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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: 04 Dec 2024

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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

    • 02 Dec 2024 According to a Cytokinetics media release, company announced that the U.S. Food & Drug Administration (FDA) has accepted the company New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM), PDUFA Target Action Date Set for September 26, 2025. The results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial, which form the foundation of the NDA.
    • 16 Nov 2024 According to a Cytokinetics media release, data from the study were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL.
    • 16 Nov 2024 Results presented in the Cytokinetics Media Release.

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