Halobetasol propionate
As of the edition of 20 October 2026, Halobetasol propionate is a small molecule: marketed, first approved in 1990 (US); acts on NR3C1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1993
- Kind
- Small molecule
- Brand name
- Ultravate
- First approved
- 17 December 1990 (US)
- Approvals on record
- 10 in 2 regions
- Holder of the most recent approval
- Bausch Health; 4 holders in all
- Registered trials
- 14, 3 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Inherited and neonatal
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Halobetasol propionate.
See the 1 company 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 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 4 | 2 | 0 | 2 |
| Phase 3 | 4 | 3 | 0 | 1 |
| Phase 4 | 3 | 1 | 2 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder and Lead sponsor of trials | 1993 to now |
| Therapeutics | Later holder and Lead sponsor of trials | 2011 to now |
| Ferndale | Later holder | 2015 to now |
| SUN Pharmaceutical Industries | Acquired holder and Lead sponsor of trials | 2017 to now |
| Dow Pharmaceutical Sciences | Later holder | 2018 to now |
| Pfizer | Acquired holder | 2019 to now |
| Lacer Pharma | Acquired holder | 2025 to now |
| Bristol Myers Squibb | Originator | 1990 to 2018 |