FDA · United States
capecitabine — FDA regulatory status
capecitabine (CAPECITABINE SANDOZ) 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
- CAPECITABINE SANDOZ
- Originator
- Alphapharm Pty Ltd
- Mechanism
- Thymidylate synthase inhibitor
- Target
- DNA
- Structured fields
- 8
Sponsor / originator context: Alphapharm 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: Thymidylate synthase inhibitor. Target: DNA. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 105 published clinical programs and 2 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 |
|---|---|---|---|
| 20210098 | Phase 3 | Amgen | 2023-505458-16-00 |
| 8951-CL-0305 | Phase 3 | Astellas Pharma | 2024-519773-19-00 |
| BOOG 2010-02 Stop&Go study | Phase 3 | Teva Pharma | NCT01935492 |
| C4221015 | Phase 3 | First Biotech (Australia) | 2023-509405-77-00 |
| CA244-0008 | Phase 3 | Bristol-Myers Squibb Australia | 2024-519871-24-00 |
| CA2660003 | Phase 3 | Bristol-Myers Squibb Australia | 2025-523224-45-00 |
| CA2660004 | Phase 3 | Bristol-Myers Squibb Australia | 2025-523263-37-00 |
| CAPECITABINE | Phase 3 | Disc Medicine | 2024-516956-16-01 |
| CAPECITABINE for Locally advanced stage II/III rectal cancer | Phase 3 | Telethon Foundation | 2024-519007-10-00 |
| CL3-95005-006 | Phase 3 | George Institute for | 2024-516180-85-00 |
| Capecitabine | Phase 3 | HOFFMANN-LA ROCHE | NCT01450696 |
| Capecitabine | Phase 3 | Pfizer | NCT00373113 |
Related patents
Related hubs
FAQ
What is the FDA approval status of capecitabine?
capecitabine 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 capecitabine 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 capecitabine?
This spoke lists 105 published programs associated with capecitabine in our pipeline index.