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Bortezomib

Generic Name
Bortezomib
Brand Names
Velcade, Bortezomib Accord, Bortezomib Hospira, Bortezomib Fresenius Kabi, Bortezomib Sun
Drug Type
Small Molecule
Chemical Formula
C19H25BN4O4
CAS Number
179324-69-7
Unique Ingredient Identifier
69G8BD63PP

Overview

Bortezomib is a dipeptide boronic acid derivative and proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma. The 26S proteasome is a protein complex that degrades ubiquitinated proteins in the ubiquitin-proteasome pathway: reversible inhibition of the 26S proteasome, leading to cell cycle arrest and apoptosis of cancer cells, is thought to be the main mechanism of action of bortezomib. However, multiple mechanisms may be involved in the anticancer activity of bortezomib. Bortezomib was first synthesized in 1995. In May 2003, bortezomib became the first anticancer proteasome inhibitor that was approved by the FDA under the trade name VELCADE. Phase I, II, III, and IV clinical trials are undergoing to investigate the therapeutic efficacy of bortezomib in leukemia, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, and solid tumours.

Background

Bortezomib is a dipeptide boronic acid derivative and proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma. The 26S proteasome is a protein complex that degrades ubiquitinated proteins in the ubiquitin-proteasome pathway: reversible inhibition of the 26S proteasome, leading to cell cycle arrest and apoptosis of cancer cells, is thought to be the main mechanism of action of bortezomib. However, multiple mechanisms may be involved in the anticancer activity of bortezomib. Bortezomib was first synthesized in 1995. In May 2003, bortezomib became the first anticancer proteasome inhibitor that was approved by the FDA under the trade name VELCADE. Phase I, II, III, and IV clinical trials are undergoing to investigate the therapeutic efficacy of bortezomib in leukemia, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, and solid tumours.

Indication

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

Associated Conditions

  • Mantle Cell Lymphoma (MCL)
  • Multiple Myeloma (MM)

FDA Approved Products

bortezomib
Manufacturer:Hikma Pharmaceuticals USA Inc.
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:3.5 mg in 1 1
Approved: 2022/07/26
NDC:0143-9098
BORTEZOMIB
Manufacturer:Apotex Corp
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:3.5 mg in 1 1
Approved: 2024/03/20
NDC:60505-6050
VELCADE
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:3.5 mg in 1 1
Approved: 2022/08/31
NDC:63020-049
BORTEZOMIB
Manufacturer:Zydus Pharmaceuticals USA Inc.
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:1 mg in 1 mL
Approved: 2023/11/09
NDC:70710-1411
BORTEZOMIB
Manufacturer:Zydus Lifesciences Limited
Route:INTRAVENOUS, SUBCUTANEOUS
Strength:1 mg in 1 mL
Approved: 2022/05/05
NDC:70771-1708

Singapore Approved Products

BORTEZOMIB KABI POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL
Manufacturer:Fresenius Kabi Oncology Limited
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:3.5mg/vial
Online:Yes
Approved: 2022/04/08
Approval:SIN16472P
BORTESUN POWDER FOR SOLUTION FOR INJECTION 3.5 MG/ VIAL
Manufacturer:SUN PHARMACEUTICAL INDUSTRIES LIMITED
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:3.5mg/vial
Online:Yes
Approved: 2018/12/10
Approval:SIN15594P
VELTEZOM POWDER FOR SOLUTION FOR INJECTION 3.5MG
Manufacturer:oncomed manufacturing a.s. (Bulk production and primary packager)
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:3.5 mg/ vial
Online:Yes
Approved: 2022/01/26
Approval:SIN16421P
BORTEZOMIB-AFT POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL
Manufacturer:QILU PHARMACEUTICAL (HAINAN) CO LTD
Form:INJECTION, POWDER, FOR SOLUTION
Strength:3.5mg/vial
Online:Yes
Approved: 2022/09/01
Approval:SIN16586P
VELCADE 3.5mg FOR INJECTION
Manufacturer:BSP Pharmaceuticals S.p.A. (BSP), Fareva Pau (BULK MANUFACTURING AND PRIMARY PACKAGING)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:3.5mg
Online:Yes
Approved: 2005/03/15
Approval:SIN13064P

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