Macitentan
As of the edition of 20 October 2026, Macitentan is a small molecule: marketed, first approved in 2013 (US); acts on EDNRA and EDNRB; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Opsumit
- First approved
- 18 October 2013 (US)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 6 holders in all
- Registered trials
- 56, 15 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Inherited and neonatal; Cancer; Blood and lymph; Skin and connective tissue
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by Johnson & Johnson.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product13 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 13 listings behind itRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 20 | 15 | 2 | 3 |
| Phase 2 | 9 | 6 | 0 | 3 |
| Phase 3 | 22 | 12 | 2 | 8 |
| Phase 4 | 4 | 3 | 0 | 1 |
| All trials | 56 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2008 to now |