Jupiter Neurosciences (JUNS) FDA Approvals

Jupiter Neurosciences' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Jupiter Neurosciences (JUNS). Over the past two years, Jupiter Neurosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as JOTROL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

JOTROL FDA Regulatory Timeline and Events

JOTROL is a drug developed by Jupiter Neurosciences for the following indication: For Parkinson's disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Enrollment Update - May 27,2026

Phase 2a

• Drug: JOTROL
• Announced Date: May 27, 2026
• Indication: For Parkinson's disease.

Jupiter Neurosciences, Inc announced that patient enrollment is now underway in its Phase 2a RESET clinical trial (NCT07592767) for JOTROL™ (investigational trans-resveratrol micellar formulation) in Parkinson's Disease (PD), with first patient dosing expected in the near term.

Jupiter Neurosciences, Inc. said patient enrollment has started in its Phase 2a RESET clinical trial, called RESET, for JOTROL™, an investigational oral trans-resveratrol micellar formulation being studied in Parkinson’s disease. First patient dosing is expected soon. The company says this is a major step after years of research and development and represents its biggest clinical milestone so far.

The trial is being led by experts at Georgetown University Medical Center and is aimed at testing whether JOTROL can help in a disease area where no disease-modifying treatments are currently available. Jupiter also noted that the study is active on ClinicalTrials.gov and includes multiple study centers in the Washington, D.C. area and nearby states. Company leaders said they are eager to share data as the trial moves forward.

FDA Clearance - November 5,2025

IND

• Drug: JOTROL
• Announced Date: November 5, 2025
• Indication: For Parkinson's disease.

Jupiter Neurosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial of JOTROL™ in patients with Parkinson's disease.

Jupiter Neurosciences, Inc. announced that the FDA has cleared its IND application for a Phase 2a clinical trial of JOTROL™ in Parkinson’s disease patients. This regulatory milestone lets Jupiter start enrolling participants in early 2026. The study will assess safety and tolerability as primary endpoints and will include pharmacokinetic and pharmacodynamic measures as secondary and exploratory endpoints. Jupiter is working with Zina Biopharmaceuticals on trial protocol design and site selection.

JOTROL™ is a patented resveratrol-based therapy that targets neuroinflammation and mitochondrial dysfunction. Preclinical studies showed improved motor functions in Parkinson’s models, and earlier data demonstrated strong safety and over ninefold higher bioavailability compared to traditional resveratrol. Jupiter hopes this trial will reveal disease-modifying potential and advance treatment options for over 10 million people living with Parkinson’s worldwide.

Provided Update - February 3,2025

• Drug: JOTROL
• Announced Date: February 3, 2025
• Indication: For Parkinson's disease.

Jupiter Neurosciences, Inc. 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.

Jupiter Neurosciences, Inc. has partnered with Catalent Pharma Solutions for the production of its JOTROL™ softgel capsules, which are being prepared to support an upcoming Phase 2a clinical trial in Parkinson’s disease. Under the agreement, Catalent will manufacture clinical batches—both active and placebo—using an optimized softgel formulation designed to enhance the bioavailability of resveratrol while reducing gastrointestinal side effects. This manufacturing process will adhere to current Good Manufacturing Practices (CGMP) standards, ensuring it meets the regulatory requirements for the clinical trial. The collaboration with a leading contract development and manufacturing organization like Catalent is a crucial step for Jupiter as it works to advance JOTROL into the clinical stage, offering hope for improved treatment options in Parkinson’s disease therapy.