Inhibikase Therapeutics, Inc. (IKT), a clinical-stage pharmaceutical company, announced that it has enrolled the first patient in its pivotal Phase 3 study, dubbed IMPROVE-PAH, evaluating its lead investigational candidate, IKT-001, for the treatment of Pulmonary Arterial Hypertension (PAH).
IKT 001 is a novel oral prodrug of imatinib mesylate designed to improve gastrointestinal tolerability compared with imatinib, which was approved in the United States in 2001 for certain cancers and blood disorders.
The global IMPROVE-PAH(IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH) trial is a two-part adaptive Phase 3 study. Part A of IMPROVE-PAH, which is a double-blind, placebo-controlled study in approximately 140 patients, with a primary endpoint of change in Pulmonary Vascular Resistance at Week 24.
Part B of IMPROVE-PAH is expected to begin after the last patient in Part A is enrolled and follows the same format as Part A, except that the primary endpoint will be change in 6-minute walk distance ("6MWD") at Week 24 in approximately 346 patients. IMPROVE-PAH is conducted at 180 sites, and the Phase 3 study protocol also permits a sample-size re-estimation for Part B based on Part A findings, if required.
Mark Iwicki, Chief Executive Officer of Inhibikase, said, "Enrollment of the first patient in our IMPROVE-PAH trial is a major milestone for Inhibikase".
PAH is a progressive, life-threatening disease characterised by pulmonary vascular remodelling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans estimates Inhibikase.
According to Grand View Research, the global pulmonary arterial hypertension market size was estimated at $8.02 billion in 2024 and is projected to reach $13.34 billion by 2033.
For the full year 2025.IKT reported incurring a net loss of $48.3 million, or $0.49 per share, compared to a net loss of $27.5 million, or $1.16 per share, in the prior year.
As of December 31, 2025, the company had cash, cash equivalents and marketable securities of $178.8 million
IKT has traded between $1.33 and $2.36 over the last year. IKT closed Tuesday's trade at $1.76, down 1.68%.
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