FDA Lifts Clinical Hold on Inhibikase Candidate for Parkinson’s Disease

The FDA has lifted a clinical hold on Inhibikase Therapeutics’ clinical trial evaluating IkT-148009, its drug candidate for treatment of Parkinson’s disease.

IkT-148009 is a small-molecule drug that targets Abl kinase activation to stop and reverse the loss of dopamine-secreting neurons in the brain and gastrointestinal tract.

The FDA placed a full clinical hold on use of the investigational drug for both diseases in November 2022 after the agency reviewed the company’s investigational new drug application for treatment of multiple system atrophy, a rare neurodegenerative disorder that leads to symptoms similar to Parkinson’s.

The company aims to begin patient enrollment in the Parkinson’s disease study by the end of the first quarter. The clinical hold remains in place for the multiple system atrophy study.