Dutasteride
As of the edition of 20 October 2026, Dutasteride is a small molecule: marketed, first approved in 2001 (US); acts on SRD5A1, SRD5A2 and SRD5A3; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Avodart
- First approved
- 20 November 2001 (US)
- Approvals on record
- 11 in 7 regions
- Holder of the most recent approval
- GSK; 2 holders in all
- Registered trials
- 82, 11 stopped early
- Disease areas
- Urinary and reproductive; Cancer; Mental health; Skin and connective tissue; Chemically induced; Hormones
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
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Dutasteride.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 21 | 15 | 4 | 0 |
| Phase 1 | 16 | 14 | 1 | 1 |
| Phase 2 | 22 | 12 | 2 | 6 |
| Phase 3 | 13 | 10 | 0 | 2 |
| Phase 4 | 10 | 7 | 0 | 2 |
| All trials | 82 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator and Lead sponsor of trials | 2001 to now |
| Waylis Therapeutics | Acquired holder | 2024 to now |