Jupiter Neurosciences, a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based platform, announced it has entered into an agreement with Catalent Pharma Solutions, LLC (“Catalent”) for the production of JOTROL softgel capsules to support Jupiter’s upcoming Phase 2a clinical trial in Parkinson’s disease.
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Under the terms of the agreement, Catalent will manufacture clinical batches of JOTROL, Jupiter’s proprietary resveratrol-based therapeutic, using an optimized softgel formulation. The production will include both active and placebo batches for the Parkinson’s study. This manufacturing initiative will be conducted under current Good Manufacturing Practices (CGMP) to meet regulatory and clinical standards.
“Securing an experienced CDMO leader like Catalent is a critical step as we advance JOTROL into clinical development for Parkinson’s disease,” said Christer Rosén, Chairman and CEO of Jupiter Neurosciences. “Catalent’s industry-leading expertise in pharmaceutical manufacturing and its ability to scale production efficiently according to a tight timeline will help us maintain momentum in our development program and support our goal of delivering innovative therapies to patients.”
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JOTROL is designed to overcome the historical challenges of resveratrol by significantly enhancing bioavailability while minimizing gastrointestinal side effects. The upcoming Phase 2a trial will evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of JOTROL in Parkinson’s patients over a three-month period.
With over 10 million people affected by Parkinson’s disease worldwide, there remains an urgent need for innovative treatments. The Parkinson’s therapeutics market is projected to exceed $14 billion by 2030. Jupiter Neurosciences continues to pursue strategic partnerships to accelerate JOTROL’s development across multiple indications, including Alzheimer’s and other neurodegenerative diseases.
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Source – globenewswire
