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A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

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Trial Profile

A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Sep 2025

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At a glance

  • Drugs Aficamten (Primary)
  • Indications Hypertrophic cardiomyopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms SEQUOIA-HCM
  • Sponsors Cytokinetics

Most Recent Events

  • 30 Aug 2025 According to a Cytokinetics media release, Aficamten is under regulatory review in the U.S; the Food and Drug Administration (FDA) is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025.
  • 07 Aug 2025 According to a Cytokinetics media release, a Plain Language Summary of the SEQUOIA-HCM Study was published in Future Cardiology
  • 07 Aug 2025 According to a Cytokinetics media release, regulatory Reviews of Aficamten for Obstructive HCM Progressing in U.S., E.U. and China; Late-Cycle Meeting with U.S. FDA Scheduled for September.

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