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A Phase 2b randomized, double-blind, placebo-controlled clinical study of ninerafaxstat in non-obstructive hypertrophic cardiomyopathy (nHCM)

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Trial Profile

A Phase 2b randomized, double-blind, placebo-controlled clinical study of ninerafaxstat in non-obstructive hypertrophic cardiomyopathy (nHCM)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2025

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At a glance

  • Drugs Ninerafaxstat (Primary)
  • Indications Hypertrophic cardiomyopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms FORTITUDE-HCM
  • Sponsors Imbria Pharmaceuticals

Most Recent Events

  • 10 Apr 2025 The company plans to initiate this study in Q2 2025, with topline data in late 2026.
  • 14 Nov 2023 New trial record
  • 07 Nov 2023 According to an Imbria Pharmaceuticals media release, Based on the topline results from IMPROVE-HCM, company is focused on advancing ninerafaxstat into a Phase 3 clinical trial of patients with nHCM and plan to meet with regulatory agencies within the coming months to confirm trial design.

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