In short
SUL-238 is an investigational medicine being studied for early, untreated Parkinson's disease. It is a chemical substance given as a film-coated tablet by mouth. One Phase 2 trial is currently authorised to test its safety and efficacy in 45 participants.
Key points
- SUL-238 is an investigational substance with no marketing authorisation.
- It is being studied in a Phase 2 trial for early, untreated Parkinson's disease.
- The trial plans to enrol 45 participants.
- The main measure is the change in mitochondria-related brain metabolites after 4 weeks.
- SUL-238 is given as a film-coated tablet by mouth.
- The trial is currently authorised but not yet reporting results.
What is SUL-238?
SUL-238 is a chemically synthesised substance that is being developed as a potential medicine for Parkinson's disease. It is not yet an authorised medicine; the product records show no marketing authorisation, meaning it remains an investigational substance. The substance is supplied by GEN ILAC VE SAGLIK URUNLERI SANAYI VE TICARET A.S. and appears under the single product name SUL-238 in the trial records.
How does SUL-238 work?
The trial record describes SUL-238 as a drug intended to affect mitochondria-related brain metabolites in people with Parkinson's disease. The primary outcome measures changes in the concentration of three such metabolites — ATP, phosphocreatine and inorganic phosphate — in specific brain regions. These molecules are involved in how brain cells produce and store energy, and the trial aims to assess whether SUL-238 changes their levels compared with placebo.
Which conditions is SUL-238 studied for?
- Parkinson's disease — a progressive condition of the nervous system that affects movement. The trial focuses on people with early, untreated Parkinson's disease.
The therapeutic area of the trial is diseases of the nervous system.
How is SUL-238 given?
SUL-238 is given as a film-coated tablet by mouth. In the authorised trial, the dose under investigation is 4500 mg. The trial also includes a comparison arm with an identical tablet that does not contain the active substance, known as a placebo.
What do the clinical trials show?
One Phase 2 trial of SUL-238 is authorised in the EU Clinical Trials Information System. The trial is interventional and plans to enrol 45 participants with early, untreated Parkinson's disease. Its main purpose is to assess the safety and efficacy of SUL-238. The primary outcome is the mean change from baseline to week 4 in the concentration of mitochondria-related brain metabolites — ATP, phosphocreatine and inorganic phosphate — measured by ³¹P-Magnetic Resonance Spectroscopic imaging in three brain regions: the putamen, the substantia nigra and the motor cortex. Each active dose group is compared with placebo. The trial is currently authorised, and no results are reported in the registry.
What side effects are known?
The trial registry records do not yet list side effects for SUL-238. Because the trial is still in an early phase and no results have been reported, safety information is not available from these records.