Jupiter Neurosciences announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to initiate a Phase 2a clinical trial of JOTROL in patients with Parkinson's disease. The FDA clearance represents a significant regulatory milestone for the clinical-stage pharmaceutical company, enabling enrollment in an exploratory Phase 2a trial designed to evaluate the safety and tolerability of JOTROL in Parkinson's patients.
Enhanced Resveratrol Platform Targets Neuroinflammation
JOTROL is a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction. 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.
"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."
Phase I Data Demonstrates Superior Bioavailability
Jupiter Neurosciences conducted a Phase I study demonstrating that JOTROL achieves over nine times higher bioavailability compared to resveratrol used in earlier clinical trials, including the Turner et al. MCI/Early Alzheimer's Disease trial and Yui et al. Friedreich's Ataxia trial. The Phase I study results were published in the Journal of Alzheimer's Disease and AAPS Open in February 2022.
Traditional resveratrol requires high plasma concentrations of approximately 300 ng/ml to be effective, achievable only with doses exceeding 3 grams using earlier resveratrol products. However, doses over 2 grams have been associated with severe gastrointestinal side effects, preventing the compound from receiving regulatory approval for any indication.
Preclinical Evidence Supports Neuroprotective Effects
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 MPTP model is a well-established preclinical model for studying Parkinson's disease pathology and potential therapeutic interventions.
Trial Design and Timeline
The exploratory Phase 2a trial will evaluate safety and tolerability of JOTROL in patients with Parkinson's disease as primary endpoints, with secondary and exploratory endpoints to assess pharmacokinetics and pharmacodynamics of the drug. Jupiter is collaborating 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.
Addressing Significant Unmet Medical Need
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 is pursuing a dual-path strategy to address neuroinflammation and promote healthy aging, advancing a therapeutic pipeline targeting central nervous system disorders and rare diseases. The company's prescription pipeline focuses broadly on CNS disorders, including indications such as Alzheimer's Disease, Mucopolysaccharidoses Type I, Friedreich's Ataxia, and MELAS, in addition to the current Phase 2a trial in Parkinson's disease.
