Isotretinoin
As of the edition of 20 October 2026, Isotretinoin is a small molecule: marketed, first approved in 1982 (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 2024
- Kind
- Small molecule
- Brand name
- Accutane
- First approved
- 7 May 1982 (US)
- Approvals on record
- 22 in 5 regions
- Holder of the most recent approval
- FARMOQUĂMICA S/A; 6 holders in all
- Registered trials
- 126, 15 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Urinary and reproductive; Blood and lymph; Infections; Nervous system
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
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 Isotretinoin.
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 | 19 | 12 | 2 | 1 |
| Phase 1 | 29 | 22 | 4 | 2 |
| Phase 2 | 46 | 30 | 3 | 10 |
| Phase 3 | 20 | 12 | 3 | 2 |
| Phase 4 | 12 | 8 | 3 | 0 |
| All trials | 126 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant | 1982 to now |
| Cipher Pharmaceuticals | Later holder | 2012 to now |
| SUN Pharmaceutical Industries | Acquired holder and Lead sponsor of trials | 2015 to now |