Treats hypertension. NDA 217686, held by Idorsia. Aprocitentan.
As of Nov 13, 2026, NDA 217686 (Tryvio), held by Idorsia, was first approved by FDA on Mar 19, 2024, with 4 approved supplements and 0 published complete response letters.
TRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with TRYVIO.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tryvio12.5MG · tablet;oral | Aprocitentan | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2026 | Supplement 5Labeling · Standard review | Approved | |
| Apr 2, 2025 | Supplement 4REMS | Approved | |
| Dec 9, 2024 | Supplement 3REMS | Approved | |
| Aug 7, 2024 | Supplement 2REMS | Approved | |
| Mar 19, 2024 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
