Clobetasol propionate
As of the edition of 20 October 2026, Clobetasol propionate is a small molecule: marketed, first approved in 1985 (US); acts on NR3C1; 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 2017
- Kind
- Small molecule
- Brand name
- Temovate
- First approved
- 27 December 1985 (US)
- Approvals on record
- 17 in 3 regions
- Holder of the most recent approval
- Harrow Eye; 8 holders in all
- Registered trials
- 31, 3 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Cancer; Digestive system; Eye; Inherited and neonatal
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.
Harrow Eye holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Clobetasol propionate.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| NR3C1 | Glucocorticoid receptor | P04150 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 4 | 1 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 7 | 5 | 0 | 2 |
| Phase 3 | 11 | 9 | 1 | 1 |
| Phase 4 | 5 | 5 | 0 | 0 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Earlier holder | 1985 to now |
| Galderma | Later holder | 2003 to now |
| Dow Pharmaceutical Sciences | Later holder | 2005 to now |
| Stiefel | Later holder | 2007 to now |
| Dr. Reddy's | Later holder and Lead sponsor of trials | 2014 to now |
| Maruho | Applicant | 2017 to now |
| Primus Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2017 to now |
| Viatris | Later holder | 2020 to now |
| Formosa Pharmaceuticals | Later holder | 2024 to now |
| Pharmobedient Consulting | Acquired holder | 2025 to now |
| Harrow Eye | Acquired holder | 2025 to now |
| Quagen Pharmaceuticals | Acquired holder | 2026 to now |
| Fougera Pharmaceuticals | Acquired holder | 2026 to now |