Inhibikase: FDA Issues Clinical Hold On IkT-148009 Programs - Quick Facts

(RTTNews) - Inhibikase Therapeutics, Inc. (IKT) announced the FDA has reviewed its Investigational New Drug application for IkT-148009 for the treatment of Multiple Systems Atrophy and has issued a clinical hold on the IkT-148009 201 program in Parkinson's disease and the use of IkT-148009 in Multiple Systems Atrophy. The FDA will provide an official clinical hold letter to the company within 30 days.

"We have not seen any serious adverse events in the ongoing 201 trial. Given the safety, tolerability and pharmacokinetics data observed in clinical trials with IkT-148009 to date, we are actively working with the FDA to understand the agency's concerns and to resolve them as soon as possible," Milton Werner, CEO, said.

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