Jupiter Neurosciences Receives FDA Clearance to Begin Phase 2a Trial of JOTROL™ in Parkinson’s Disease
Thursday, November 06, 2025
Jupiter Neurosciences has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 2a clinical study of JOTROL™ in patients with Parkinson’s disease.
JOTROL™ is a patented resveratrol-based therapeutic platform developed to target neuroinflammation and mitochondrial dysfunction. The formulation has demonstrated strong safety and bioavailability in Phase I studies. Preclinical research using a Parkinson’s disease model showed improvements in motor performance and grip strength, supporting its potential neuroprotective benefits.
Parkinson’s disease affects more than 10 million people globally, with no approved treatments that modify the course of the disease. The global Parkinson’s therapeutics market is projected to exceed USD 14 billion by 2030, underlining the need for new and effective therapies.
The FDA approval represents a key regulatory milestone, enabling the company to begin enrolment in the study, which will evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of JOTROL™. Trial enrolment is expected to commence in early 2026.
The company is working with Zina Biopharmaceuticals, LLC on the clinical protocol design, biomarker planning, and site selection to advance the study. JOTROL’s proprietary micellar delivery system enables greater bioavailability compared to conventional resveratrol formulations while reducing gastrointestinal side effects.
Source: globenewswire.com
