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Serina Therapeutics Submits Complete Response to FDA Clinical Hold Letter for SER-252 Program

SER
  • Serina Therapeutics submitted a complete response to the FDA on December 9, 2025, regarding the clinical hold on its lead candidate SER-252 for advanced Parkinson's disease.
  • The clinical hold was issued on November 25, 2025, pending additional data regarding a formulation excipient, specifically trehalose.
  • The FDA's concerns do not involve the apomorphine active drug substance, the enFuse delivery device, or the 505(b)(2) NDA pathway.
  • The company's response includes a detailed data package supporting the use of trehalose as a subcutaneous excipient, including comparative data & nonclinical analyses.
  • A revised protocol for the single ascending dose (SAD) phase of the SER-252-1b trial was submitted to initiate the study.
  • Global site start-up activities are ongoing in Australia & other regions, with the first-patient-in targeted for Q1 2026.
  • Dosing for the Phase 1b registrational study cannot begin until the FDA lifts the clinical hold & customary regulatory approvals are obtained.