Jotrol, an oral formulation of the natural compound resveratrol, has been cleared for testing in people with Parkinson’s disease by the U.S. Food and Drug Administration (FDA).
Jupiter Neurosciences will conduct the Phase 2a clinical trial with Zina Biopharmaceuticals to evaluate the safety, tolerability, and pharmacological properties of the treatment, which is designed to harness the anti-inflammatory and antioxidant benefits of resveratrol in a capsule. Enrollment is expected to begin in early 2026.
“This … clearance from the FDA is an important step forward for Jupiter and the Parkinson’s community,” Christer Rosén, Jupiter’s chairman and CEO, said in a company press release. “We are proud to advance this innovative program and are now one step closer to initiating patient dosing.”
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Understanding Parkinson’s and resveratrol’s potential
Parkinson’s disease is caused by the dysfunction and death of dopaminergic neurons, or the nerve cells that produce dopamine, a signaling molecule that nerve cells use to communicate. The loss of dopamine signaling leads to disease symptoms, including movement and cognitive issues.
Although the exact trigger for the loss of dopaminergic neurons is not fully understood, neuroinflammation and oxidative stress, a type of cellular damage, are known to be involved. Resveratrol is a naturally occurring compound found in certain plants, such as red grapes, that possesses anti-inflammatory and antioxidant properties, which can help lower inflammation and oxidative stress.
Despite its potential to treat Parkinson’s, when taken orally at high doses, resveratrol may lead to digestive side effects. Jotrol is a new formulation where the compound is contained in a micellar structure, meaning it is dissolved as a soft gel that can be easily consumed as an oral capsule.
Additionally, Jotrol can cross the blood-brain barrier, a tight layer of cells lining the brain’s blood vessels, that prevents certain molecules, including medications, from entering the brain. This means the treatment can reach the brain and has the potential to treat neurological diseases.
According to the company, preclinical studies have demonstrated that Jotrol can improve motor function in a mouse model of Parkinson’s. Particularly, Jotrol was found to have a nine times higher bioavailability, or the ability of a substance to be absorbed and used by the body, than traditional resveratrol oral formulations.
Results from a Phase 1 trial (NCT04668274) have shown that Jotrol can deliver a therapeutically effective dose without the gastrointestinal side effects that have limited resveratrol’s therapeutic use.
“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,” Rosén said.