Bosentan
As of the edition of 20 October 2026, Bosentan is a small molecule: marketed, first approved in 2001 (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 2015
- Kind
- Small molecule
- Brand name
- Tracleer
- First approved
- 20 November 2001 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 5 holders in all
- Registered trials
- 89, 13 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Skin and connective tissue; Inherited and neonatal; Hormones; Nervous system
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 7 | 1 | 1 |
| Phase 1 | 19 | 17 | 0 | 0 |
| Phase 2 | 17 | 7 | 3 | 4 |
| Phase 3 | 27 | 17 | 1 | 6 |
| Phase 4 | 15 | 12 | 0 | 2 |
| All trials | 89 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2001 to now |