Ambrisentan
As of the edition of 20 October 2026, Ambrisentan is a small molecule: marketed, first approved in 2007 (US); acts on EDNRA and EDNRB; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Letairis
- First approved
- 15 June 2007 (US)
- Approvals on record
- 10 in 6 regions
- Holder of the most recent approval
- GSK; 3 holders in all
- Registered trials
- 53, 11 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Digestive system; Skin and connective tissue; Infections; Blood and lymph
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
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Ambrisentan.
See the 2 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 | 9 | 5 | 2 | 1 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 12 | 5 | 1 | 4 |
| Phase 3 | 19 | 14 | 1 | 4 |
| Phase 4 | 7 | 5 | 0 | 2 |
| All trials | 53 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Applicant and Lead sponsor of trials | 2003 to now |
| GSK | Applicant and Lead sponsor of trials | 2007 to now |