FDA · United States
bortezomib — FDA regulatory status
bortezomib (BORTEZOM) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- BORTEZOM
- Originator
- Pfizer Australia Pty Ltd
- Mechanism
- 26S proteosome inhibitor
- Target
- 26S proteasome
- Structured fields
- 8
Sponsor / originator context: Pfizer Australia Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: 26S proteosome inhibitor. Target: 26S proteasome. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 49 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 207499 | Phase 3 | GSK Glaxo Smith | 2023-506877-37-00 |
| 207503 | Phase 3 | GSK Glaxo Smith | 2023-510537-28-00 |
| 54767414AMY3001 | Phase 3 | Janssen-Cilag International N.V | 2024-511967-26-00 |
| 54767414MMY3019 | Phase 3 | Janssen-Cilag International N.V | 2023-507312-13-00 |
| 64007957MMY3006 | Phase 3 | Janssen-Cilag International N.V | 2023-503444-13-00 |
| 64407564MMY3009 | Phase 3 | Janssen-Cilag International N.V | 2022-502446-27-00 |
| 68284528MMY3002 | Phase 3 | Janssen-Cilag International N.V | 2023-506588-32-00 |
| 68284528MMY3004 | Phase 3 | Janssen-Cilag International N.V | 2023-505850-16-00 |
| BB2121-MM-003 | Phase 3 | Celgene | 2023-509848-10-00 |
| Bortezomib | Phase 3 | Hospital Authority | NCT03759093 |
| C1071006 | Phase 3 | First Biotech (Australia) | 2024-514139-50-00 |
| C1071032 | Phase 3 | First Biotech (Australia) | 2023-507871-23-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12331040 | Substituted benzofuranyl and benzoxazolyl compounds and uses thereof | US |
| 12005069 | Bortezomib compositions | US |
| 11752164 | Bortezomib compositions | US |
| 11679119 | Bortezomib compositions | US |
| 11672813 | Bortezomib compositions | US |
| 11542526 | Oncolytic adenoviral vector and methods of use | US |
| 11008309 | Substituted benzofuranyl and benzoxazolyl compounds and uses thereof | US |
| 10858347 | Multicyclic compounds and uses thereof | US |
| 10399963 | Substituted benzofuranyl and benzoxazolyl compounds and uses thereof | US |
| 10167452 | Viral purification methods | US |
| 9994558 | Multicyclic compounds and methods of using same | US |
| 9938258 | Substituted 2,3-dihydrobenzofuranyl compounds and uses thereof | US |
Related hubs
FAQ
What is the FDA approval status of bortezomib?
bortezomib currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get bortezomib regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to bortezomib?
This spoke lists 49 published programs associated with bortezomib in our pipeline index.