Docetaxel anhydrous
As of the edition of 20 October 2026, Docetaxel anhydrous is a small molecule: marketed, first approved in 1995 (EU); acts on TUBB, TUBB1 and TUBB2A and 6 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Taxotere
- First approved
- 27 November 1995 (EU)
- Approvals on record
- 49 in 7 regions
- Holder of the most recent approval
- Zhuhai Beihai Biotech; 13 holders in all
- Withdrawn from market
- 30 October 2018 (in some regions)
- Registered trials
- 1,883, 311 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Lungs and airways; Urinary and reproductive; Digestive system; Pregnancy and women's health
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
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 | 76 | 36 | 17 | 5 |
| Phase 1 | 288 | 178 | 34 | 61 |
| Phase 2 | 1,140 | 593 | 157 | 207 |
| Phase 3 | 357 | 179 | 72 | 37 |
| Phase 4 | 22 | 12 | 1 | 1 |
| All trials | 1,883 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant, Later holder and Lead sponsor of trials | 1994 to now |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 2003 to now |
| Accord Healthcare | Later holder | 2011 to now |
| Sandoz | Later holder | 2011 to now |
| Apotex | Later holder | 2012 to now |
| Actavis | Later holder | 2013 to now |
| Eagle Pharmaceuticals | Later holder | 2015 to now |
| Actavis Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals | Acquired holder | 2017 to now |
| Shilpa Medicare | Acquired holder | 2021 to now |
| Zhuhai Beihai Biotech | Later holder and Lead sponsor of trials | 2021 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2022 to now |
| Avyxa | Acquired holder | 2024 to now |