Core Insights - Inhibikase Therapeutics is advancing its investigational drug IKT-001 into a pivotal Phase 3 clinical study for Pulmonary Arterial Hypertension (PAH), expected to start in Q1 2026, which could accelerate the FDA approval timeline by approximately three years [2][6]. Company Overview - Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing therapeutics for cardiopulmonary diseases, particularly PAH, which affects around 50,000 Americans [7]. Drug Development Details - IKT-001 is a novel pro-drug of imatinib mesylate, designed to improve pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD) by 45 meters based on previous studies [3][11]. - The company has shifted from a planned Phase 2b study to a two-part adaptive Phase 3 study, with Part A focusing on PVR and Part B on 6MWD, involving a total of approximately 486 patients [5][6]. Study Design and Expectations - The adaptive Phase 3 study design includes a 12-week dose-titration phase to optimize dosing, uninterrupted enrollment between study parts, and potential sample size adjustments based on initial findings [5][6]. - The company anticipates that the new study plan will enhance the probability of success due to improved gastrointestinal tolerability and extensive clinical experience with imatinib [6].