Jupiter Neurosciences Announces Patient Enrollment Underway in Phase 2a RESET Trial in Parkinson's Disease

Investigational Oral Candidate JOTROL^™ Addresses a Parkinson's Disease Market with No Current Disease-modifying Therapies Available

Jupiter, FL, May 27, 2026 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ:JUNS), a clinical-stage biopharmaceutical company developing investigational therapies for neurodegenerative diseases, today 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.

Parkinson's Disease affects an estimated 1.1 million people in the United States, with roughly 90,000 new diagnoses annually, and carries an estimated annual U.S. economic burden of $82.2 billion. The global PD treatment market was valued at $5.65 billion in 2024 and is projected to reach $7.58 billion by 2030, growing at a CAGR of about 5.0%. Despite decades of research, no disease-modifying therapies have been approved for PD to date. JOTROL™ is an investigational drug candidate that has not been approved by the FDA or any regulatory authority. It is currently being evaluated for its potential to target underlying biological drivers of neurodegeneration.

"Despite advances in symptomatic management, there remains a significant unmet need for therapies that may address the underlying biological drivers of Parkinson's disease. We believe JOTROL^™'s enhanced CNS exposure and mechanistic profile position it as a potentially differentiated therapeutic candidate for neurodegenerative disorders characterized by oxidative stress, mitochondrial dysfunction and chronic neuroinflammation."

— Charbel Moussa, MBBS, PhD, Professor of Neurology and Director of the Translational Therapeutics Program, Georgetown University Medical Center; Coordinating Principal Investigator, RESET Study

"The global Parkinson's Disease treatment market — currently valued at $5.65 billion and growing at a 5.04% CAGR — represents a significant and expanding unmet need that Jupiter Neurosciences is working to address with JOTROL^™. With enrollment now underway in the Phase 2a RESET trial we have reached a critical operational milestone. We look forward to generating the clinical data needed to evaluate JOTROL^™'s potential and to serve patients, providers, and the broader scientific community."

— Christer Rosén, Chief Executive Officer, Jupiter Neurosciences, Inc. (NASDAQ:JUNS)

"The initiation of enrolment in the Phase 2a RESET trial marks the culmination of 10 years of research and development at Jupiter and is our largest clinical milestone to date. I echo the enthusiasm of my colleagues, thank all our collaborators contributing to this accomplishment and look forward to reporting out data as the trial progresses."

— Alison Silva, President & Chief Business Officer, Jupiter Neurosciences, Inc. (NASDAQ:JUNS)

Clinical Trial Details

Jupiter's RESET (RESvEraTrol in Parkinson's Disease) is active on www.clinicaltrials.gov, details here:

Study Details | NCT07592767 | RESvEraTrol in Parkinson's Disease (RESET) | ClinicalTrials.gov. The trial is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study designed to evaluate the JOTROL^™ in Parkinson's Disease. In a well-established model of Parkinson's Disease JOTROL^™ demonstrated statistically significant neuroprotective effects including rotarod performance and grip strength, indicating preservation of motor function. These data supported the IND granted to the Company in November 2025. A summary of key milestones and observations:

• Enrollment underway — Phase 2a RESET trial (NCT07592767) actively enrolling;
• FDA IND Cleared — November 2025, enabling commencement of Phase 2a clinical evaluation (administrative clearance only; does not imply approvability)
• ~9-fold higher overall plasma bioavailability vs. conventional resveratrol (Cmax 455 ng/mL vs. 85 ng/mL in Phase 1, n=24 healthy volunteers) https://clinicaltrials.gov/study/NCT04668274
• Measurable CSF drug levels observed in Phase 1, supporting CNS exposure

Moussa, C., et al. (2022). CNS bioavailability of JOTROL™. Journal of Alzheimer's Disease, 88(3), 1015–1028. https://doi.org/10.3233/JAD-220211

• No serious adverse events in completed Phase 1 study (n=24 healthy volunteers)
  
  

https://clinicaltrials.gov/study/NCT04668274

• 3 study centers — Georgetown University MedStar Hospital (DC), Montgomery and Franklin Square Hospitals (MD), MedStar McLean Clinic (VA)
  
  

The RESET trial design as referenced on clinicaltrials.gov is summarized here:

Parameter	Detail
Sponsor	Georgetown University / Jupiter Neurosciences / MedStar Health
Enrollment	30 patients (1:1:1 randomization: two doses vs. placebo)
Duration	12 weeks
Study Period	Enrollment underway; projected study completion H1 2027
Primary Endpoints	Safety, tolerability, pharmacokinetics (plasma & CSF)
Secondary Endpoints	ATP blood levels, inflammatory biomarkers (blood & CSF)
Eligibility	PD per UK Brain Bank criteria, H&Y Stage 2–3, age 55–85, MoCA ≥18, stable on levodopa/DA agonists ≥4 weeks

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 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, JOTROL^™ -- a proprietary, enhanced bioavailability resveratrol formulation -- is currently in a Phase IIa clinical trial for Parkinson's disease. JUNS also commercializes Nugevia^™, a consumer longevity supplement.

The Company has recently entered into a term sheet to acquire ALA-002 from PharmAla Biotech, a next-generation, patented psychedelic NCE. The closing of this transaction would further strengthen the Company's CNS pipeline by adding a next-generation, patented psychedelic NCE at a pivotal moment in U.S. regulatory policy. 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 patient enrolment and dosing timelines for the Phase 2a RESET trial; expected study completion dates; the proposed acquisition of exclusive U.S. licensing rights to ALA-002 from PharmAla Biotech Holdings Inc., which remains subject to due diligence, definitive agreements, regulatory approvals, and other customary closing conditions; 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 proposed ALA-002 transaction may not be consummated on the expected timeline 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. 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

Media Contact

Josh Birch, Media Relations Manager

KNB Communications

JBirch@KNBComm.com