Serina Therapeutics announced that the U.S. Food & Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug (IND) application for the therapy candidate SER‑252, intended for advanced Parkinson’s disease. According to the company, the regulatory hold is based on a request for additional information regarding a commonly used excipient in the formulation, and does not involve the active drug substance or its mechanism of action.
Serina said that it expects to receive the formal clinical-hold letter from the FDA within 30 days and will provide a further update once discussions and alignment of next steps are completed.
Previously, the company had received FDA feedback supporting SER-252’s advancement under a 505(b)(2) NDA pathway, which signalled regulatory alignment for its registrational trial design.
Serina claims the programme remains an important part of its broader pipeline enabled by its proprietary POZ Platform, and the company said that efforts are underway to promptly address the FDA’s requests while continuing to advance other small-molecule and modality-based programmes.
This development marks a setback in the timing of SER-252’s progression toward human trials in both Australia and the U.S., where patient dosing and enrolment were earlier slated to begin later in 2025 and early 2026 respectively.
