Betamethasone valerate
As of the edition of 20 October 2026, Betamethasone valerate is a small molecule: marketed, first approved in 1970 (CA); acts on NR3C1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Valisone
- First approved
- 31 December 1970 (CA)
- Approvals on record
- 23 in 2 regions
- Holder of the most recent approval
- LEO Pharma; 9 holders in all
- Registered trials
- 10, 0 stopped early
- Disease areas
- Skin and connective tissue; Immune system; Inherited and neonatal; Infections
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Betamethasone valerate.
See the 4 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 | 2 | 0 | 1 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 3 | 1 | 2 | 0 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 1970 to now |
| Teva | Later holder | 1983 to now |
| Fougera Pharmaceuticals | Later holder | 1983 to now |
| Pharmaderm | Acquired holder | 2003 to now |
| Savage | Acquired holder | 2003 to now |
| Tj Roaco | Acquired holder | 2003 to now |
| LEO Pharma | Later holder | 2018 to now |
| Cosette Pharmaceuticals Nc | Acquired holder | 2026 to now |
| Quagen Pharmaceuticals | Acquired holder | 2026 to now |
| Merck & Co. | Applicant |