Inhibikase Therapeutics, Inc.
For the period ended May 12, 2026. Filed May 12, 2026.
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A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
May 12, 2026 · Filed May 12, 2026
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IKT$1.50+4.2%Stored close · as of Nov 6, 2026
Contents
EX-99.1 · Recent Developments
Recent Developments
| • | In late April 2026, Inhibikase received confirmation from the European Medicines Agency that the Company is permitted to initiate our Phase 3 study in PAH, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), in 12 countries in the European Union. This approval brings the total country approvals for IMPROVE-PAH to 16, including the United States, Canada, New Zealand and Argentina, and further enables the Company to leverage this approval to seek the approval of an additional 3 countries in the European Union over the coming months to supplement our ongoing broader global country regulatory approval efforts. |
| • | The global IMPROVE-PAH study is a two-part adaptive Phase 3 study incorporating an initial 12-week dose titration phase designed to enable patients to get to the highest tolerable dose of IKT-001. |
| • | Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of change in Pulmonary Vascular Resistance (“PVR”) at Week 24. |
| • | Part B of IMPROVE-PAH seamlessly begins following the last patient in Part A being enrolled and adopts an identical format to Part A, except the primary endpoint will be change in 6-minute walk distance (“6MWD”) at Week 24 in approximately 346 patients. |
| • | In addition to the titration benefits mentioned above, IMPROVE-PAH has the advantage of uninterrupted enrollment between Part A and Part B, together with the opportunity to undertake a sample size re-estimation for Part B based on Part A findings, if necessary. |
| • | In April 2026, Inhibikase announced that IMPROVE-PAH has been initiated with the recent activation of our first clinical sites in the United States, together with the enrollment of the first patient in the United States. Following the recent country approvals mentioned above, efforts to initiate clinical sites outside of the United States are now advancing. |
| • | In April 2026, Inhibikase submitted an Orphan Drug Designation (“ODD”) application to the U.S. Food and Drug Administration for IKT-001 for treatment of PAH recognizing that PAH is a high unmet medical need impacting approximately 50,000 Americans. |
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