Bortezomib
As of the edition of 20 October 2026, Bortezomib is a small molecule: marketed, first approved in 2003 (US); acts on PSMB5; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Velcade
- First approved
- 13 May 2003 (US)
- Approvals on record
- 26 in 7 regions
- Holder of the most recent approval
- Shilpa Medicare; 14 holders in all
- Withdrawn from market
- 7 August 2025 (in some regions)
- Registered trials
- 876, 172 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Urinary and reproductive; Lungs and airways
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Bortezomib.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PSMB5 | Proteasome subunit beta type-5 | P28074 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 43 | 21 | 6 | 2 |
| Phase 1 | 181 | 127 | 12 | 37 |
| Phase 2 | 527 | 286 | 75 | 118 |
| Phase 3 | 101 | 46 | 36 | 11 |
| Phase 4 | 24 | 8 | 5 | 4 |
| All trials | 876 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Originator, Applicant and Lead sponsor of trials | 2003 to now |
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2004 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2008 to now |
| Fresenius Kabi | Later holder | 2017 to now |
| Dr. Reddy's | Later holder | 2019 to now |
| Accord Healthcare | Later holder | 2022 to now |
| Maia Pharmaceuticals | Later holder | 2022 to now |
| Shilpa Medicare | Later holder | 2024 to now |