Quarterly report [Sections 13 or 15(d)]

Nature of Business

v3.25.2
Nature of Business
6 Months Ended
Jun. 30, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of Business
1.
Nature of Business

Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company developing a protein kinase inhibitor therapeutic to modify the course of cardiopulmonary disease that arises from aberrant signaling through the Abelson Tyrosine Kinases and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. The Company’s lead product candidate is IKT-001, a novel oral prodrug of the anticancer agent imatinib, an FDA approved drug for certain blood and stomach cancers. The Company plans to seek approval from the FDA for IKT-001 for the treatment of Pulmonary Arterial Hypertension (“PAH”) as an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that impacts approximately 50,000 Americans. IKT-001 is designed to improve tolerance to imatinib's active ingredient which may allow for improved safety and efficacy. The Company previously completed non-human primate safety studies and a bioequivalence clinical trial in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib mesylate and the results have been utilized to set the doses for the Company's forthcoming Phase 2b clinical study. The Phase 2b study, known as IMPROVE-PAH, is expected to be initiated in the second half of 2025 and will be a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH patients.