GEN Pharmaceuticals has secured the BEBO Foundation approval for the ethical assessment of biomedical research to initiate a Phase II clinical trial in the Netherlands of its new drug, SUL-238, for mitochondrial dysfunction in patients with Parkinson's disease (PD).

The approval allows the company to activate its clinical site in Groningen, with patient enrolment scheduled to begin in April 2026.

The Phase II proof-of-concept study, SHEPHERD, is a randomised, double-blind, placebo-controlled, single-centre trial.

It will assess the effects of SUL-238 on high-energy phosphates using magnetic resonance spectroscopy (31P-MRS) in patients diagnosed with early-stage, untreated PD.

The primary aim of the study is to evaluate how SUL-238 works through MRS scans, which work similarly to magnetic resonance imaging (MRI) scans. The research will also examine the safety profile of SUL-238.

Researchers will evaluate whether SUL-238 enhances mitochondrial function in patients with PD by comparing it to a placebo.

Participants will take either SUL-238 or a placebo daily over a 28-day period. They will visit clinics every two weeks for routine check-ups and testing during treatment and again 28 days after their final dose.

Each participant will maintain a symptom diary and record their oral intake of SUL-238.

GEN Pharmaceuticals' chairman Abidin Gülmüş said: “Following the ethical approval, we look forward to starting patient enrolment in the Netherlands. This Phase II trial will be another key milestone toward addressing neurodegenerative diseases at its biological foundation.”

SUL-238 is a hibernation-inspired small molecule targeting mitochondria. The compound supports mitochondrial bioenergetics via complex I/IV activation and enhances mitochondrial function across various preclinical models of cardiovascular, renal, and neurodegenerative diseases.

GEN licenses SUL-238 from Sulfateq for applications in neurodegenerative diseases.