezomib is as a Proteasome Inhibitor.
1 2D Structure

Bortezomib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(1R)-3-methyl-1-[[(2S)-3-phenyl-2-(pyrazine-2-carbonylamino)propanoyl]amino]butyl]boronic acid
2.1.2 InChI
InChI=1S/C19H25BN4O4/c1-13(2)10-17(20(27)28)24-18(25)15(11-14-6-4-3-5-7-14)23-19(26)16-12-21-8-9-22-16/h3-9,12-13,15,17,27-28H,10-11H2,1-2H3,(H,23,26)(H,24,25)/t15-,17-/m0/s1
2.1.3 InChI Key
GXJABQQUPOEUTA-RDJZCZTQSA-N
2.1.4 Canonical SMILES
B(C(CC(C)C)NC(=O)C(CC1=CC=CC=C1)NC(=O)C2=NC=CN=C2)(O)O
2.1.5 Isomeric SMILES
B([C@H](CC(C)C)NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)C2=NC=CN=C2)(O)O
2.2 Other Identifiers
2.2.1 UNII
69G8BD63PP
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 341, Ps

2. Ldp 341

3. Ldp-341

4. Ldp341

5. Ps 341

6. Ps-341

7. Ps341

8. Velcade

2.3.2 Depositor-Supplied Synonyms

1. 179324-69-7

2. Velcade

3. Ps-341

4. Ldp-341

5. Bortezomib (ps-341)

6. Radiciol

7. Ps 341

8. ((r)-3-methyl-1-((s)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido)butyl)boronic Acid

9. Dpba

10. Ldp 341

11. Bortezomib Accord

12. Nsc-681239

13. [(1r)-3-methyl-1-[[(2s)-3-phenyl-2-(pyrazine-2-carbonylamino)propanoyl]amino]butyl]boronic Acid

14. Bortezomib (velcade)

15. N-[(1r)-1-(dihydroxyboryl)-3-methylbutyl]-n-(pyrazin-2-ylcarbonyl)-l-phenylalaninamide

16. Mln-341

17. [(1r)-3-methyl-1-[[(2s)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid

18. Mg 341

19. Mg-341

20. Boronic Acid, B-[(1r)-3-methyl-1-[[(2s)-1-oxo-3-phenyl-2-[(2-pyrazinylcarbonyl)amino]propyl]amino]butyl]-

21. Nsc 681239

22. 69g8bd63pp

23. Chembl325041

24. Peptide Boronate

25. Chebi:52717

26. Nsc681239

27. Ncgc00242506-02

28. S1013

29. Dsstox_cid_20980

30. Dsstox_rid_79609

31. N-[(1r)-1-(dihydroxyboranyl)-3-methylbutyl]-nalpha-(pyrazin-2-ylcarbonyl)-l-phenylalaninamide

32. Dsstox_gsid_40980

33. Pyz-phe-boroleu

34. (r)-3-methyl-1-((s)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido)butylboronic Acid

35. ((1r)-3-methyl-1-(((2s)-3-phenyl-2-((pyrazinylcarbonyl)amino)propanoyl)amino)butyl)boronic Acid

36. [(1r)-3-methyl-1-({(2s)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic Acid

37. Boronic Acid, ((1r)-3-methyl-1-(((2s)-1-oxo-3-phenyl-2-((pyrazinylcarbonyl)amino)propyl)amino)butyl)-

38. N-((1s)-1-benzyl-2-(((1r)-1-(dihydroxyboranyl)-3-methylbutyl)amino)-2-oxoethyl)pyrazinecarboxamide

39. Velcade (tn)

40. Cas-179324-69-7

41. Ps 341 (pharmaceutical)

42. Unii-69g8bd63pp

43. Brotezamide

44. Proscript Boronic Acid

45. Bortezomib [usan:inn:ban]

46. Hsdb 7666

47. Bortezomib Hydrate

48. Bortezomib,velcade

49. Lpd 341

50. Lpd-341

51. Ncgc00168751-01

52. Ncgc00181022-01

53. Bortezomib- Bio-x

54. Bortezomib [usan]

55. Mfcd09056737

56. Velcade (millenium)

57. 3mg0

58. Bortezomib [mi]

59. Bortezomib [inn]

60. Bortezomib [jan]

61. Bortezomib [hsdb]

62. Bortezomib [vandf]

63. Bortezomib [mart.]

64. Bortezomib [who-dd]

65. Mls004774142

66. Bortezomib (jan/usan/inn)

67. Bortezomib [ema Epar]

68. Schembl192129

69. Gtpl6391

70. Bortezomib [orange Book]

71. Bortezomib Hydrate [jan]

72. Dtxsid3040980

73. Tox21_112630

74. Tox21_112672

75. Bdbm50069989

76. Nsc756655

77. Akos015909706

78. Tox21_112672_1

79. Zinc169746649

80. Am81235

81. Ccg-268449

82. Cs-1039

83. Db00188

84. Nsc-756655

85. Bortezomib (velcade,mg-341,ps-341)

86. Ncgc00242506-01

87. Ncgc00242506-06

88. Ncgc00242506-07

89. As-15721

90. Bb164258

91. Hy-10227

92. Nci60_029010

93. Smr003500787

94. B5741

95. Sw208077-3

96. A18332

97. D03150

98. Ab01273951-01

99. Ab01273951-02

100. Ab01273951_03

101. 324b697

102. Q419319

103. Sr-01000939863

104. Sr-01000939863-2

105. Brd-k88510285-001-02-0

106. ((r)-3-methyl-1-((s)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido)butyl)boronicacid

107. (r)-3-methyl-1-((s)-3-phenyl-2-(pyrazine-6-carboxamido)propanamido)butylboronic Acid

108. (1r)-3-methyl-1-({(2s)-3-phenyl-2-[(2-pyrazinylcarbonyl)amino]propanoyl}amino)butylboronic Acid, Aldrichcpr

109. (r)-3-methyl-1-((s)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido)butan-2-ylboronic Acid

110. [(1r)-3-methyl-1-[[(2s)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]-butyl]boronic Acid

111. 1610526-91-4

112. Boronic Acid, (3-methyl-1-((1-oxo-3-phenyl-2-((pyrazinylcarbonyl)amino)propyl)amino)butyl)-, (s-(r*,s*))-

113. Boronic Acid, [(1(r)-3-methyl-1-[[(2s)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]-

114. N-((1s)-1-benzyl-2-(((1r)-1-(dihydroxyboranyl)-3-methylbutyl)amino)2-oxoethylpyrazinecarboxamide

115. N-[(1r)-1-(dihydroxyboranyl)-3-methylbutyl]-n(alpha)-(pyrazin-2-ylcarbonyl)-l-phenylalaninamide

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 384.2 g/mol
Molecular Formula C19H25BN4O4
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count9
Exact Mass384.1968855 g/mol
Monoisotopic Mass384.1968855 g/mol
Topological Polar Surface Area124 Ų
Heavy Atom Count28
Formal Charge0
Complexity500
Isotope Atom Count0
Defined Atom Stereocenter Count2
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 2  
Drug NameVelcade
PubMed HealthBortezomib (Injection)
Drug ClassesAntineoplastic Agent
Drug LabelVELCADE (bortezomib) for Injection is an antineoplastic agent available for intravenous injection or subcutaneous use. Each single use vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. Inactive ingredient: 35 mg mannitol, USP.Bort...
Active IngredientBortezomib
Dosage FormInjectable
RouteIntravenous, subcutaneous
Strength3.5mg/vial
Market StatusPrescription
CompanyMillennium Pharms

2 of 2  
Drug NameVelcade
PubMed HealthBortezomib (Injection)
Drug ClassesAntineoplastic Agent
Drug LabelVELCADE (bortezomib) for Injection is an antineoplastic agent available for intravenous injection or subcutaneous use. Each single use vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. Inactive ingredient: 35 mg mannitol, USP.Bort...
Active IngredientBortezomib
Dosage FormInjectable
RouteIntravenous, subcutaneous
Strength3.5mg/vial
Market StatusPrescription
CompanyMillennium Pharms

4.2 Therapeutic Uses

Antineoplastic Agents; Protease Inhibitors

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


Bortezomib injection is indicated for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for Velcade (Bortezomib) (January 2008). Available from, as of November 25, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6358


Bortezomib injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for Velcade (Bortezomib) (January 2008). Available from, as of November 25, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6358


4.3 Drug Warning

Known hypersensitivity to bortezomib, boron, or mannitol.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 929


Bortezomib mainly causes sensory peripheral neuropathy, but severe motor peripheral neuropathy also has been reported. In the phase III trial, peripheral neuropathy occurred in 36% of patients receiving bortezomib and 9% of patients receiving dexamethasone. Grade 3 or 4 peripheral neuropathy occurred in 7 or less than 1%, respectively, of patients receiving bortezomib. Following dosage adjustments, amelioration or resolution of peripheral neuropathy was reported in 51% of patients with grade 2 or higher peripheral neuropathy within a median of 3.5 months from onset. About 8% of patients discontinued bortezomib therapy because of peripheral neuropathy.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 929


Patients receiving bortezomib should be monitored for manifestations of neuropathy (eg, burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain). Dose and/or frequency of administration of bortezomib should be adjusted in patients who experience new-onset or exacerbation of peripheral neuropathy.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 929


In the phase III trial, asthenia (ie, fatigue, malaise, weakness) was reported in 61% of patients receiving bortezomib and 45% of patients receiving dexamethasone. Grade 3 asthenia occurred in 12 versus 6%, respectively, of patients receiving bortezomib or dexamethasone. About 3% of patients receiving bortezomib and 2% of patients receiving dexamethasone discontinued therapy because of asthenia.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 929


For more Drug Warnings (Complete) data for BORTEZOMIB (26 total), please visit the HSDB record page.


4.4 Drug Indication

Bortezomib is indicated for the treatment of adult patients with multiple myeloma or mantle cell lymphoma.


FDA Label


Velcade as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.

Velcade in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation.

Velcade in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.

Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.


Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.

Bortezomib Hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib Hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib Hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.


Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.

Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.


Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.

Bortezomib SUN in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.


Bortezomib Accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.

Bortezomib Accord in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for highdose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib Accord in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for highdose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib Accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.


Treatment of mantle cell lymphoma


5 Pharmacology and Biochemistry
5.1 Pharmacology

Bortezomib works to target the ubiquitin-proteasome pathway, an essential molecular pathway that regulates intracellular concentrations of proteins and promotes protein degradation. The ubiquitin-proteasome pathway is often dysregulated in pathological conditions, leading to aberrant pathway signalling and the formation of malignant cells. In one study, patient-derived chronic lymphocytic leukemia (CLL) cells contained 3-fold higher levels of chymotrypsin-like proteasome activity than normal lymphocytes. By reversibly inhibiting proteasome, bortezomib prevents proteasome-mediated proteolysis. Bortezomib exerts a cytotoxic effect on various cancer cell types _in vitro_ and delays tumour growth _in vivo_ in nonclinical tumour models. Bortezomib inhibits the proteasome activity in a dose-dependent manner. In one pharmacodynamic study, more than 75% of proteasome inhibition was observed in whole blood samples within one hour after dosing of bortezomib.


5.2 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
BORTEZOMIB
5.3.2 FDA UNII
69G8BD63PP
5.3.3 Pharmacological Classes
Proteasome Inhibitors [MoA]; Proteasome Inhibitor [EPC]
5.4 ATC Code

L01XG01


L01XG01


L01XG01


L01XG01


L01XX32


L01XX32

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


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01X - Other antineoplastic agents

L01XG - Proteasome inhibitors

L01XG01 - Bortezomib


5.5 Absorption, Distribution and Excretion

Absorption

Following intravenous administration of 1 mg/m2 and 1.3 mg/m2 doses, the mean Cmax of bortezomib were 57 and 112 ng/mL, respectively. In a twice-weekly dosing regimen, the Cmax ranged from 67 to 106 ng/mL at the dose of 1 mg/m2 and 89 to 120 ng/mL for the 1.3 mg/m2 dose. In patients with multiple myeloma, the Cmax of bortezomib followig subcutaneous administration was lower than that of intravenously-administered dose; however, the total systemic exposure of the drug was equivalent for both routes of administration. There is a wide interpatient variability in drug plasma concentrations.


Route of Elimination

Bortezomib is eliminated by both renal and hepatic routes.


Volume of Distribution

The mean distribution volume of bortezomib ranged from approximately 498 to 1884 L/m2 in patients with multiple myeloma receiving a single- or repeat-dose of 1 mg/m2 or 1.3 mg/m2. Bortezomib distributes into nearly all tissues, except for the adipose and brain tissue.


Clearance

Following the administration of a first dose of 1 mg/m2 and 1.3 mg/m2, the mean mean total body clearances were 102 and 112 L/h, respectively. The clearances were 15 and 32 L/h after the subsequent dose of 1 and 1.3 mg/m2, respectively.


Following intravenous administration of 1 mg/sq m and 1.3 mg/sq m doses to 24 patients with multiple myeloma (n=12, per each dose level), the mean maximum plasma concentrations of bortezomib (Cmax) after the first dose (Day 1) were 57 and 112 ng/mL, respectively.

US Natl Inst Health; DailyMed. Current Medication Information for Velcade (Bortezomib) (January 2008). Available from, as of November 25, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6358


In subsequent doses, when administered twice weekly, the mean maximum observed plasma concentrations ranged from 67 to 106 ng/mL for the 1 mg/sq m dose and 89 to 120 ng/mL for the 1.3 mg/sq m dose. The mean elimination half-life of bortezomib upon multiple dosing ranged from 40 to 193 hours after the 1 mg/sq m dose and 76 to 108 hours after the 1.3 mg/sq m dose. The mean total body clearances was 102 and 112 L/hr following the first dose for doses of 1 mg/sq m and 1.3 mg/sq m, respectively, and ranged from 15 to 32 L/hr following subsequent doses for doses of 1 and 1.3 mg/sq m, respectively.

US Natl Inst Health; DailyMed. Current Medication Information for Velcade (Bortezomib) (January 2008). Available from, as of November 25, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6358


The mean distribution volume of bortezomib ranged from approximately 498 to 1884 L/sq m following single- or repeat-dose administration of 1 mg/sq m or 1.3mg/sq m to patients with multiple myeloma. This suggests bortezomib distributes widely to peripheral tissues. The binding of bortezomib to human plasma proteins averaged 83% over the concentration range of 100 to 1000 ng/mL.

US Natl Inst Health; DailyMed. Current Medication Information for Velcade (Bortezomib) (January 2008). Available from, as of November 25, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6358


It is not known whether bortezomib is excreted in human milk.

US Natl Inst Health; DailyMed. Current Medication Information for Velcade (Bortezomib) (January 2008). Available from, as of November 25, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6358


For more Absorption, Distribution and Excretion (Complete) data for BORTEZOMIB (6 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Bortezomib is primarily metabolized by CYP3A4, CYP2C19, and CYP1A2. CYP2D6 and CYP2C9 are also involved in drug metabolism, but to a smaller extent. Oxidative deboronation, which involves the removal of boronic acid from the parent compound, is the main metabolic pathway. Metabolites of bortezomib are pharmacologically inactive and more than 30 metabolites have been identified in human and animal studies.


In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolized via cytochrome P450 enzymes 3A4, 2C19, and 1A2. Bortezomib metabolism by CYP 2D6 and 2C9 enzymes is minor. The major metabolic pathway is deboronation to form 2 deboronated metabolites that subsequently undergo hydroxylation to several metabolites. Deboronated bortezomib metabolites are inactive as 26S proteasome inhibitors. Pooled plasma data from 8 patients at 10 min and 30 min after dosing indicate that the plasma levels of metabolites are low compared to the parent drug.

US Natl Inst Health; DailyMed. Current Medication Information for Velcade (Bortezomib) (January 2008). Available from, as of November 25, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6358


... The P450 inhibition potential of bortezomib and its major deboronated metabolites M1 and M2 and their dealkylated metabolites M3 and M4 was evaluated in human liver microsomes for the major P450 isoforms 1A2, 2C9, 2C19, 2D6, and 3A4/5. Bortezomib, M1, and M2 were found to be mild inhibitors of CYP2C19 (IC(50) approximately 18.0, 10.0, and 13.2 microM, respectively), and M1 was also a mild inhibitor of CYP2C9 (IC(50) approximately 11.5 microM). However, bortezomib, M1, M2, M3, and M4 did not inhibit other P450s (IC(50) values > 30 microM). There also was no time-dependent inhibition of CYP3A4/5 by bortezomib or its major metabolites. ...

PMID:16443666 LU C et al; Drug Metab Dispos 34 (4): 702-8 (2006)


... Bortezomib binds the proteasome via the boronic acid moiety, and therefore, the presence of this moiety is necessary to achieve proteasome inhibition. Metabolites in plasma obtained from patients receiving a single intravenous dose of bortezomib were identified and characterized by liquid chromatography/mass spectrometry (LC/MS) and liquid chromatography/tandem mass spectrometry (LC/MS/MS). Metabolite standards that were synthesized and characterized by LC/MS/MS and high field nuclear magnetic resonance spectroscopy (NMR) were used to confirm metabolite structures. The principal biotransformation pathway observed was oxidative deboronation, most notably to a pair of diastereomeric carbinolamide metabolites. Further metabolism of the leucine and phenylalanine moieties produced tertiary hydroxylated metabolites and a metabolite hydroxylated at the benzylic position, respectively. Conversion of the carbinolamides to the corresponding amide and carboxylic acid was also observed. Human liver microsomes adequately modeled the in vivo metabolism of bortezomib, as the principal circulating metabolites were observed in vitro. Using cDNA-expressed cytochrome P450 isoenzymes, it was determined that several isoforms contributed to the metabolism of bortezomib, including CYP3A4, CYP2C19, CYP1A2, CYP2D6, and CYP2C9. ...

PMID:15764713 Pekol T et al; Drug Metab Dispos 33 (6): 771-7 (2005)


5.7 Biological Half-Life

The mean elimination half-life of bortezomib ranged from 40 to 193 hours following a multiple dosing regimen at a 1 mg/m2 dose. The half-life ranged from 76 to 108 hours after multiple dosing of 1.3 mg/m2 bortezomib.


The mean elimination half-life of bortezomib upon multiple dosing ranged from 40 to 193 hours after the 1 mg/sq m dose and 76 to 108 hours after the 1.3 mg/sq m dose.

US Natl Inst Health; DailyMed. Current Medication Information for Velcade (Bortezomib) (January 2008). Available from, as of November 25, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6358


5.8 Mechanism of Action

The ubiquitin-proteasome pathway is a homeostatic proteolytic pathway for intracellular protein degradation: proteins marked with a poly-ubiquitin chain are degraded to small peptides and free ubiquitin by the proteasome, which is a large multimeric protease. Aberrant proteasome-dependent proteolysis, as seen in some malignancies, can lead to uncontrolled cell division, leading to tumorigenesis, cancer growth, and spread. Bortezomib is a reversible inhibitor of the 26S proteasome, which is made up of a 20S core complexed with a 19S regulatory complex. Individual -subunits allow specific catalytic action of the 20S core. In mammalian cells, bortezomib is a potent inhibitor of the proteasomes chymotryptic-like activity, which is attributed to the 5-subunit of the 20S core particle. Bortezomib binds to the active site of the threonine hydroxyl group in the 5-subunit. A probing study showed bortezomib also binding to and inhibiting the 1-subunit, which mediates the caspase-like activity of the proteasome, and 1i-subunit, which is an altered subunit that is expressed to form immunoproteasomes in response to cell stress or inflammation. By inhibiting the proteasome-mediated degradation of key proteins that promote cell apoptosis, bortezomib induces a cell cycle arrest during the G2-M phase. It is believed that multiple mechanisms, other than proteasome inhibition, may be involved in the anticancer activity of bortezomib. The anticancer activity of bortezomib was largely associated with suppression of the NF-B signalling pathway, resulting in the downregulation of anti-apoptotic target genes and expression of anti-apoptic proteins. This may be explained by bortezomib preventing uncontrolled degradation of IB, which is an inhibitory protein of NF-B. NOXA, which is a pro-apoptotic factor, induced by bortezomib selectively in cancer cells; thus, it is suggested to be another key mechanism of bortezomib.


Bortezomib, a modified dipeptidyl boronic acid, is an antineoplastic agent. The drug reversibly inhibits the 26S proteasome, a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome pathway plays an essential role in regulating the intracellular concentration of specific proteins, thereby maintaining homeostasis within cells. Inhibition of the 26S proteasome by bortezomib prevents targeted proteolysis and causes disruption of normal homeostatic mechanisms, which can lead to cell death. In vitro studies indicate that bortezomib is cytotoxic to a variety of cancer cell types. Bortezomib has been shown to cause a delay in tumor growth in vivo in tumor models, including multiple myeloma.

American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008, p. 931


... The mechanisms underlying /bortezomib/ cancer cell toxicity are complex. A growing body of evidence suggests proteasome inhibition-dependent regulation of the BCL-2 family is a critical requirement. In particular, the stabilization of BH3-only proteins BIK, NOXA and BIM, appear to be essential for effecting BAX- and BAK-dependent cell death. ...

PMID:17828309 Fennell DA et al; Oncogene 27 (9): 1189-97 (2008)


Proteasome inhibition is a novel, targeted approach in cancer therapy. Both natural and synthetic proteasome inhibitors selectively penetrate cancer cells, disrupting the orderly destruction of key regulatory proteins involved in tumorigenesis and metastasis. Disrupting the orderly destruction of regulatory proteins causes an imbalance of these proteins within the cell, which interferes with the systematic activation of signaling pathways required to maintain tumor cell growth and survival; therefore, cellular replication is inhibited and apoptosis ensues. ...

PMID:15688597 Jung L et al; Oncology (Williston Park) 18 (14 Suppl 11): 4-13 (2004)


Bortezomib (PS-341, Velcade) is a potent and selective inhibitor of the proteasome that is currently under investigation for the treatment of solid malignancies. /Investigators/ have shown previously that bortezomib has activity in pancreatic cancer models and that the drug induces endoplasmic reticulum (ER) stress but also suppresses the unfolded protein response (UPR). Because the UPR is an important cytoprotective mechanism, /investigators/ hypothesized that bortezomib would sensitize pancreatic cancer cells to ER stress-mediated apoptosis. Here, /the authors/ show that bortezomib promotes apoptosis triggered by classic ER stress inducers (tunicamycin and thapsigargin) via a c-Jun NH(2)-terminal kinase (JNK)-dependent mechanism. /They/ also show that cisplatin stimulates ER stress and interacts with bortezomib to increase ER dilation, intracellular Ca(2+) levels, and cell death. Importantly, combined therapy with bortezomib plus cisplatin induced JNK activation and apoptosis in orthotopic pancreatic tumors resulting in a reduction in tumor burden. Taken together, the data establish that bortezomib sensitizes pancreatic cancer cells to ER stress-induced apoptosis and show that bortezomib strongly enhances the anticancer activity of cisplatin.

PMID:16357177 Nawrocki ST et al; Cancer Res 65 (24): 11658-66 (2005)


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29-Mar-2021
26-Oct-2024
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.


Lead Product(s): Isatuximab,Bortezomib,Lenalidomide

Therapeutic Area: Oncology Brand Name: Sarclisa

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 14, 2024

Sanofi Company Banner

01

Sanofi

France
arrow
Antibody Engineering
Not Confirmed

Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide

Therapeutic Area : Oncology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.

Brand Name : Sarclisa

Molecule Type : Large molecule

Upfront Cash : Not Applicable

November 14, 2024

Sanofi Company Banner

Details:

Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.


Lead Product(s): Isatuximab,Bortezomib,Lenalidomide

Therapeutic Area: Oncology Brand Name: Sarclisa

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 21, 2024

Sanofi Company Banner

02

Sanofi

France
arrow
Antibody Engineering
Not Confirmed

Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide

Therapeutic Area : Oncology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.

Brand Name : Sarclisa

Molecule Type : Large molecule

Upfront Cash : Not Applicable

September 21, 2024

Sanofi Company Banner

Details:

Sarclisa (isatuximab) will be the first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.


Lead Product(s): Isatuximab,Bortezomib,Lenalidomide

Therapeutic Area: Oncology Brand Name: Sarclisa

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 08, 2024

Sanofi Company Banner

03

Sanofi

France
arrow
Antibody Engineering
Not Confirmed

Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Sarclisa (isatuximab) will be the first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.

Brand Name : Sarclisa

Molecule Type : Large molecule

Upfront Cash : Not Applicable

August 08, 2024

Sanofi Company Banner

Details:

Sarclisa (isatuximab) will be the first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.


Lead Product(s): Isatuximab,Bortezomib,Lenalidomide

Therapeutic Area: Oncology Brand Name: Sarclisa

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2024

Sanofi Company Banner

04

Sanofi

France
arrow
Antibody Engineering
Not Confirmed

Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Sarclisa (isatuximab) will be the first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.

Brand Name : Sarclisa

Molecule Type : Large molecule

Upfront Cash : Not Applicable

May 27, 2024

Sanofi Company Banner

Details:

Sarclisa (isatuximab) is a CD38 monoclonal antibody in combination with standard-of-care bortezomib, lenalidomide and dexamethasone is being evaluated in newly diagnosed multiple myeloma not eligible for transplant.


Lead Product(s): Isatuximab,Lenalidomide,Bortezomib

Therapeutic Area: Oncology Brand Name: Sarclisa

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 08, 2023

Sanofi Company Banner

05

Sanofi

France
arrow
Antibody Engineering
Not Confirmed

Lead Product(s) : Isatuximab,Lenalidomide,Bortezomib

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Sarclisa (isatuximab) is a CD38 monoclonal antibody in combination with standard-of-care bortezomib, lenalidomide and dexamethasone is being evaluated in newly diagnosed multiple myeloma not eligible for transplant.

Brand Name : Sarclisa

Molecule Type : Large molecule

Upfront Cash : Not Applicable

December 08, 2023

Sanofi Company Banner

Details:

Launch of Bortezomib for Injection 3.5 mg, the generic equivalent of Velcade® (bortezomib) Injection, in the U.S. market approved by the U.S. Food and Drug Administration, used to treat multiple myeloma and mantle cell lymphoma.


Lead Product(s): Bortezomib

Therapeutic Area: Oncology Brand Name: Bortezomib-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2022

Dr Reddy Company Banner

06

Antibody Engineering
Not Confirmed

Lead Product(s) : Bortezomib

Therapeutic Area : Oncology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Launch of Bortezomib for Injection 3.5 mg, the generic equivalent of Velcade® (bortezomib) Injection, in the U.S. market approved by the U.S. Food and Drug Administration, used to treat multiple myeloma and mantle cell lymphoma.

Brand Name : Bortezomib-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 27, 2022

Dr Reddy Company Banner

Details:

Bortezomib EVER Pharma is a proteasome inhibitor small molecule drug candidate, which is indicated for the treatment of patients with multiple myeloma and mantle cell lymphoma.


Lead Product(s): Bortezomib

Therapeutic Area: Oncology Brand Name: Bortezomib EVER Pharma

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 09, 2022

Ever Pharma CB

07

Ever Pharma

Austria
arrow
Antibody Engineering
Not Confirmed

Lead Product(s) : Bortezomib

Therapeutic Area : Oncology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Bortezomib EVER Pharma is a proteasome inhibitor small molecule drug candidate, which is indicated for the treatment of patients with multiple myeloma and mantle cell lymphoma.

Brand Name : Bortezomib EVER Pharma

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 09, 2022

Ever Pharma CB
  • Development Update

Details:

Blenrep (belantamab mafodotin-blmf) is an anti-BCMA ADC. It is being evaluated in combination with pomalidomide, bortezomib and dexamethasone for the treatment of relapsed/refractory multiple myeloma.


Lead Product(s): Belantamab Mafodotin,Bortezomib,Dexamethasone

Therapeutic Area: Oncology Brand Name: Blenrep

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 14, 2024

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08

GSK

United Kingdom
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Antibody Engineering
Not Confirmed

GSK

United Kingdom
arrow
Antibody Engineering
Not Confirmed

Lead Product(s) : Belantamab Mafodotin,Bortezomib,Dexamethasone

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Blenrep (belantamab mafodotin-blmf) is an anti-BCMA ADC. It is being evaluated in combination with pomalidomide, bortezomib and dexamethasone for the treatment of relapsed/refractory multiple myeloma.

Brand Name : Blenrep

Molecule Type : Large molecule

Upfront Cash : Not Applicable

November 14, 2024

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Details:

Darzalex (daratumumab) a CD38 inhibitor, being evaluated in combination with bortezomib, lenalidomide, dexamethasone for the treatment of newly diagnosed multiple myeloma.


Lead Product(s): Daratumumab,Lenalidomide,Bortezomib

Therapeutic Area: Oncology Brand Name: Darzalex

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 23, 2024

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09

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Darzalex (daratumumab) a CD38 inhibitor, being evaluated in combination with bortezomib, lenalidomide, dexamethasone for the treatment of newly diagnosed multiple myeloma.

Brand Name : Darzalex

Molecule Type : Large molecule

Upfront Cash : Not Applicable

October 23, 2024

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Details:

XPOVIO (selinexor) approved for adult patients with multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone.


Lead Product(s): Selinexor,Bortezomib,Dexamethasone

Therapeutic Area: Oncology Brand Name: Xpovio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 17, 2024

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10

Antengene

China
arrow
Antibody Engineering
Not Confirmed

Antengene

China
arrow
Antibody Engineering
Not Confirmed

Details : XPOVIO (selinexor) approved for adult patients with multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone.

Brand Name : Xpovio

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 17, 2024

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FDF Dossiers

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01

Sanofi

France
arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Bortezomibum

Brand Name : Bortezomib Zentiva

Dosage Form : Dry Sub

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

Sanofi

France
arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Bortezomibum

Brand Name : Bortezomib Zentiva

Dosage Form : Dry Sub

Dosage Strength : 3.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

03

arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Packaging :

Approval Date : 2022-07-26

Application Number : 202963

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

04

arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : DISCN

Registration Country : USA

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : 3.5MG/VIAL

Packaging :

Approval Date : 2019-10-04

Application Number : 206927

Regulatory Info : DISCN

Registration Country : USA

Dr Reddy Company Banner

05

arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Bortezomib

Brand Name :

Dosage Form : Injection

Dosage Strength : 3.5MG/VIAL

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

06

arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Approved in both US & EU

Registration Country : India

Bortezomib

Brand Name :

Dosage Form : Injection

Dosage Strength : 3.5MG/VIAL

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Approved in both US & EU

Registration Country : India

Dr Reddy Company Banner

07

arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

Flag Poland
Digital Content Digital Content

Regulatory Info : Dossier Available

Registration Country : Poland

Bortezomib

Brand Name :

Dosage Form : Powder for Solution for Injection

Dosage Strength : 3.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Available

Registration Country : Poland

Polfa Tarchomin

08

NanoAlvand

Iran
arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Flag Iran
Digital Content Digital Content

Regulatory Info :

Registration Country : Iran

Bortezomib

Brand Name : Alvocade

Dosage Form : Vial

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

NanoAlvand

09

NanoAlvand

Iran
arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Flag Iran
Digital Content Digital Content

Regulatory Info :

Registration Country : Iran

Bortezomib

Brand Name : Alvocade

Dosage Form : Vial

Dosage Strength : 3.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

NanoAlvand

10

arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Bortezomib

Brand Name :

Dosage Form : Lyophilized Powder for Injection

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya
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FDA Orange Book

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01

DR REDDYS

India
arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

RLD : No

TE Code : AP

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2022-07-26

Application Number : 202963

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

02

DR REDDYS

India
arrow
AES 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

RLD : No

TE Code :

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2019-10-04

Application Number : 206927

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

03

APOTEX

Canada
AES 2024
Not Confirmed
arrow

APOTEX

Canada
arrow
AES 2024
Not Confirmed

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2022-05-02

Application Number : 205533

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

AES 2024
Not Confirmed
arrow
arrow
AES 2024
Not Confirmed

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2022-05-02

Application Number : 213823

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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05

AES 2024
Not Confirmed
arrow
arrow
AES 2024
Not Confirmed

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2022-05-02

Application Number : 209659

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

AES 2024
Not Confirmed
arrow
arrow
AES 2024
Not Confirmed

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2022-07-26

Application Number : 215011

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

HOSPIRA

U.S.A
AES 2024
Not Confirmed
arrow

HOSPIRA

U.S.A
arrow
AES 2024
Not Confirmed

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : POWDER;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 2.5MG/VIAL

Approval Date : 2022-05-02

Application Number : 209191

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

MEITHEAL

U.S.A
AES 2024
Not Confirmed
arrow

MEITHEAL

U.S.A
arrow
AES 2024
Not Confirmed

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2022-07-26

Application Number : 212958

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

MSN

India
AES 2024
Not Confirmed
arrow

MSN

India
arrow
AES 2024
Not Confirmed

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2022-07-26

Application Number : 209622

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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10

AES 2024
Not Confirmed
arrow
arrow
AES 2024
Not Confirmed

BORTEZOMIB

Brand Name : BORTEZOMIB

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 3.5MG/VIAL

Approval Date : 2022-05-02

Application Number : 205857

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Europe

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01

Helvepharm AG

France
arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Bortezomibum

Brand Name : Bortezomib Zentiva

Dosage Form : Dry Sub

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

Helvepharm AG

France
arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Bortezomibum

Brand Name : Bortezomib Zentiva

Dosage Form : Dry Sub

Dosage Strength : 3.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

03

Accord Healthcare Ltd.

United Kingdom
Antibody Engineering
Not Confirmed
arrow

Accord Healthcare Ltd.

United Kingdom
arrow
Antibody Engineering
Not Confirmed

bortezomib

Brand Name : bortezomib Accord

Dosage Form : POWDER FOR SOLUTION FOR INJECTION

Dosage Strength : 3.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

04

Accord Healthcare AG

United Kingdom
Antibody Engineering
Not Confirmed
arrow

Accord Healthcare AG

United Kingdom
arrow
Antibody Engineering
Not Confirmed

Bortezomibum

Brand Name : Bortezomib Accord

Dosage Form : Dry Sub

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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05

Accord Healthcare AG

United Kingdom
Antibody Engineering
Not Confirmed
arrow

Accord Healthcare AG

United Kingdom
arrow
Antibody Engineering
Not Confirmed

Bortezomibum

Brand Name : Bortezomib Accord

Dosage Form : Dry Sub

Dosage Strength : 3.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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06

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

bortezomib

Brand Name : VELCADE

Dosage Form : PULVER TILL INJEKTIONSVÄTSKA, LÖSNING

Dosage Strength : 1 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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07

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

Bortezomib

Brand Name : Velcade

Dosage Form : Powder for injection fluid, resolution

Dosage Strength : 3.5 mg

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

Bortezomibum

Brand Name : Velcade

Dosage Form : Dry Sub

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Sandoz A / S,

Switzerland
Antibody Engineering
Not Confirmed
arrow

Sandoz A / S,

Switzerland
arrow
Antibody Engineering
Not Confirmed

bortezomib

Brand Name : bortezomib Sandoz

Dosage Form : POWDER FOR SOLUTION FOR INJECTION

Dosage Strength : 3.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

Bortezomibum

Brand Name : Bortezomib Sandoz

Dosage Form : Dry Sub

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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01

APOTEX INC

Canada
Antibody Engineering
Not Confirmed
arrow

APOTEX INC

Canada
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : BORTEZOMIB

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3.5MG/VIAL

Packaging : 10ML

Approval Date :

Application Number : 2456176

Regulatory Info : Prescription

Registration Country : Canada

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02

JANSSEN INC

U.S.A
Antibody Engineering
Not Confirmed
arrow

JANSSEN INC

U.S.A
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : VELCADE

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3.5MG/VIAL

Packaging : 10 ML

Approval Date :

Application Number : 2262452

Regulatory Info : Prescription

Registration Country : Canada

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03

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : BORTEZOMIB FOR INJECTION

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3.5MG/VIAL

Packaging :

Approval Date :

Application Number : 2493306

Regulatory Info : Prescription

Registration Country : Canada

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04

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : BORTEZOMIB FOR INJECTION

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 2.5MG/VIAL

Packaging : 10ML VIAL

Approval Date :

Application Number : 2467003

Regulatory Info : Prescription

Registration Country : Canada

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05

Antibody Engineering
Not Confirmed
arrow
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Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : PMS-BORTEZOMIB

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3.5MG/VIAL

Packaging :

Approval Date :

Application Number : 2466708

Regulatory Info : Prescription

Registration Country : Canada

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06

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : BORTEZOMIB FOR INJECTION SDZ

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3.5MG/VIAL

Packaging :

Approval Date :

Application Number : 2503352

Regulatory Info : Prescription

Registration Country : Canada

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07

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : TARO-BORTEZOMIB

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 2.5MG/VIAL

Packaging :

Approval Date :

Application Number : 2511932

Regulatory Info : Prescription

Registration Country : Canada

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08

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : BORTEZOMIB FOR INJECTION

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3.5MG/VIAL

Packaging : I.V.:3.5ML/S.C:1.4ML

Approval Date :

Application Number : 2423405

Regulatory Info : Prescription

Registration Country : Canada

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09

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : ACT BORTEZOMIB

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3.5MG/VIAL

Packaging :

Approval Date :

Application Number : 2438399

Regulatory Info : Prescription

Registration Country : Canada

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10

DR REDDY'S LABORATORIES LTD

Country
Antibody Engineering
Not Confirmed
arrow

DR REDDY'S LABORATORIES LTD

Country
arrow
Antibody Engineering
Not Confirmed

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Brand Name : BORTEZOMIB FOR INJECTION

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 3.5MG/VIAL

Packaging : SC: 1.4ML (2.5MG/ML) / IV: 3.5ML (1MG/ML)

Approval Date :

Application Number : 2452456

Regulatory Info : Prescription

Registration Country : Canada

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