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An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension (PAH)

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Trial Profile

An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension (PAH)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Feb 2026

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At a glance

  • Drugs IKT 001PRO (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms IMPROVE-PAH
  • Sponsors Inhibikase Therapeutics

Most Recent Events

  • 20 Nov 2025 According to a Inhibikase Therapeutics media, given the Company was well-advanced in initiating the previous Phase 2b study design, the Company expects to initiate IMPROVE-PAH in the first quarter of 2026, with this study expected to be conducted in up to approximately 180 sites around the world.
  • 20 Nov 2025 According to a Inhibikase Therapeutics media, the Company submitted a Type C Meeting request to the U.S. Food & Drug Administration ("FDA") to, among other things, obtain feedback on an immediate transition to a pivotal Phase 3 study design.
  • 14 Nov 2025 According to a Inhibikase Therapeutics media, The Company has been actively working with potential sites expects to initiate IMPROVE-PAH in the fourth quarter of 2025.

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