First Patient Dosed with JOTROL™ Marks Major Clinical Milestone for Jupiter Neurosciences’
Phase 2a Study Evaluating Safety, Pharmacokinetics and Biomarkers of JOTROL™ in Patients with Parkinson’s Disease
Tungsten Advisors has been retained to identify strategic options to monetize Jupiter’s existing clinical development programs via corporate partners and explore other strategic options for a transaction to maximize shareholder value
Jupiter, FL, Oct. 06, 2026 (GLOBE NEWSWIRE) — Jupiter Neurosciences, Inc. (NASDAQ: JUNS), a clinical-stage biopharmaceutical company developing investigational therapies for neurodegenerative diseases, today announced that the first patient has been dosed in the company’s Phase 2a RESET clinical trial evaluating JOTROL™ in patients with Parkinson’s disease (PD).
The dosing of the first patient represents an important clinical milestone for Jupiter and marks the transition of JOTROL™ into Phase 2a clinical evaluation in patients with Parkinson’s disease. The RESET study (NCT07592767) is a multicenter, randomized, double-blind, placebo-controlled Phase 2a clinical trial designed to evaluate the safety, tolerability, pharmacokinetics and biomarker effects of JOTROL™, Jupiter’s investigational, proprietary micellar formulation of trans-resveratrol.
“Dosing the first patient in RESET is a significant milestone for Jupiter and the culmination of years of scientific, regulatory and clinical development work,” said Christer Rosén, Chief Executive Officer of Jupiter Neurosciences. “We believe that JOTROL has the potential to address biological pathways implicated in Parkinson’s disease, including mitochondrial dysfunction, oxidative stress and neuroinflammation. With patient dosing now underway, we look forward to advancing enrollment and generating clinical data that will help us evaluate JOTROL’s potential in this significant area of unmet medical need.”
RESET is expected to enroll approximately 30 patients with Parkinson’s disease who will be randomized 1:1:1 to receive one of two dose levels of JOTROL™ or placebo. Study treatment will be administered orally for 12 weeks. The trial’s primary objectives include assessment of safety, tolerability and pharmacokinetics, including evaluation of JOTROL™ exposure in plasma and cerebrospinal fluid. Secondary and exploratory assessments include biomarkers associated with energy metabolism, inflammation and Parkinson’s disease, as well as clinical outcome measures.
“The first patient dosed in RESET represents an important step in translating the scientific rationale for JOTROL into a clinical study in people living with Parkinson’s disease,” said the study’s principal investigator Fernando L. Pagan, MD, professor of neurology at Georgetown University School of Medicine and Vice Chairman of the Department of Neurology. Georgetown University is the study sponsor. “This study is designed to provide important information regarding JOTROL’s safety, pharmacokinetics and biological activity in Parkinson’s disease and to help inform the future clinical development of the program.”
JOTROL™ is designed to overcome limitations associated with the bioavailability of conventional resveratrol. In a completed Phase 1 study in healthy volunteers, JOTROL™ demonstrated increased systemic exposure to resveratrol and measurable cerebrospinal fluid concentrations. The Phase 1 study reported no serious adverse events. Preclinical studies in a model of Parkinson’s disease also demonstrated neuroprotective effects, including improvements in measures of motor function. These findings supported advancement of JOTROL™ into the RESET Phase 2a study.
“Moving from enrollment to dosing our first patient is a defining moment for Jupiter and, importantly, puts us in a position to begin generating patient data from our lead clinical program,” said Alison Silva, President and Chief Business Officer of Jupiter Neurosciences. “We are grateful to the patients, investigators, clinical sites and collaborators participating in RESET. We remain focused on efficient execution of the study and look forward to providing updates as the program progresses.”
As the company continues to enroll patients in the RESET trial, it has also initiated a formal process to explore and evaluate strategic options to maximize shareholder value. These options may include the sale or licensing of clinical and other assets, strategic partnerships, business combinations, or other corporate transactions.
Jupiter has engaged Tungsten Advisors as the company’s strategic advisor. There can be no assurance that this process will result in any transaction. Jupiter does not intend to provide updates regarding the process unless and until its Board of Directors approves a specific transaction or the Company otherwise determines that disclosure is appropriate or required.
About Parkinson’s Disease Market
- 1.1 million U.S. patients living with Parkinson’s Disease https://www.parkinson.org/understanding-parkinsons/statistics
- 90,000 new U.S. diagnoses annually; 1.2 million U.S. patients projected by 2030 https://www.parkinson.org/understanding-parkinsons/statistics
- $82.2 billion annual U.S. economic burden of Parkinson’s Disease https://www.parkinson.org/understanding-parkinsons/statistics
- ~90% of PD patients are Medicare-enrolled https://data.cms.gov/summary-statistics-on-beneficiary-enrollment
- No disease-modifying therapies currently approved for PD; multiple investigational candidates are in active development by other companies https://www.accessdata.fda.gov/scripts/cder/daf
- Global PD treatment market: $5.65B (2024) → $7.58B (2030), CAGR 5.04% https://www.grandviewresearch.com/industry-analysis/parkinsons-disease-drugs-market
- Global prevalence: >10 million patients https://doi.org/10.1016/S1474-4422(18)30295-3
About the RESET Trial
RESET (RESvEraTrol in Parkinson’s Disease) is a multicenter, randomized, double-blind, placebo-controlled Phase 2a clinical trial evaluating JOTROL™ in approximately 30 patients with Parkinson’s disease. Participants are randomized to receive one of two doses of JOTROL™ or placebo over a 12-week treatment period.
The study is designed primarily to evaluate safety, tolerability and pharmacokinetics and will also examine pharmacodynamic and disease-relevant biomarkers, including measures associated with mitochondrial function, energy metabolism and inflammation. Exploratory clinical assessments are intended to provide additional information to inform the design of future JOTROL™ clinical studies. Additional information regarding RESET is available at ClinicalTrials.gov under identifier NCT07592767. Dr. Charbel Moussa, a sub-investigator on this study at Georgetown University, has financial interests related to Jupiter Neurosciences.
About JOTROL™
JOTROL™ is Jupiter Neurosciences’ proprietary and patented micellar formulation of trans-resveratrol designed to improve the bioavailability of resveratrol. Resveratrol has been extensively studied for its potential effects on biological pathways associated with oxidative stress, inflammation and mitochondrial function. Jupiter is developing JOTROL™ as an investigational therapeutic candidate for neurodegenerative and rare diseases.
JOTROL™ is an investigational drug candidate and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority. Its safety and efficacy for the treatment of Parkinson’s disease or any other disease have not been established.
About Jupiter Neurosciences, Inc.
Jupiter Neurosciences, Inc. (NASDAQ: JUNS) is a clinical-stage biopharmaceutical company advancing a therapeutic pipeline targeting central nervous system disorders and neuroinflammation. The Company’s lead program, JOTROLTM – a proprietary, enhanced bioavailability resveratrol formulation – is currently in a Phase 2a clinical trial for Parkinson’s disease. JUNS also commercializes NugeviaTM, a consumer longevity supplement. Additionally, the Company’s pipeline includes ALA-002, a next-generation, patented psychedelic new chemical entity (NCE) recently in-licensed from PharmAla Biotech Holdings. For more information, please visit www.jupiterneurosciences.com.
Forward-Looking Statements
Statements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements include, without limitation, statements regarding the company’s pursuit of strategic options; patient enrolment and dosing timelines for the Phase 2a RESET trial; expected study completion dates; expected development timelines; and potential regulatory pathways. These forward-looking statements are often indicated by terms such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Jupiter’s actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, that clinical trials may not demonstrate adequate safety or tolerability; enrolment may be slower than anticipated; preliminary data may not be predictive of future results; the company’s inability to identify or consummate strategic opportunities on the terms contemplated or at all; and other risks, uncertainties and other factors described under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed on April 1, 2026 and any subsequent quarterly reports. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements. Investors are cautioned not to place undue reliance on forward-looking statements. We assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Investor Relations Contact
Jupiter Neurosciences, Inc.
Christer Rosen, Chairman & Chief Executive Officer
ir@jupiterneurosciences.com
