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FDA Medication Tracker

← All approvals · Heart & blood · 2024

Tryvio (aprocitentan)

The FDA approved Tryvio (aprocitentan) on March 19, 2024 to treat hypertension.
Brand name
Tryvio
Generic name
aprocitentan
FDA approval date
March 19, 2024
Approved use (FDA wording)
To treat hypertension
Company
Idorsia
Application
NDA217686
Dosage form / route
TABLET · ORAL
Drug class (EPC)
Endothelin Receptor Antagonist [EPC]
Boxed warning on label
Yes (see the FDA label)
Category on this site
Heart & blood

Indications and usage, from the FDA 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. 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. Control of high BP should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic …

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.