FDA Places Clinical Hold on Serina Therapeutics' SER-252 Parkinson's Drug Trial
Reuters
Nov 03, 2025
FDA Places Clinical Hold on Serina Therapeutics' SER-252 Parkinson's Drug Trial
Serina Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug (IND) application for SER-252, the company's lead program for advanced Parkinson's disease. The FDA is requesting additional information regarding a commonly used excipient in the drug's formulation. The agency's feedback does not concern the active drug substance or its mechanism of action. Serina Therapeutics stated it will work quickly to address the FDA's requests and expects to receive a formal clinical-hold letter within 30 days. The company emphasized its commitment to advancing SER-252 and its broader drug development pipeline.
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