Inhibikase Therapeutics Enrolls First Patient in Global Phase 3 IMPROVE-PAH Trial of IKT-001

On April 7, 2026, Inhibikase Therapeutics announced the enrollment of the first patient in its pivotal Phase 3 IMPROVE-PAH global study evaluating IKT-001 for the treatment of Pulmonary Arterial Hypertension (PAH). IKT-001 is a novel oral prodrug of imatinib mesylate designed to minimize gastrointestinal side effects. The IMPROVE-PAH trial is a two-part adaptive study expected to involve approximately 180 sites worldwide. Part A will enroll approximately 140 patients with a primary endpoint of change in Pulmonary Vascular Resistance (PVR) at Week 24. Part B will seamlessly follow, enrolling approximately 346 patients to evaluate the change in 6-minute walk distance (6MWD) at Week 24. The study design includes a 12-week dose-titration phase to optimize dosing and allows for sample size re-estimation for Part B based on Part A results. This single pivotal study is intended to support a future New Drug Application (NDA) filing for IKT-001 in PAH.