First patient dosed in Phase 2a oral therapy trial for Parkinson’s disease
RESET will assess safety, drug exposure, and biological markers over 12 weeks
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- Parkinson’s disease is characterized by the loss of dopamine-producing nerve cells, which contributes to movement difficulties and cognitive changes.
- The RESET Phase 2a trial is evaluating Jotrol, an oral resveratrol formulation with the potential to address pathways linked to Parkinson’s, including oxidative stress and mitochondrial dysfunction.
- Participants receive daily Jotrol or placebo to assess safety and pharmacokinetics and explore how the treatment may affect Parkinson’s symptoms.
The first patient has been dosed in a Phase 2a clinical trial evaluating Jotrol, an investigational oral formulation of resveratrol that Jupiter Neurosciences is developing for Parkinson’s disease. The trial is expected to be completed in the first half of 2029.
The RESET trial (NCT07592767) is enrolling up to 30 adults with Parkinson’s, ages 55 to 85, who are stable on standard treatments such as levodopa or dopamine agonists. The multicenter study is planned to involve about three sites in the U.S.
Oral therapy targets pathways linked to Parkinson’s
“Dosing the first patient in RESET is a significant milestone for Jupiter and the culmination of years of scientific, regulatory and clinical development work,” Christer Rosén, Jupiter’s CEO, said in a company press release. Rosén added, “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.”
Parkinson’s disease is marked by the progressive loss of nerve cells that produce dopamine, a brain chemical that nerve cells use to communicate. The resulting loss of dopamine signaling leads to the disease’s symptoms, including movement difficulties and cognitive changes.
Several processes are thought to contribute to nerve cell damage in Parkinson’s, including brain inflammation; oxidative stress, or damage caused by harmful molecules; and problems with mitochondria, the structures that produce energy for cells.
Jotrol is a micellar formulation of resveratrol, a natural compound found in plants such as grapes, that is delivered in an oral softgel capsule. It is designed to improve resveratrol’s bioavailability — how much of the compound reaches the body and can be used — and deliver a therapeutic dose without the digestive side effects associated with other resveratrol formulations.
Jotrol can also cross the blood-brain barrier and reach the central nervous system (CNS), which includes the brain and spinal cord.
“We believe that Jotrol has the potential to address biological pathways implicated in Parkinson’s disease, including mitochondrial dysfunction, oxidative stress and neuroinflammation,” Rosén said.
Earlier studies supported Phase 2 testing
In preclinical studies, Jotrol was shown to improve measures of motor function in a mouse model of Parkinson’s. In a Phase 1 trial (NCT04668274) involving healthy volunteers, Jotrol was generally well tolerated, with no serious adverse events reported. It also increased resveratrol bioavailability compared with conventional resveratrol formulations.
These findings supported moving Jotrol into Phase 2a testing in people with Parkinson’s. The U.S. Food and Drug Administration (FDA) cleared the study in 2025, and enrollment was underway by late May.
Participants will be randomly assigned to receive Jotrol at one of two target doses (200 or 400 mg), or a placebo, once daily for 12 weeks (about three months).
The trial’s main goals are to assess Jotrol’s safety, tolerability, and pharmacokinetics — how the body processes the treatment — including its levels in blood plasma and cerebrospinal fluid (CSF), the fluid surrounding the brain and spinal cord. Secondary measures include biomarkers related to inflammation, energy metabolism — the processes that convert nutrients into cellular energy — and Parkinson’s disease.
The study will also explore how Jotrol may affect motor and nonmotor Parkinson’s symptoms, cognitive and behavioral problems, and health-related quality of life.
“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 Fernando L. Pagan, MD, the study’s principal investigator and professor of neurology at Georgetown University School of Medicine. Georgetown University is the study’s sponsor. According to Pagan, the study may also help guide Jotrol’s future clinical development.
Alison Silva, Jupiter’s president and chief business officer, added, “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.”
The company also disclosed that Charbel Moussa, a Georgetown sub-investigator in the study, has financial interests related to Jupiter.
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