Alitretinoin
As of the edition of 20 October 2026, Alitretinoin is a small molecule: marketed, first approved in 1999 (US); acts on RARA, RARB and RARG and 3 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 2009
- Kind
- Small molecule
- Brand name
- Panretin
- First approved
- 2 February 1999 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- GSK; 3 holders in all
- Registered trials
- 13, 1 stopped early
- Disease areas
- Skin and connective tissue; Cancer; Digestive system; Immune system; Infections; 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
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 1 |
| Phase 3 | 6 | 5 | 0 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ligand Pharmaceuticals | Earlier holder | 1999 to now |
| GSK | Applicant and Lead sponsor of trials | 2009 to now |
| Advanz Pharma | Acquired holder | 2025 to now |