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)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/01 | Not Applicable | Not yet recruiting | PETHEMA Foundation | ||
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/06/06 | Phase 1 | Not yet recruiting | |||
2025/05/04 | Phase 3 | Active, not recruiting | |||
2025/04/09 | Phase 3 | Not yet recruiting | |||
2025/03/28 | Phase 1 | Recruiting | Sun Yat-sen University | ||
2025/03/11 | Phase 3 | Active, not recruiting | |||
2025/03/11 | Phase 3 | Active, not recruiting | |||
2025/02/28 | Phase 2 | Active, not recruiting | |||
2024/10/24 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | 71288-118 | INTRAVENOUS, SUBCUTANEOUS | 3.5 mg in 1 1 | 7/26/2022 | |
| MAIA Pharmaceuticals, Inc. | 70511-161 | INTRAVENOUS | 1 mg in 1 1 | 8/10/2022 | |
| Sagent Pharmaceuticals | 25021-262 | INTRAVENOUS, SUBCUTANEOUS | 3.5 mg in 1 1 | 5/5/2025 | |
| Hospira, Inc. | 0409-1700 | INTRAVENOUS, SUBCUTANEOUS | 3.5 mg in 1 1 | 7/25/2022 | |
| BluePoint Laboratories | 68001-540 | INTRAVENOUS, SUBCUTANEOUS | 3.5 mg in 1 1 | 5/16/2022 | |
| BluePoint Laboratories | 68001-541 | INTRAVENOUS, SUBCUTANEOUS | 3.5 mg in 3.5 mL | 8/16/2022 | |
| Eugia US LLC | 55150-337 | INTRAVENOUS, SUBCUTANEOUS | 3.5 mg in 1 1 | 7/29/2023 | |
| MAIA Pharmaceuticals, Inc. | 70511-162 | INTRAVENOUS | 2.5 mg in 1 1 | 8/10/2022 | |
| Apotex Corp | 60505-6050 | INTRAVENOUS, SUBCUTANEOUS | 3.5 mg in 1 1 | 3/20/2024 | |
| Hospira, Inc. | 0409-1704 | INTRAVENOUS, SUBCUTANEOUS | 1 mg in 1 1 | 12/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/14/2019 | ||
Authorised | 7/20/2015 | ||
Authorised | 4/26/2004 | ||
Authorised | 7/22/2016 | ||
Authorised | 7/22/2016 | ||
Authorised | 7/22/2016 | ||
Authorised | 4/26/2004 | ||
Authorised | 7/22/2016 | ||
Authorised | 7/22/2016 | ||
Authorised | 11/14/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BORTEZOMIB KABI POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL | SIN16472P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.5mg/vial | 4/8/2022 | |
| BORTESUN POWDER FOR SOLUTION FOR INJECTION 3.5 MG/ VIAL | SIN15594P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.5mg/vial | 12/10/2018 | |
| VELTEZOM POWDER FOR SOLUTION FOR INJECTION 3.5MG | SIN16421P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.5 mg/ vial | 1/26/2022 | |
| BORTEZOMIB-AFT POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL | SIN16586P | INJECTION, POWDER, FOR SOLUTION | 3.5mg/vial | 9/1/2022 | |
| VELCADE 3.5mg FOR INJECTION | SIN13064P | INJECTION, POWDER, FOR SOLUTION | 3.5mg | 3/15/2005 | |
| PFIZER BORTEZOMIB POWDER FOR INJECTION 3.5MG | SIN15900P | INJECTION, POWDER, FOR SOLUTION | 3.50mg | 3/11/2020 | |
| MIBZO POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL | SIN16892P | INJECTION, POWDER, FOR SOLUTION | 3.500mg/vial | 10/25/2023 | |
| BORACTIB POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL | SIN15243P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.5 mg/vial | 5/26/2017 | |
| ZOMOD 3.5 POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL | SIN15853P | INJECTION, POWDER, FOR SOLUTION | 3.5 mg/vial | 11/14/2019 | |
| BORTEZOMIB-TEVA POWDER FOR SOLUTION FOR INJECTION 3.5MG/VIAL | SIN16732P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.5mg/vial | 3/3/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bortezomib for Injection | 国药准字H20253217 | 化学药品 | 注射剂 | 1/14/2025 | |
| Bortezomib for Injection | 国药准字H20253697 | 化学药品 | 注射剂 | 3/25/2025 | |
| Bortezomib for Injection | 国药准字H20258062 | 化学药品 | 注射剂 | 4/9/2025 | |
| Bortezomib for Injection | 国药准字H20244587 | 化学药品 | 注射剂 | 7/30/2024 | |
| Bortezomib for Injection | 国药准字H20243439 | 化学药品 | 注射剂 | 4/7/2024 | |
| Bortezomib for Injection | 国药准字H20253276 | 化学药品 | 注射剂 | 1/24/2025 | |
| Bortezomib for Injection | 国药准字H20204018 | 化学药品 | 注射剂 | 5/5/2023 | |
| Bortezomib for Injection | 国药准字H20183101 | 化学药品 | 注射剂 | 2/1/2023 | |
| Bortezomib for Injection | 国药准字H20234692 | 化学药品 | 注射剂 | 12/26/2023 | |
| Bortezomib for Injection | 国药准字H20234717 | 化学药品 | 注射剂 | 12/29/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BORTEZOMIB SANDOZ POWDER FOR SOLUTION FOR INJECTION 3.5MG | N/A | N/A | N/A | 3/24/2025 | |
| ACCORD BORTEZOMIB POWDER FOR SOLUTION FOR INJECTION 3.5MG | N/A | i & c (hong kong) limited | N/A | N/A | 3/10/2017 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DBL Bortezomib bortezomib 1.0 mg powder for injection vial | 313359 | Medicine | A | 2/10/2020 | |
| BORTEZOMIB JN bortezomib 3.5 mg powder for injection vial | 283341 | Medicine | A | 4/12/2018 | |
| BORTEZOMIB JUNO bortezomib 1mg powder for injection vial | 283340 | Medicine | A | 4/12/2018 | |
| BORTRACZO bortezomib 3.5 mg/1.4 mL solution for injection | 444812 | Medicine | A | 5/22/2025 | |
| GenRx Bortezomib bortezomib 3.5mg powder for injection vial | 215826 | Medicine | A | 7/22/2015 | |
| BORTEZOMIB ACCORD bortezomib 1 mg powder for injection vial | 315491 | Medicine | A | 2/9/2021 | |
| BORTEZOMIB GPPL bortezomib 3.5 mg powder for injection vial | 214245 | Medicine | A | 8/5/2021 | |
| BORTEZOMIB HETERO bortezomib 3.5 mg powder for injection vial | 214243 | Medicine | A | 8/5/2021 | |
| BORTEZOMIB BAXTER bortezomib 3.5 mg powder for injection vial | 379611 | Medicine | A | 8/4/2022 | |
| BORTEZOMIB JN bortezomib 2.5 mg powder for injection vial | 303982 | Medicine | A | 10/1/2019 |