Jupiter Neurosciences Receives FDA Clearance of IND Application to Initiate Phase 2a Clinical Trial of JOTROL™ in Parkinson's Disease

Jupiter, Florida, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ:JUNS), a clinical-stage pharmaceutical company developing JOTROL^™, a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction, today 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.

The FDA's clearance marks a significant regulatory milestone for Jupiter, enabling the Company to begin enrollment in its exploratory Phase 2a trial designed to evaluate the safety and tolerability of JOTROL in patients with Parkinson's, with secondary and exploratory endpoints to assess pharmacokinetics/pharmacodynamics (PK/PD) of the drug.

"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. We are proud to advance this innovative program and are now one step closer to initiating patient dosing."

As Jupiter advances toward trial initiation, the Company will continue its collaboration 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.

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 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.

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 remains committed to leveraging JOTROL's unique pharmacological advantages to address this significant unmet medical need.

About Jupiter Neurosciences, Inc.

Jupiter Neurosciences is a clinical-stage pharmaceutical company pursuing a dual-path strategy to address neuroinflammation and promote healthy aging. The Company is advancing a therapeutic pipeline targeting central nervous system (CNS) disorders and rare diseases, while also expanding into the consumer longevity market with its Nugevia product line. Both efforts are powered by JOTROL^™, Jupiter's proprietary, enhanced resveratrol formulation that has demonstrated significantly improved bioavailability. Nugevia brings clinical-grade science to the supplement space, supporting mental clarity, skin health, and mitochondrial function. The Company's prescription pipeline is focused broadly on CNS disorders, presently with a Phase IIa in Parkinson's disease, including indications such as Alzheimer's Disease, Mucopolysaccharidoses Type I, Friedreich's Ataxia, and MELAS. More information may be found on the Company's website www.jupiterneurosciences.com.

About JOTROL

Resveratrol is one of the world's most extensively researched molecules. Thorough evaluation has shown that for the compound to be effective, it requires a high C-Max (~300 ng/ml of resveratrol in plasma), achievable only with doses exceeding 3 grams using earlier resveratrol products. Poor bioavailability has been a well-documented issue with resveratrol. Doses over 2 grams have been associated with severe gastrointestinal (GI) side effects, which have prevented the compound from receiving regulatory approval for any indication.

Jupiter Neurosciences (JUNS) conducted a Phase I study demonstrating that JOTROL^™ achieves over nine times higher bioavailability compared to resveratrol used in earlier clinical trials (e.g., Turner et al., MCI/Early Alzheimer's Disease trial, and Yui et al., Friedreich's Ataxia trial). The results of this Phase I study, which will be cross-referenced in all upcoming JOTROL^™ trials, were published in the Journal of Alzheimer's Disease and AAPS Open in February 2022. JUNS is now advancing JOTROL^™ toward a Phase IIa trial in Parkinson's Disease.

In addition to its therapeutic applications, JOTROL^™ serves as the foundation for Jupiter's Nugevia consumer supplement line. By leveraging the same clinically validated delivery technology, Nugevia introduces pharmaceutical-grade bioavailability into the wellness space, offering targeted support for cognitive health, skin vitality, and cellular energy.

FORWARD-LOOKING STATEMENTS

Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company's current expectations, including the Company's ability to generate revenues from the sale of JOTROL products to consumers through the DTC model. Investors can find many (but not all) of these statements by the use of words such as "approximates," "believes," "hopes," "expects," "anticipates," "estimates," "projects," "intends," "plans," "will," "would," "should," "could," "may" or other similar expressions. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to read the risk factors contained in the Company's final prospectus and other reports it files with the SEC before making any investment decisions regarding the Company's securities. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.

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