Hydroxyprogesterone caproate
As of the edition of 20 October 2026, Hydroxyprogesterone caproate is a small molecule: marketed, first approved in 1982 (US); acts on PGR; no US protection is listed.
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
- Delalutin
- First approved
- 1 January 1982 (US)
- Approvals on record
- 10 in 1 region
- Holder of the most recent approval
- COVIS PHARMA GMBH; 4 holders in all
- Withdrawn from market
- 1 January 2024 (in some regions)
- Registered trials
- 8, 3 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive
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 Hydroxyprogesterone caproate.
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 |
|---|---|---|
| PGR | Progesterone receptor | P06401 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 0 | 2 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 2 | 1 | 0 | 1 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Kv Pharmaceutical | Later holder | 2011 to now |
| AbbVie | Acquired holder | 2016 to now |
| Epic Pharma | Acquired holder | 2023 to now |
| Akorn | Later holder | |
| Bristol Myers Squibb | Applicant |