FDA · United States
fluorouracil — FDA regulatory status
fluorouracil (APOC-5FU) 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
- APOC-5FU
- 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: 121 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 |
|---|---|---|---|
| 2020HXFH037 | Phase 3 | Chinese Academy of | NCT04414566 |
| 20210081 | Phase 3 | Amgen | 2022-502352-31-00 |
| 20210096 | Phase 3 | Amgen | 2023-505457-40-00 |
| 20210098 | Phase 3 | Amgen | 2023-505458-16-00 |
| 5-Fluorouracil | Phase 3 | HOFFMANN-LA ROCHE | NCT01358877 |
| 5-Fluoruracil | Phase 3 | HOFFMANN-LA ROCHE | NCT01662869 |
| 61186372HNC3001 | Phase 3 | Janssen-Cilag International N.V | 2025-521917-24-00 |
| 8951-CL-0305 | Phase 3 | Astellas Pharma | 2024-519773-19-00 |
| A021502 | Phase 3 | George Institute for | 2024-517269-18-00 |
| APHP220917 | Phase 3 | PARItec | 2023-504831-42-00 |
| C4221015 | Phase 3 | First Biotech (Australia) | 2023-509405-77-00 |
| C6461003 | Phase 3 | First Biotech (Australia) | 2025-523521-18-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2025090858 | PROCÉDÉS D'IDENTIFICATION DE VARIANTS DE CAPSIDE DE VAA AYANT DES CARACTÉRISTIQUES SOUHAITÉES | WO |
| 9463193 | Individual 5-fluorouracile dose optimization in folfiri treatment | US |
Related hubs
FAQ
What is the FDA approval status of fluorouracil?
fluorouracil 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 fluorouracil 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 fluorouracil?
This spoke lists 121 published programs associated with fluorouracil in our pipeline index.