Betamethasone dipropionate
As of the edition of 20 October 2026, Betamethasone dipropionate is a small molecule: marketed, first approved in 1982 (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 2014
- Kind
- Small molecule
- Brand name
- Diprosone
- First approved
- 1 January 1982 (US)
- Approvals on record
- 26 in 3 regions
- Holder of the most recent approval
- MC2 Therapeutics; 10 holders in all
- Registered trials
- 35, 1 stopped early
- Disease areas
- Skin and connective tissue; Bones, joints and muscles; Cancer; Digestive system; Immune system; Infections
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Betamethasone dipropionate.
See the 3 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 | 7 | 6 | 1 | 0 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 7 | 4 | 1 | 1 |
| Phase 3 | 7 | 7 | 0 | 0 |
| Phase 4 | 9 | 5 | 1 | 0 |
| All trials | 35 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Fougera Pharmaceuticals | Later holder | 1984 to now |
| LEO Pharma | Applicant and Lead sponsor of trials | 2001 to now |
| Pharmaderm | Acquired holder | 2003 to now |
| Savage | Acquired holder | 2003 to now |
| Dr. Reddy's | Later holder | 2016 to now |
| Primus Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2016 to now |
| Organon | Acquired holder | 2022 to now |
| Merck & Co. | Applicant |