Tazarotene
As of the edition of 20 October 2026, Tazarotene is a small molecule: marketed, first approved in 1997 (US); acts on RARA, RARB and RARG; no US protection is listed.
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
- Tazorac
- First approved
- 13 June 1997 (US)
- Approvals on record
- 10 in 2 regions
- Holder of the most recent approval
- Bausch Health; 3 holders in all
- Registered trials
- 45, 3 stopped early
- Disease areas
- Skin and connective tissue; Cancer; Bones, joints and muscles; Inherited and neonatal; Mouth and teeth; Blood and lymph
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.
Companies that need a new molecule because of this drug
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Tazarotene.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 5 | 0 | 0 |
| Phase 1 | 8 | 8 | 0 | 0 |
| Phase 2 | 12 | 8 | 0 | 2 |
| Phase 3 | 11 | 10 | 0 | 1 |
| Phase 4 | 8 | 5 | 1 | 0 |
| All trials | 45 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Originator and Lead sponsor of trials | 1997 to now |
| Stiefel | Later holder | 2012 to now |
| Almirall | Acquired holder and Lead sponsor of trials | 2014 to now |
| Bausch Health | Later holder and Lead sponsor of trials | 2015 to now |
| Pfizer | Acquired holder | 2017 to now |