Serina Therapeutics Overcomes Regulatory Hurdle as FDA Clears Path for Revolutionary Parkinson's Treatment

In a significant regulatory victory that demonstrates the resilience required in biotechnology development, Serina Therapeutics announced on January 29, 2026, that the FDA has cleared its Investigational New Drug (IND) application for SER-252, an innovative therapy for advanced Parkinson's disease. The clearance marks a remarkable turnaround for the Alabama-based company, which successfully addressed regulatory concerns that had placed the program on clinical hold just months earlier.

The FDA's clearance enables Serina to proceed with regulatory and site-level activities to support initiation of a planned Phase 1b registrational clinical study evaluating SER-252 in patients with advanced Parkinson's disease. This milestone represents more than just regulatory approval; it validates a novel approach to treating one of neurology's most challenging conditions through continuous dopaminergic stimulation delivered via a revolutionary drug delivery platform.

From Setback to Success: Navigating Regulatory Challenges

The path to this clearance was not without obstacles. In November 2025, the FDA placed a clinical hold on SER-252's IND application, requesting additional information related to a commonly used excipient in the formulation. Importantly, the FDA's concerns did not relate to the active drug substance or its proposed mechanism of action, suggesting confidence in the underlying therapeutic approach.

Serina's ability to rapidly address these concerns and secure clearance within just a few months demonstrates both the company's regulatory expertise and the FDA's recognition of the significant unmet medical need in advanced Parkinson's disease. The successful resolution also reflects the agency's support for Serina's development approach under a 505(b)(2) NDA pathway, which could potentially accelerate the path to approval.

"FDA clearance of the IND is a major milestone for Serina and underscores the promise of the SER-252 program," said Steve Ledger, Chief Executive Officer of Serina Therapeutics. "As we initiate our registrational study, we will begin generating meaningful clinical data for SER-252 in patients with advanced Parkinson's disease."

Revolutionary POZ Platform Technology

What sets SER-252 apart from existing Parkinson's treatments is its foundation on Serina's proprietary POZ Platform technology. SER-252 is an investigational apomorphine therapy designed to provide continuous dopaminergic stimulation through a single or twice-weekly subcutaneous injection, representing a dramatic improvement over current treatment paradigms that require multiple daily doses.

The POZ (poly(2-oxazoline)) technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs. For Parkinson's patients, this could translate into more stable dopamine levels throughout the day, potentially reducing the motor fluctuations and dyskinesia that plague patients on current therapies.

Continuous dopaminergic stimulation has been shown to reduce the severity of motor fluctuations, including levodopa-induced dyskinesia, while enabling greater daily "on time" with reduced "off time" in advanced Parkinson's patients. Current treatments often result in peak-trough variations that contribute to the wearing-off phenomena and dyskinesia that significantly impact quality of life.

Addressing Critical Unmet Medical Need

Parkinson's disease affects over 10 million people worldwide, with advanced disease representing a particularly challenging treatment scenario. As the disease progresses, patients typically experience motor fluctuations where the beneficial effects of levodopa become shorter-lasting and less predictable. These fluctuations can be severely disabling, leaving patients alternating between periods of good mobility and periods of significant impairment.

The global Parkinson's disease therapeutics market was valued at approximately $6.59 billion in 2024 and is expected to grow significantly, driven by an aging population and increasing disease awareness. However, treatment options for advanced disease remain limited, with many patients eventually requiring complex pump-based therapies or surgical interventions.

SER-252's approach could potentially fill this gap by providing the benefits of continuous dopaminergic stimulation through a simple subcutaneous injection, eliminating the need for complex delivery systems or surgical procedures. The therapy leverages Enable Injections' enFuse wearable drug delivery platform to enhance patient comfort and convenience.

Strategic Path Forward

With FDA clearance secured, Serina is now advancing Phase 1b clinical site start-up and regulatory activities in Australia to support the global registrational program. The SER-252-1b study is designed as a randomized, double-blind, placebo-controlled Phase 1b trial with single-ascending-dose and multiple-ascending-dose components in adults with Parkinson's disease and motor fluctuations.

The study will evaluate safety, tolerability, and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures including motor scores and structured motor-state assessments. This comprehensive approach should provide the data needed to support advancement to later-stage trials and eventual regulatory approval.

Beyond SER-252, Serina continues to advance its broader POZ Platform-based pipeline, including SER-270 for tardive dyskinesia and platform applications in RNA therapeutics and antibody-drug conjugates. The successful navigation of regulatory challenges with SER-252 validates the platform's potential and positions Serina as an emerging leader in precision drug delivery.

For the millions of patients worldwide living with advanced Parkinson's disease, SER-252 represents hope for a treatment that could provide more consistent symptom control with improved convenience and quality of life. As Serina advances toward clinical trials, the medical community will be watching closely to see whether this innovative approach can deliver on its promise to transform Parkinson's care.