Finasteride
As of the edition of 20 October 2026, Finasteride is a small molecule: marketed, first approved in 1992 (US); acts on SRD5A2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1993
- Kind
- Small molecule
- Brand name
- Proscar
- First approved
- 19 June 1992 (US)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- BLUE WATER BIOTECH INC; 5 holders in all
- Registered trials
- 48, 6 stopped early
- Disease areas
- Urinary and reproductive; Cancer; Skin and connective tissue; Nervous system; Hormones; Eye
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 Finasteride.
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 |
|---|---|---|
| SRD5A2 | 3-oxo-5-alpha-steroid 4-dehydrogenase 2 | P31213 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 2 | 0 |
| Phase 1 | 14 | 14 | 0 | 0 |
| Phase 2 | 17 | 9 | 1 | 5 |
| Phase 3 | 7 | 4 | 1 | 1 |
| Phase 4 | 5 | 1 | 3 | 0 |
| All trials | 48 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator and Lead sponsor of trials | 1992 to now |
| Organon | Applicant and Acquired holder | 1993 to now |