Jupiter Neurosciences, Inc. (NASDAQ:JUNS), a clinical-stage pharmaceutical company developing JOTROL^™, a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction, 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 JOTROL^™ in patients with Parkinson’s disease.

The FDA’s clearance marks a significant regulatory milestone for Jupiter, enabling the Company to begin enrollment in its exploratory Phase 2a trial designed to evaluate the safety and tolerability of JOTROL in patients with Parkinson’s, with secondary and exploratory endpoints to assess pharmacokinetics/pharmacodynamics (PK/PD) of the drug.

“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 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 advances toward trial initiation, the Company will continue its collaboration with Zina Biopharmaceuticals, LLC, which has supported trial protocol design, including pharmacokinetic and biomarker planning, and is assisting with site selection. With IND clearance in place, Jupiter expects to begin trial enrollment in early 2026.

Preclinical studies using the MPTP model of Parkinson’s disease demonstrated that JOTROL improved key motor function endpoints such as rotarod performance and grip strength, consistent with neuroprotective effects. The Company’s proprietary micellar delivery system enables JOTROL to achieve more than nine-fold higher bioavailability than traditional resveratrol, while avoiding the gastrointestinal side effects that have historically limited the compound’s therapeutic utility.

Parkinson’s disease affects over 10 million people worldwide, with no disease-modifying treatments currently available. The global Parkinson’s therapeutics market is projected to exceed $14 billion by 2030, highlighting the urgent need for novel interventions. Jupiter Neurosciences remains committed to leveraging JOTROL’s unique pharmacological advantages to address this significant unmet medical need.