FDA Clears Phase 2a Clinical Trial to Test JOTROL in Patients With Parkinson Disease

According to a recent announcement from Jupiter Neurosciences, Inc., the FDA has cleared the company’s investigational New Drug (IND) application to initiate a phase 2a clinical trial of JOTROL ™ in patients with Parkinson Disease (PD). JOTROL, an investigational treatment, is a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction.¹

“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, said in a statement.¹ “JOTROL’s unique formulation has demonstrated strong safety and bioavailability data in Phase 1 and preclinical evidence suggests neuroprotective benefits that may translate into disease-modifying potential in Parkinson. We are proud to advance this innovative program and are now one step closer to initiating patient dosing.”

The impending phase 2a trial is designed to evaluate the safety and tolerability of JOTROL in patients with PD, with secondary and exploratory endpoints to assess pharmacokinetics/pharmacodynamics (PK/PD) of the drug. The Phase 2a evaluation comes after a phase 1 trial that provided favorable drug absorption results, namely JOTROL’s 9 times greater bioavailability when compared to resveratrol used in earlier clinical trials. According to the company, the findings of that phase 1 study will be cross-referenced in all upcoming JOTROL trials.

Senior author Marshall Hayward, PhD, director and chief scientific officer at Jupiter Neurosciences, Inc., and his colleagues conducted the phase 1 study of JOTROL. The trial was a first-in-human (FIH) study that evaluated the drug’s bioavailability following ascending oral doses up to 700 mg. After a single 500-mg dose, researchers reported a maximum concentration (Cmax) of 455 ng/mL, compared with 85 ng/mL following a 1-g encapsulated dose (Turner et al., Neurology 2015), and a Cmax of 1942 ng/mL after a 2.5-g micronized dose (Howells et al., Cancer Prev Res 2011). Increases area under the curve (AUC) and Cmax were found to be greater than dose-proportional, suggesting enhanced absorption with JOTROL.

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“Based on the power model analysis, the resveratrol exposures (AUC and Cmax) increased with increasing dose; however, this increase appeared to be higher than dose-proportional for AUC_0-t and Cmax,” study authors noted.² “There is a 1.4- to 21-fold increase in the Cmax with JOTROL, with a concomitant decrease in the amount of dose-related material in the gut. What is also seen is a high amount of variability among different dose forms and within and between studies. A standardized highly bioavailable and well-tolerated dose form is needed for further clinical development, but based on the results of this study, the product development of JOTROLTM is a major step in that direction.”

Prior to phase 1, preclinical studies using the MPTP model of PD demonstrated that JOTROL improved key motor function endpoints such as rotarod performance and grip strength, consistent with neuroprotective effects. According to Jupiter, the company’s proprietary micellar delivery system enables JOTROL to achieve more than 9-fold higher bioavailability than traditional resveratrol, while avoiding the gastrointestinal side effects that have historically limited the compound’s therapeutic utility.

JOTROL is a micellar 10% resveratrol solubilization formulation that is thought to increase bioavailability of resveratrol via lymphatic system absorption. Jupiter Neurosciences is pursuing the use of resveratrol in mucopolysaccharidosis type 1 (MPS 1), Friedreich ataxia, and Alzheimer disease/mild cognitive impairment.

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REFERANCES
1. Jupiter Neurosciences Receives FDA Clearance of IND Application to Initiate Phase 2a Clinical Trial of JOTROL™ in Parkinson’s Disease. Jupiter Neurosciences, Inc. News Release. November 5, 2025. Accessed November 10, 2025. https://www.globenewswire.com/news-release/2025/11/05/3181489/0/en/Jupiter-Neurosciences-Receives-FDA-Clearance-of-IND-Application-to-Initiate-Phase-2a-Clinical-Trial-of-JOTROL-in-Parkinson-s-Disease.html
2. Kemper C, Benham D, Brothers S, et al. Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL ™). AAPS Open. 2022;8(1):11. doi:10.1186/s41120-022-00058-1