EMA · European Union
docetaxel — EMA regulatory status
docetaxel (DOCETAXEL ACCORD) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA 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 — EMA: 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 |
|---|---|---|---|---|
| EMA | European Union | 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 EMA approval status of docetaxel?
docetaxel currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA 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.