FDA Approves Updated Label for Tryvio (aprocitentan)

April 9, 2025 — Idorsia Ltd recently announced that the US Food & Drug Administration (FDA), after having released Tryvio from its REMS (Risk Evaluation and Mitigation Strategy) requirement (announced March 17, 2025), has now approved the updated label for Tryvio (aprocitentan).

Tryvio is Idorsia’s dual endothelin receptor antagonist (ERA) indicated for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs. The FDA determined that a REMS was no longer necessary to ensure the benefits of Tryvio outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information.

Michael Moye, president and general manager of Idorsia US, commented, “The fact that the FDA has expedited the approval of the updated Tryvio label to remove the REMS requirements is, I believe, a testament to the importance of Tryvio. As shown in the Phase 3 PRECISION study, Tryvio decreased systolic blood pressure by more than 15 mmHg from baseline in patients with confirmed resistant hypertensive despite treatment with a combination of antihypertensives. The durable efficacy was achieved with a good safety and tolerability profile. Decreasing BP to such an extent in these high cardiovascular risk patients is known to markedly decrease the risk of fatal and non-fatal cardiovascular events, such as strokes and myocardial infarctions. Idorsia will now work with a sense of urgency to make Tryvio available in retail pharmacies and simplify the administration for prescribers, distributors, and ultimately for patients."

For the updated Tryvio labeling, please see the Full Prescribing Information including BOXED Warning (PI and Medication Guide).

Tryvio is commercially available through Walgreens Specialty Pharmacy. For more information visit these websites:
US Healthcare Professionals: www.TRYVIOhcp.com
US Patients: www.TRYVIO.com

New Study Addresses Effect of Aprocitentan for Reducing Blood Pressure and Proteinuria

Idorsia Ltd also announced the publication of "Aprocitentan for Blood Pressure Reduction in Black Patients” in the April edition of Hypertension¹. The publication reports preplanned analyses of the efficacy, tolerability and safety of aprocitentan – Idorsia’s once-daily, orally active, dual endothelin receptor antagonist – in the subgroup of African American patients enrolled in the Phase 3 PRECISION study² in patients with confirmed resistant hypertension. Aprocitentan, when added to a combination of at least three antihypertensive drugs (four in more than 50% of patients), produced clinically meaningful and sustained blood pressure reductions.¹ Aprocitentan also markedly decreased proteinuria in the patients with proteinuria at baseline.¹ As reported by the authors, aprocitentan was safe and well tolerated, even in those Black patients with chronic kidney disease.¹

To learn more about the study, click here.

1. Flack JM, et al. Aprocitentan for Blood Pressure Reduction in Black Patients. Hypertension. 2025;82:601–610