Serina Therapeutics announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for SER‑252, a POZ‑apomorphine formulation designed to provide continuous dopaminergic stimulation in patients with advanced Parkinson’s disease.
The clearance removes a major regulatory hurdle and allows Serina to initiate a Phase 1b registrational study. It also confirms the company’s strategy to pursue a 505(b)(2) New Drug Application, a pathway that leverages existing safety and efficacy data to shorten development timelines and reduce costs compared with a traditional 505(b)(1) application.
Serina’s regulatory journey included a clinical hold issued on November 3, 2025 over concerns about the excipient trehalose. The company submitted a complete response on December 3, 2025, and the hold was lifted before the IND clearance, demonstrating its ability to resolve FDA concerns and advance the program.
The Parkinson’s disease market is projected to grow from $5.65 billion in 2024 to $7.58 billion by 2030, driven by an aging population and unmet needs for motor‑complication management. SER‑252’s twice‑weekly subcutaneous injection aims to address these gaps by delivering sustained dopaminergic stimulation with a less invasive regimen than current therapies.
CEO Steve Ledger said, “FDA clearance of the IND is a major milestone for Serina and underscores the promise of the SER‑252 program. As we initiate our registrational study, we will begin generating meaningful clinical data for patients with advanced Parkinson’s disease, positioning SER‑252 on a clear and efficient path toward addressing a significant unmet medical need.”
The announcement was well received by investors, reflecting confidence in Serina’s regulatory progress and the potential of its POZ platform to transform long‑acting neurological therapeutics.
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