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Edgewise begins phase 2 EDG-15400 trial for heart failure with preserved ejection fraction

Published in Drugs development & discovery.

October 8, 2026 — Edgewise Therapeutics announced that the first patient has been dosed in EQUINOX-HFpEF, a phase 2 study of EDG-15400 for symptomatic heart failure with preserved ejection fraction.

The investigational oral drug modulates the cardiac sarcomere and is intended to address impaired heart relaxation. Improvements observed in preclinical models remain a rationale for testing, not proof of clinical benefit.

The multicenter, randomized, double-blind trial is expected to enroll approximately 90 adults aged 30–84. Participants receive 25 mg or 50 mg once daily, or placebo, for up to 12 weeks. Eligibility includes a left ventricular ejection fraction of at least 50% and New York Heart Association class II or III symptoms.

The study assesses safety, tolerability, pharmacokinetics and pharmacodynamics. The company plans to present its design on October 10 and phase 1 healthy-volunteer data on October 12 at HFSA 2026. Those presentations should not be confused with phase 2 efficacy results, which this announcement does not report.

Source: Edgewise company announcement distributed by PR Newswire, October 8, 2026.