Tryvio FDA Approval History
Last updated by Judith Stewart, BPharm on April 16, 2025.
FDA Approved: Yes (First approved March 19, 2024)
Brand name: Tryvio
Generic name: aprocitentan
Dosage form: Tablets
Company: Idorsia Ltd.
Treatment for: High Blood Pressure
Tryvio (aprocitentan) is an endothelin receptor antagonist (ERA) for the combination treatment of hypertension that is not adequately controlled with other drugs.
- Tryvio is indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs.
- Hypertension is a common condition characterized by persistently high blood pressure (140/90 mmHg or higher). Lowering high blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
- Tryvio works by targeting endothelin-1 (ET-1), a potent vasoconstrictor implicated in the pathogenesis of hypertension. It works by inhibiting the binding of ET-1 to ETA and ETB receptors to mediate the harmful effects of ET-1, including vasoconstriction, fibrosis, cell proliferation, and inflammation.
- Tryvio tablets are administered once daily, with or without food.
- Tryvio comes with a Boxed Warning for embryo-fetal toxicity. Tryvio must not be taken during pregancy and acceptable contraception should be used prior to initiation of treatment, during treatment, and for one month after stopping treatment.
- Warnings and precautions associated with Tryvio include hepatotoxicity, fluid retention, reduced hemoglobin, and reduced sperm counts.
- Common adverse reactions include edema/fluid retention and anemia.
Development timeline for Tryvio
Further information
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