Jupiter Neurosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial of its lead candidate JOTROL™ in patients with Parkinson’s disease.
The FDA’s clearance marks a major milestone for Jupiter, allowing the company to begin enrollment in its exploratory Phase 2a study, which will evaluate the safety and tolerability of JOTROL, with secondary and exploratory endpoints focused on the drug’s pharmacokinetics and pharmacodynamics (PK/PD).
“This IND clearance from the FDA is an important step forward for Jupiter and the Parkinson’s community,” said Christer Rosén, Chairman and CEO of Jupiter Neurosciences. “JOTROL’s unique formulation has shown strong safety and bioavailability in Phase I, and preclinical data suggest potential neuroprotective and disease-modifying effects in Parkinson’s. We are proud to move this innovative therapy closer to patients.”
Jupiter’s proprietary micellar delivery system allows JOTROL to achieve over nine times higher bioavailability than traditional resveratrol, while minimizing gastrointestinal side effects. Preclinical studies using the MPTP model of Parkinson’s disease demonstrated that JOTROL improved motor function metrics such as rotarod performance and grip strength, indicating potential neuroprotective benefits.
The company will continue working with Zina Biopharmaceuticals, LLC, which is supporting trial design, pharmacokinetic analysis, biomarker development, and site selection. Jupiter expects to begin patient enrollment in early 2026.
With more than 10 million people affected by Parkinson’s globally and no disease-modifying therapies currently available, Jupiter aims to leverage JOTROL’s novel mechanism to address a critical unmet medical need. The global Parkinson’s therapeutics market is projected to surpass $14 billion by 2030, underscoring the growing demand for innovative treatments.