Aprocitentan
As of the edition of 20 October 2026, Aprocitentan is a small molecule: marketed, first approved in 2024 (US); acts on EDNRA and EDNRB; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Tryvio
- First approved
- 19 March 2024 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Idorsia Pharmaceuticals Deutschland; 2 holders in all
- Registered trials
- 14, 1 stopped early
- Disease areas
- Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive; Digestive system
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Idorsia Pharmaceuticals.
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 product3 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Aprocitentan.
See the 3 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 1 | 10 | 10 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 3 | 1 | 1 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Idorsia Pharmaceuticals | Originator and Lead sponsor of trials | 2015 to now |
| Idorsia Pharmaceuticals Deutschland | Applicant | 2026 to now |