FDA · United States
paclitaxel — FDA regulatory status
paclitaxel (PACLITAXEL 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
- PACLITAXEL 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: 230 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 |
|---|---|---|---|
| 1407-GUCG | Phase 3 | Ningbo Cancer Hospital | 2024-513509-30-00 |
| 2022-009 | Phase 3 | Ningbo Cancer Hospital | 2024-516576-15-00 |
| 7465-CL-0301 | Phase 3 | Astellas Pharma | 2024-517571-20-00 |
| ALKS 4230-007 | Phase 3 | Createrna Science and | 2024-513230-38-00 |
| AT148006 | Phase 3 | Createrna Science and | 2023-509406-30-00 |
| Abraxane /ml powder for dispersion for infusion. for metastatic NSCLC patients | Phase 3 | Telethon Foundation | 2025-522084-15-00 |
| B013+Nab-Paclitaxel | Phase 3 | BRIGHT MINDS BIOSCIENCES | NCT05555706 |
| BNT323-01 | Phase 3 | BioNTech SE | 2023-507525-42-00 |
| BNT327-05 | Phase 3 | BioNTech SE | 2025-521884-12-00 |
| BNT327-06 | Phase 3 | BioNTech SE | 2024-515764-31-00 |
| BO40729 | Phase 3 | HOFFMANN-LA ROCHE | 2023-506184-34-00 |
| BOOG 2010-02 Stop&Go study | Phase 3 | Teva Pharma | NCT01935492 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 11944617 | Concomitant administration of glucocorticoid receptor modulator relacorilant and paclitaxel, a dual substrate of CYP2C8 and CYP3A4 | US |
| 11439709 | Phospholipid ether analogs as cancer-targeting drug vehicles | US |
| 11285145 | Concomitant administration of glucocorticoid receptor modulator relacorilant and paclitaxel, a dual substrate of CYP2C8 and CYP3A4 | US |
| 9925269 | Phospholipid ether analogs as cancer-targeting drug vehicles | US |
| 9616140 | Fluorescent phospholipid ether compounds, compositions, and methods of use | US |
| 9579406 | Phospholipid ether analogs as agents for detecting and locating cancer, and methods thereof | US |
| 9550002 | Phospholipid analogs as diapeutic agents and methods thereof | US |
| 9480754 | Phospholipid ether analogs as cancer-targeting drug vehicles | US |
| 9345718 | Phospholipid ether analogs as cancer-targeting drug vehicles | US |
| 8426385 | Pharmaceutical composition comprising cyclodextrin paclitaxel inclusion and preparation method thereof | US |
| 7179588 | Assay for the detection of paclitaxel resistant cells in human tumors | US |
| 6569459 | Method of administration of paclitaxel-plasma protein formulation | US |
Related hubs
FAQ
What is the FDA approval status of paclitaxel?
paclitaxel 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 paclitaxel 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 paclitaxel?
This spoke lists 230 published programs associated with paclitaxel in our pipeline index.