Jupiter Neurosciences Receives U.S. FDA Clearance to Begin Phase 2a Trial of JOTROL™ for Parkinson’s Disease
Thursday, November 06, 2025
Jupiter Neurosciences, Inc, a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to start a Phase 2a clinical trial in patients with Parkinson’s disease.
This clearance allows Jupiter to begin enrolment for its exploratory Phase 2a study, which will assess the safety and tolerability of JOTROL™, along with secondary and exploratory endpoints evaluating its pharmacokinetics and pharmacodynamics (PK/PD).
The company will continue its collaboration with Zina Biopharmaceuticals, LLC, which has supported the trial protocol design, pharmacokinetic and biomarker planning, and site selection. Patient enrolment for the study is expected to begin in early 2026.
Preclinical studies using the MPTP model of Parkinson’s disease have shown that JOTROL™ improved key motor functions such as grip strength and rotarod performance, consistent with neuroprotective activity. The therapy uses a proprietary micellar delivery system that achieves over nine times higher bioavailability than standard resveratrol while reducing gastrointestinal side effects.
Parkinson’s disease affects more than 10 million people globally and currently lacks disease-modifying treatments. With the global Parkinson’s therapeutics market expected to surpass USD 14 billion by 2030, Jupiter aims to advance JOTROL™ as a potential new therapeutic option to address this pressing unmet medical need.
Source: globenewswire.com
