Adapalene
As of the edition of 20 October 2026, Adapalene is a small molecule: marketed, first approved in 1994 (FR); acts on RARA, RARB and RARG; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Differin
- First approved
- 26 September 1994 (FR)
- Approvals on record
- 17 in 6 regions
- Holder of the most recent approval
- COSMED INDUSTRIA DE COSMETICOS E MEDICAMENTOS S.A.; 8 holders in all
- Registered trials
- 56, 3 stopped early
- Disease areas
- Skin and connective tissue; Infections
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Bausch Health holds a later exclusivity on its own new formulation or combination product, ending 2026; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
9 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product9 company-target rows are on route B because of Adapalene.
See the 9 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 | 13 | 12 | 0 | 0 |
| Phase 1 | 9 | 6 | 1 | 1 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 12 | 11 | 0 | 1 |
| Phase 4 | 19 | 17 | 1 | 1 |
| All trials | 56 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Galderma | Applicant | 1996 to now |
| Galderma Brasil Ltda | Applicant | 1999 to now |
| Bausch Health | Acquired holder and Lead sponsor of trials | 2008 to now |
| Galderma | Applicant | 2008 to now |