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Aprocitentan

Generic Name
Aprocitentan
Brand Names
Jeraygo
Drug Type
Small Molecule
Chemical Formula
C16H14Br2N6O4S
CAS Number
1103522-45-7
Unique Ingredient Identifier
MZI81HV01P
Background

Aprocitentan is under investigation in clinical trial NCT03541174 (A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety).

Clinical Trials
Related News

FDA Approves First TAVR Therapy for Asymptomatic Severe Aortic Stenosis Patients

• Edwards Lifesciences' SAPIEN 3 platform has received FDA approval for treating asymptomatic patients with severe aortic stenosis, marking the first such approval for transcatheter aortic valve replacement in this patient population. • The groundbreaking EARLY TAVR trial demonstrated superior outcomes with TAVR compared to watchful waiting, with 26.8% versus 45.3% of patients experiencing death, stroke, or unplanned cardiovascular hospitalization over a median 3.8-year follow-up. • This approval challenges the current "watchful waiting" approach to asymptomatic severe aortic stenosis, potentially transforming treatment pathways as symptoms can develop suddenly and unpredictably in these patients.

Aprocitentan Shows Significant Blood Pressure and Proteinuria Reduction in Black Patients with Resistant Hypertension

• Aprocitentan, a dual endothelin receptor antagonist, demonstrated clinically meaningful and sustained blood pressure reductions in Black patients with resistant hypertension when added to existing antihypertensive regimens. • The drug significantly reduced proteinuria by approximately 65% at the 25mg dose in patients with micro- or macroalbuminuria, addressing a critical need in a population disproportionately affected by hypertension-related complications. • Published in Hypertension, the PRECISION study subgroup analysis highlights aprocitentan as the first approved treatment targeting the endothelin system, potentially preventing thousands of cardiovascular events in Black patients who often struggle to achieve blood pressure control.

FDA Removes REMS Requirement for TRYVIO, Simplifying Access to Novel Hypertension Treatment

• The US FDA has eliminated the Risk Evaluation and Mitigation Strategy (REMS) requirement for TRYVIO (aprocitentan), determining that standard labeling is sufficient to communicate safety information. • TRYVIO, a dual endothelin receptor antagonist, is the first new antihypertensive medication with a novel mechanism of action in over 40 years, capable of reducing systolic blood pressure by more than 15 mmHg. • The removal of REMS requirements simplifies prescribing for healthcare providers and improves access for patients with difficult-to-control hypertension, including those with chronic renal failure.

Mineralys Therapeutics' Lorundrostat Advances to Phase 2 for Obstructive Sleep Apnea and Hypertension

• Mineralys Therapeutics' lorundrostat receives FDA clearance for a Phase 2 trial targeting obstructive sleep apnea (OSA) in hypertensive patients. • The trial aims to assess lorundrostat's efficacy in reducing upper airway obstruction and nocturnal hypertension in moderate-to-severe OSA. • The Phase 2 study is set to commence in Q1 2025, evaluating 50mg of lorundrostat daily in approximately 40 participants. • Mineralys' Explore-CKD Phase 2 trial, evaluating lorundrostat for hypertension in CKD patients with albuminuria, has completed enrollment.

FDA Approves Tryvio (aprocitentan) for Hypertension Treatment in Combination with Other Antihypertensives

• The FDA approved aprocitentan (Tryvio) in March 2024, an endothelin receptor antagonist, for hypertension treatment when combined with other antihypertensive medications. • The approval was based on the Phase 3 PRECISION trial, demonstrating a significant reduction in sitting systolic blood pressure (SiSBP) compared to placebo. • Common adverse reactions in the PRECISION study included edema or fluid retention, with most cases being mild to moderate in severity. • Aprocitentan, available in 12.5 mg and 25 mg tablets, is the first FDA-approved treatment targeting the endothelin system for hypertension.
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