Quick answers
- What is Aprocitentan used for?
- The FDA-approved label (Tryvio, Idorsia Pharmaceuticals Ltd, August 14, 2026) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Aprocitentan have a boxed warning?
- Yes. The FDA label for Tryvio has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Aprocitentan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Aprocitentan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Aprocitentan?
- 1 company lists prescription products of Aprocitentan in the FDA NDC Directory, including Idorsia Pharmaceuticals Ltd.
What Aprocitentan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Tryvio, Idorsia Pharmaceuticals Ltd, effective August 14, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tryvio |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Idorsia Pharmaceuticals Ltd1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA217686 TRYVIO | Idorsia | March 19, 2024 | 4, latest August 6, 2026 2026: Labeling · 2025: REMS · 2024: REMS |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2679064, 2679070 |
|---|---|
| SPL set ID of the quoted label | dfe7a2ee-612c-4aba-834a-d68e6b59a0a6 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA217686 |
| Active ingredients (FDA) | APROCITENTAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tryvio, Idorsia Pharmaceuticals Ltd, effective August 14, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →