Betamethasone
As of the edition of 20 October 2026, Betamethasone is a small molecule: marketed, first approved in 1963 (CH); 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
- Celestone
- First approved
- 24 September 1963 (CH)
- Approvals on record
- 53 in 6 regions
- Holder of the most recent approval
- Almirall; 20 holders in all
- Registered trials
- 57, 10 stopped early
- Disease areas
- Lungs and airways; Bones, joints and muscles; Inherited and neonatal; Skin and connective tissue; Infections; Nervous system
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
6 companies on route B because of this drug.
Companies on route B for this drug
In the product6 companies are on route B because of Betamethasone.
See the 6 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 | 13 | 10 | 0 | 0 |
| Phase 1 | 4 | 3 | 1 | 0 |
| Phase 2 | 7 | 2 | 1 | 0 |
| Phase 3 | 18 | 9 | 1 | 6 |
| Phase 4 | 15 | 7 | 0 | 4 |
| All trials | 57 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant | 1964 to now |
| Bausch Health | Acquired holder | 1970 to now |
| Organon | Later holder and Lead sponsor of trials | 1972 to now |
| Teva | Later holder | 1983 to now |
| Fougera Pharmaceuticals | Later holder | 1983 to now |
| LEO Pharma | Later holder and Lead sponsor of trials | 2001 to now |
| Pharmaderm | Acquired holder | 2003 to now |
| Savage | Acquired holder | 2003 to now |
| Tj Roaco | Acquired holder | 2003 to now |
| Merck & Co. | Later holder and Lead sponsor of trials | 2003 to now |
| IBSA Institut Biochimique | Later holder | 2013 to now |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 2018 to now |
| Almirall | Later holder | 2023 to now |
| Cosette Pharmaceuticals Nc | Acquired holder | 2026 to now |
| Quagen Pharmaceuticals | Acquired holder | 2026 to now |
| Shionogi | Applicant |