Paclitaxel
As of the edition of 20 October 2026, Paclitaxel is a small molecule: marketed, first approved in 1992 (US); acts on TUBB, TUBB1 and TUBB2A and 6 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Taxol
- First approved
- 29 December 1992 (US)
- Approvals on record
- 22 in 6 regions
- Holder of the most recent approval
- BIOPAS BRASIL PRODUTOS FARMACEUTICOS LTDA; 10 holders in all
- Withdrawn from market
- 9 February 2024 (in some regions)
- Registered trials
- 3,569, 507 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Hormones; Lungs and airways; Urinary and reproductive
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| TUBB4A | Tubulin beta-4A chain | P04350 |
| TUBB | Tubulin beta chain | P07437 |
| TUBB4B | Tubulin beta-4B chain | P68371 |
| TUBB3 | Tubulin beta-3 chain | Q13509 |
| TUBB2A | Tubulin beta-2A chain | Q13885 |
| TUBB8 | Tubulin beta-8 chain | Q3ZCM7 |
| TUBB6 | Tubulin beta-6 chain | Q9BUF5 |
| TUBB2B | Tubulin beta-2B chain | Q9BVA1 |
| TUBB1 | Tubulin beta-1 chain | Q9H4B7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 138 | 53 | 35 | 12 |
| Phase 1 | 637 | 371 | 103 | 108 |
| Phase 2 | 2,168 | 908 | 584 | 320 |
| Phase 3 | 591 | 250 | 178 | 66 |
| Phase 4 | 35 | 9 | 13 | 1 |
| All trials | 3,569 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator and Lead sponsor of trials | 1992 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2002 to now |
| Taiho | Applicant and Lead sponsor of trials | 2008 to now |
| Nippon Kayaku | Later holder and Lead sponsor of trials | 2012 to now |
| Hq Specialty Pharma | Acquired holder | 2013 to now |
| Teva | Later holder | 2023 to now |
| American Regent | Acquired holder | 2023 to now |
| Sawai Pharmaceutical | Later holder |