Inhibikase Therapeutics Announces FDA Orphan Drug Designation Granted to IKT-001 for the Treatment of PAH

WILMINGTON, Del., July 23, 2026 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension (“PAH”), today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to its lead product candidate IKT-001, a prodrug of imatinib mesylate, for the treatment of PAH.

"The grant of Orphan Drug Designation for IKT-001 by FDA is another important milestone for Inhibikase and reflects the high unmet medical need among the approximately 50,000 people suffering from PAH in the United States,” said Mark Iwicki, Chief Executive Officer of Inhibikase. “PAH is a progressive and life-threatening disease with substantially diminished quality of life which is caused by the abnormal proliferation of vascular cells in the lung. Recently, presentations of IKT-001 pre-clinical data at the American Thoracic Society International Conference in Orlando demonstrated improvements in pulmonary vascular and hemodynamic markers of PAH, together with a lower potential for GI toxicity compared to imatinib mesylate, and we believe that IKT-001’s potential to be the first once-daily oral proliferative may offer significant potential benefits to the PAH patient population.”