Tretinoin
As of the edition of 20 October 2026, Tretinoin is a small molecule: marketed, first approved in 1975 (CH); acts on RARA, RARB and RARG.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Retin-A
- First approved
- 7 April 1975 (CH)
- Approvals on record
- 41 in 6 regions
- Holder of the most recent approval
- BIOPAS BRASIL PRODUTOS FARMACEUTICOS LTDA; 15 holders in all
- Registered trials
- 160, 22 stopped early
- Disease areas
- Cancer; Blood and lymph; Skin and connective tissue; Immune system; Lungs and airways; Heart and blood vessels
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.
Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Tretinoin.
See the 3 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 | 10 | 4 | 2 | 1 |
| Phase 1 | 27 | 18 | 1 | 5 |
| Phase 2 | 73 | 34 | 16 | 13 |
| Phase 3 | 33 | 16 | 7 | 2 |
| Phase 4 | 17 | 12 | 1 | 1 |
| All trials | 160 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder, Later holder and Lead sponsor of trials | 1978 to now |
| Roche | Later holder | 1995 to now |
| Johnson & Johnson | Applicant and Later holder | 2002 to now |
| Viatris | Acquired holder | 2012 to now |
| Dow Pharmaceutical Sciences | Acquired holder | 2013 to now |
| Cheplapharm Arzneimittel | Acquired holder | 2017 to now |
| Rising Pharma | Acquired holder | 2025 to now |