Tryvio FDA Approval History
Last updated by Judith Stewart, BPharm on March 19, 2024.
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. Tryvio is only available through a restricted distribution program called the Tryvio REMS.
- 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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