Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company, which engages in developing protein kinase inhibitor therapeutics to modify the course of Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases. It also focuses on neurodegeneration and its lead program IkT-148009, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain as well as other diseases that arise from Ableson Tyrosine Kinases. The company was founded by Milton H. Werner in September 2008 and is headquartered in Atlanta, GA.
Clinical Trials
8
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2008
Completed
5
62.5%
Not yet recruiting
1
12.5%
Recruiting
1
12.5%
Withdrawn
1
12.5%
No approval data available
- Inhibikase Therapeutics has enrolled the first patient in its pivotal Phase 3 IMPROVE-PAH study evaluating IKT-001, a novel oral prodrug of imatinib designed to reduce gastrointestinal side effects in pulmonary arterial hypertension patients. - The global two-part adaptive trial will assess approximately 486 patients across 180 sites worldwide, with Part A focusing on pulmonary vascular resistance changes and Part B measuring 6-minute walk distance improvements. - The study incorporates a 12-week dose-titration phase and adaptive design features that could accelerate the timeline to potential NDA filing for this orphan indication affecting approximately 50,000 Americans. - Clinical experts emphasize the continued need for novel antiproliferative agents in PAH treatment, as many patients experience disease progression despite currently available therapies.
- The global pulmonary arterial hypertension pipeline comprises over 55 companies developing 55+ therapeutic candidates across all clinical phases, representing significant industry investment in this rare disease. - Merck's WINREVAIR (sotatercept-csrk) demonstrated a 76% reduction in relative risk of major morbidity and mortality events in high-risk PAH patients during Phase 3 ZENITH trial results. - Recent regulatory milestones include FDA Fast Track designation for Cereno Scientific's CS1 and IND clearance for VASTHERA's VTB-10, highlighting accelerated development pathways for novel PAH therapies. - AllRock Bio secured $50 million in Series A funding to advance ROC-101, a first-in-class pan-ROCK inhibitor, into Phase 2 trials for PAH and pulmonary hypertension associated with interstitial lung disease.
- Inhibikase Therapeutics will advance IKT-001, a novel prodrug of imatinib mesylate, directly to a global Phase 3 study for pulmonary arterial hypertension, skipping the planned Phase 2b trial. - The IMPROVE-PAH study will use an adaptive two-part design with 140 patients in Part A and 346 patients in Part B, initiating in the first quarter of 2026 across approximately 180 global sites. - This single pivotal study approach accelerates the potential FDA approval timeline by approximately three years compared to the original development plan. - IKT-001 is engineered to realize the therapeutic potential of imatinib in PAH while addressing the high discontinuation rates that impacted previous imatinib studies.
- Inhibikase Therapeutics discontinues development of risvodetinib for Parkinson's disease after Phase II trial fails to show significant efficacy despite meeting safety endpoints. - While the drug showed modest improvements in specific measures, including a 1.41-point improvement in MDS-UPDRS Part 2 scores at 100mg dosage, it failed to meet the primary functional endpoints. - The company will pivot to focus on IkT-001Pro for pulmonary arterial hypertension, marking another setback in the challenging landscape of Parkinson's drug development.
- Inhibikase Therapeutics has completed enrollment of 120 participants across 32 U.S. sites in its Phase 2 '201' trial evaluating risvodetinib for untreated Parkinson's disease, with results expected in Q4 2024. - The company is expanding its therapeutic pipeline, including redirecting IkT-001Pro development toward Pulmonary Arterial Hypertension (PAH), with an IND application planned for early Q3 2024. - Inhibikase anticipates advancing multiple late-stage ready assets across its therapeutic pipeline in 2025, including pursuing an End of Phase 2 discussion with the FDA for risvodetinib by the end of 2024.
