At a glance
- Bortezomib is an FDA-approved drug, marketed as Velcade, Bortezomib (first approval: May 13, 2003).
- PubMed lists 12,092 publications mentioning it, including 378 randomized controlled trials and 532 animal-only studies.
- ClinicalTrials.gov lists 1,110 registered studies testing it (196 active).
- FDA's adverse event system (FAERS) holds 90,381 reports mentioning it; 76,002 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA021602 | VELCADE | Approved, marketed | May 13, 2003 | TAKEDA PHARMS USA |
| NDA205004 | BORTEZOMIB | Approved, discontinued | November 6, 2017 | FRESENIUS KABI USA |
| NDA206927 | BORTEZOMIB | Approved, discontinued | October 4, 2019 | DR REDDYS |
| ANDA205533 | BORTEZOMIB | Approved, marketed | May 2, 2022 | APOTEX |
| ANDA205857 | BORTEZOMIB | Approved, discontinued | May 2, 2022 | TEVA PHARMS USA |
| ANDA208392 | BORTEZOMIB | Approved, marketed | May 2, 2022 | PHARMASCIENCE INC |
| ANDA209659 | BORTEZOMIB | Approved, marketed | May 2, 2022 | FRESENIUS KABI USA |
| ANDA210204 | BORTEZOMIB | Approved, marketed | May 2, 2022 | ZYDUS PHARMS |
| ANDA210824 | BORTEZOMIB | Approved, marketed | May 2, 2022 | QILU PHARM HAINAN |
| ANDA212825 | BORTEZOMIB | Approved, marketed | May 2, 2022 | EUGIA PHARMA |
| ANDA213823 | BORTEZOMIB | Approved, discontinued | May 2, 2022 | BAXTER HLTHCARE CORP |
| NDA209191 | BORTEZOMIB | Approved, marketed | May 2, 2022 | HOSPIRA |
| ANDA202963 | BORTEZOMIB | Approved, marketed | July 26, 2022 | DR REDDYS |
| ANDA203654 | BORTEZOMIB | Approved, discontinued | July 26, 2022 | CAPLIN ONE LABS |
| ANDA204405 | BORTEZOMIB | Approved, discontinued | July 26, 2022 | ACCORD HLTHCARE |
| ANDA208460 | BORTEZOMIB | Approved, marketed | July 26, 2022 | HOSPIRA |
| ANDA209622 | BORTEZOMIB | Approved, marketed | July 26, 2022 | MSN |
| ANDA212958 | BORTEZOMIB | Approved, marketed | July 26, 2022 | MEITHEAL |
| ANDA215011 | BORTEZOMIB | Approved, marketed | July 26, 2022 | JIANGSU HANSOH PHARM |
| NDA215441 | BORTEZOMIB | Approved, discontinued | July 26, 2022 | ACCORD HLTHCARE |
| NDA215331 | BORTEZOMIB | Approved, discontinued | July 27, 2022 | MAIA PHARMS INC |
| ANDA211898 | BORTEZOMIB | Approved, marketed | October 11, 2022 | SOMERSET THERAPS LLC |
| ANDA205160 | BORTEZOMIB | Approved, discontinued | October 31, 2022 | PHARMOBEDIENT |
| ANDA216912 | BORTEZOMIB | Approved, discontinued | September 26, 2023 | SCINOPHARM TAIWAN |
| ANDA212204 | BORTEZOMIB | Approved, marketed | May 3, 2024 | HETERO LABS LTD VI |
| NDA212782 | BORTEZOMIB | Approved, marketed | August 26, 2024 | SHILPA |
| ANDA218688 | BORTEZOMIB | Approved, marketed | June 2, 2025 | VILIN BIO MED |
| ANDA216528 | BORTEZOMIB | Approved, marketed | December 17, 2025 | SHUANGCHENG |
| ANDA219167 | BORTEZOMIB | Approved, marketed | January 6, 2026 | GLAND |
| NDA208645 | BORTEZOMIB | Tentative approval | — | ACTAVIS LLC |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Clinical efficacy and safety of medicines procured through China's national volume-based procurement policy: a systematic review of 81 studies.
- Crystalline κ-light-chain proximal tubulopathy in Waldenström macroglobulinemia with an IgA nephropathy pattern: a case report and systematic review.
- Single-cell analysis reveals favorable responses of tumor-associated monocytes to bortezomib-based treatment in multiple myeloma.
- Daratumumab in immune-mediated thrombotic thrombocytopenic purpura: emerging evidence for plasma cell-targeted therapy.
- Crystalline versus non-crystalline light-chain proximal tubulopathy: a case series.
- Proliferating Cell Nuclear Antigen as New Therapeutic Target in Multiple Myeloma.
- ALDH2 Suppresses Ferroptosis and Promotes Bortezomib Resistance in Multiple Myeloma Through the KEAP1-NRF2 Feedback Loop.
- Contrasting molecular and pharmacodynamic signatures of response and resistance to sequential bortezomib and temozolomide in recurrent IDH-wildtype glioblastoma and grade 4 IDH-mutant astrocytoma: an exploratory interim analysis of NCT03643549 phase IB/II trial.
- Pirenzepine Reverses Chemotherapy-Induced Peripheral Neuropathy in Mice.
- Case Report: Sepsis With Multisystemic Amyloid Light-Chain Amyloidosis.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 1,110
- Active
- 196
- With posted results
- 344
Conditions studied
Show 40 more studies
All 1,110 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 90,381
- Serious
- 76,002
- With death outcome
- 14,201
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- BORTEZOMIB
- Bortezomib
- Bortezomib
- Bortezomib
- BORTEZOMIB
- Bortezomib
- VELCADE
- Bortezomib
- Bortezomib
- BORUZU
- Bortezomib
- Bortezomib
- BORTEZOMIB
- Bortezomib
- BORTEZOMIB
- Bortezomib
- Bortezomib
- Bortezomib
- Bortezomib
- BORTEZOMIB
- Bortezomib
- BORTEZOMIB
- Bortezomib
- Bortezomib
- Bortezomib
- BORTEZOMIB
- Bortezomib
- Bortezomib
- bortezomib
- Bortezomib
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.