Captopril
As of the edition of 20 October 2026, Captopril is a small molecule: marketed, first approved in 1982 (US); acts on ACE; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Capoten
- First approved
- 1 January 1982 (US)
- Approvals on record
- 12 in 2 regions
- Holder of the most recent approval
- Ethypharm; 3 holders in all
- Registered trials
- 36, 5 stopped early
- Disease areas
- Heart and blood vessels; Hormones; Urinary and reproductive; Cancer; Pregnancy and women's health; 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
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 Captopril.
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 |
|---|---|---|
| ACE | Angiotensin-converting enzyme | P12821 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 3 | 1 | 0 |
| Phase 1 | 7 | 3 | 0 | 2 |
| Phase 2 | 8 | 2 | 0 | 3 |
| Phase 3 | 5 | 3 | 2 | 0 |
| Phase 4 | 7 | 5 | 0 | 0 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Aarxion Anda | Acquired holder | 2025 to now |
| Bristol Myers Squibb | Earlier holder |