FDA · United States
docetaxel — FDA regulatory status
docetaxel (DOCETAXEL ACCORD) 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
- DOCETAXEL ACCORD
- Originator
- Accord Healthcare Pty.
- Mechanism
- Tubulin inhibitor
- Target
- Tubulin
- Structured fields
- 8
Sponsor / originator context: Accord Healthcare Pty.. 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: Tubulin inhibitor. Target: Tubulin. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 120 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 |
|---|---|---|---|
| 000434 | Phase 3 | Ferring Pharmaceuticals | 2024-512177-27-01 |
| 20190009 | Phase 3 | Amgen | 2023-508214-42-00 |
| 2020HXFH037 | Phase 3 | Chinese Academy of | NCT04414566 |
| 2022-009 | Phase 3 | Ningbo Cancer Hospital | 2024-516576-15-00 |
| 20230239 | Phase 3 | Amgen | 2025-520555-89-00 |
| 213410 | Phase 3 | GSK Glaxo Smith | 2023-507475-21-00 |
| 42756493BLC3001 | Phase 3 | Janssen-Cilag International N.V | 2023-510296-56-00 |
| 5-Fu/epirubicin/CTX following Docetaxel | Phase 3 | Chinese Academy of | NCT01642771 |
| 7465-CL-0301 | Phase 3 | Astellas Pharma | 2024-517571-20-00 |
| 78278343PCR3003 | Phase 3 | Janssen-Cilag International N.V | 2025-522713-29-00 |
| BNT323-01 | Phase 3 | BioNTech SE | 2023-507525-42-00 |
| C2321014 | Phase 3 | First Biotech (Australia) | 2024-511650-50-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12258366 | Bicyclic heteroaryl compounds and uses thereof | US |
| 11987590 | Compounds that participate in cooperative binding and uses thereof | US |
| 11607407 | Dermal pharmaceutical compositions of 1-methyl-2′,6′-pipecoloxylidide and method of use | US |
| 11512128 | VEGF/DLL4 binding agents and uses thereof | US |
| 11434204 | Method for producing a polymorphic form of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide | US |
| 11234967 | Use of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-n-cyclopropyl-4-methylbenzamide in the prevention or reduction of acute exacerbations of chronic obstructive pulmonary disease | US |
| 11168102 | Bicyclic heteroaryl compounds and uses thereof | US |
| 11059830 | Compounds that participate in cooperative binding and uses thereof | US |
| 10995071 | Method for producing a polymorphic form of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide | US |
| 10948495 | Methods and reagents for analyzing protein-protein interfaces | US |
| 10934260 | Method for producing a polymorphic form of 3-[5-amino-4-(3- cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide | US |
| 10624887 | Compositions of (-)-17-(cyclobutylmethyl)morphinan-3,14,-diol | US |
Related hubs
FAQ
What is the FDA approval status of docetaxel?
docetaxel 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 docetaxel 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 docetaxel?
This spoke lists 120 published programs associated with docetaxel in our pipeline index.