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-001Pro and Risvodetinib. 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-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
Risvodetinib FDA Regulatory Events
Risvodetinib is a drug developed by Inhibikase Therapeutics for the following indication: Multiple System Atrophy.
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:
- Risvodetinib
- Announced Date:
- June 17, 2024
- Indication:
- Multiple System Atrophy
Announcement
Inhibikase Therapeutics, Inc announced the company has completed enrollment in the Phase 2 ‘201' trial evaluating the safety and tolerability of risvodetinib ("risvo"), a potent selective c-Abl inhibitor, for treatment in untreated Parkinson's patients.
AI Summary
Inhibikase Therapeutics, Inc. has successfully completed enrollment in its Phase 2 “201” trial assessing risvodetinib (risvo), a potent selective c-Abl inhibitor, for the treatment of untreated Parkinson’s disease. The trial is a 12-week, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and early signs of efficacy of risvo. A total of 120 participants from 32 U.S. sites have been enrolled, with plans to randomize 126 patients, ensuring that screened participants are not excluded. Sixty-nine patients have already completed the dosing period, and only mild to moderate adverse events have been observed so far. This milestone reflects the hard work of Inhibikase’s team and their commitment to advancing potential disease-modifying therapies for Parkinson’s disease. The company expects to report trial results in the fourth quarter of 2024, setting the stage for future pivotal Phase 3 trials.
Read Announcement- Drug:
- Risvodetinib
- Announced Date:
- June 17, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Multiple System Atrophy
Announcement
Inhibikase Therapeutics, Inc. announced that The company expects to report trial results in the fourth quarter of 2024.
AI Summary
Inhibikase Therapeutics, Inc. announced that enrollment is complete for its Phase 2 ‘201 trial, evaluating the safety and tolerability of risvodetinib in patients with untreated Parkinson’s disease. The trial, which tests a selective c-Abl inhibitor, involved 120 participants at 32 study sites across the United States, marking an important step in the company’s mission to develop treatments that could slow down disease progression.
The company expects to report trial results in the fourth quarter of 2024. This update sets the stage for future discussions with the FDA about advancing to pivotal Phase 3 trials. The anticipated results are highly awaited as they will help determine if risvodetinib can offer a new approach to treating Parkinson’s and potentially other neurodegenerative disorders.
Read Announcement
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