Jupiter Neurosciences Receives FDA Clearance To Begin Phase 2a Clinical Trial Of JOTROL™ For The Treatment Of Parkinson’s Disease

Jupiter Neurosciences, Inc., a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to begin a Phase 2a clinical trial of JOTROL™ in patients with Parkinson’s disease.

The FDA’s clearance represents a major regulatory milestone for Jupiter Neurosciences, allowing the company to initiate enrollment for its exploratory Phase 2a study. The trial is designed to evaluate the safety and tolerability of JOTROL in Parkinson’s patients, with secondary and exploratory endpoints focused on pharmacokinetic and pharmacodynamic (PK/PD) assessments to better understand the drug’s clinical profile.

Christer Rosén, Chairman and Chief Executive Officer of Jupiter Neurosciences, expressed optimism about this development, stating, “This IND clearance from the FDA is an important step forward for Jupiter and the Parkinson’s community. JOTROL’s unique formulation has demonstrated strong safety and bioavailability data in Phase I, and preclinical evidence suggests neuroprotective benefits that may translate into disease-modifying potential in Parkinson’s. We are proud to advance this innovative program and are now one step closer to initiating patient dosing.”

As Jupiter moves toward the start of the clinical trial, the company will continue collaborating with Zina Biopharmaceuticals, LLC, which has contributed to trial protocol design, including pharmacokinetic and biomarker strategy, and is assisting with site selection. With the IND now cleared, Jupiter plans to begin patient enrollment in early 2026.

Preclinical studies using the MPTP model of Parkinson’s disease demonstrated that JOTROL improved key motor function parameters such as rotarod performance and grip strength, indicating neuroprotective effects. The compound’s proprietary micellar delivery system provides more than nine-fold higher bioavailability compared to traditional resveratrol formulations, while minimizing gastrointestinal side effects that have previously limited resveratrol’s therapeutic use.

Parkinson’s disease affects over 10 million people globally and remains without any disease-modifying treatments. The worldwide market for Parkinson’s therapeutics is expected to exceed $14 billion by 2030, underscoring the urgent need for new and effective therapies. By advancing JOTROL into clinical development, Jupiter Neurosciences aims to leverage its unique pharmacological platform to address this substantial unmet medical need and offer hope to patients living with Parkinson’s disease.