This section highlights FDA-related milestones and regulatory updates for drugs developed by Inhibikase Therapeutics (IKT).
Over the past two years, Inhibikase Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IKT-001 and IkT-001Pro. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
IKT-001 FDA Regulatory Events
IKT-001 is a drug developed by Inhibikase Therapeutics for the following indication: Pulmonary Arterial Hypertension.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IKT-001
- Announced Date:
- April 7, 2026
- Indication:
- Pulmonary Arterial Hypertension
Announcement
Inhibikase Therapeutics, announced today that the first patient has been enrolled in the Company's pivotal Phase 3 study IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332).
AI Summary
Inhibikase Therapeutics announced that the first patient has been enrolled in its pivotal Phase 3 study, IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332). The study tests IKT-001, the Company’s investigational therapy for pulmonary arterial hypertension (PAH), and this enrollment marks the start of the late-stage trial.
The IMPROVE-PAH trial will measure pulmonary vascular resistance and other key outcome variables to evaluate whether IKT-001 improves hemodynamics and clinical results for people with PAH. As a pivotal Phase 3 study, its findings will be central to assessing the drug’s safety and effectiveness. The program will continue enrolling patients across trial sites, with subsequent data readouts and analyses planned as the study progresses.
Read Announcement- Drug:
- IKT-001
- Announced Date:
- November 20, 2025
- Indication:
- Pulmonary Arterial Hypertension
Announcement
Inhibikase Therapeutics, Inc. announced that it expects to advance IKT-001 to a global pivotal Phase 3 clinical study in PAH.
AI Summary
Inhibikase announced it expects to advance IKT-001, a prodrug of imatinib, into a global pivotal Phase 3 study called IMPROVE-PAH, planned to start in the first quarter of 2026. IKT-001 is designed to deliver imatinib’s anti-proliferative benefits in pulmonary arterial hypertension (PAH) while improving gastrointestinal tolerability and lowering treatment discontinuations. Imatinib has shown potential to improve pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD).
The adaptive Phase 3 will run in two parts: Part A is a double-blind, placebo-controlled trial of about 140 patients with a primary endpoint of PVR at Week 24; Part B will mirror Part A but enroll about 346 patients with a primary endpoint of 6MWD at Week 24. The design includes a 12-week dose-titration, uninterrupted enrollment between parts, and possible sample-size re-estimation for Part B. The study may be conducted at roughly 180 sites worldwide and could shorten the path to potential approval by about three years.
Read Announcement
IkT-001Pro FDA Regulatory Events
IkT-001Pro is a drug developed by Inhibikase Therapeutics for the following indication: Chronic Myelogenous Leukemia (CML).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IkT-001Pro
- Announced Date:
- October 9, 2024
- Indication:
- Chronic Myelogenous Leukemia (CML)
Announcement
Inhibikase Therapeutics, Inc announced the pricing of an approximately $110 million private placement financing, before deducting placement agent fees and other offering expenses.
AI Summary
Inhibikase Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced the pricing of a private placement financing of approximately $110 million before deducting placement agent fees and other offering expenses. The company plans to use the net proceeds to finance the initiation of a Phase 2b trial for its pulmonary arterial hypertension treatment, IkT-001Pro, along with supporting general corporate purposes.
The financing round was led by new investor Soleus Capital and included participation from several healthcare-focused investment funds. In connection with this financing, the company also made changes to its Board of Directors by welcoming four new directors. This move is part of Inhibikase’s broader strategy to strengthen its leadership and drive forward its clinical programs as it advances its efforts to address cardiopulmonary and neurodegenerative diseases.
Read Announcement
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