In short
IRL757 is an investigational chemical substance developed by Integrative Research Laboratories Sweden AB (IRLAB). It is being studied as a potential treatment for apathy — a lack of interest or motivation — in adults with Parkinson's disease. One registered Phase 1 trial is currently authorised, planning to enrol 125 participants to test the safety and tolerability of two oral doses (10 mg and 30 mg) over 12 weeks.
Key points
- IRL757 is an investigational substance with no marketing authorisation in the product records.
- It is being tested in a Phase 1 trial in adults with Parkinson's disease and apathy.
- The trial plans to enrol 125 participants and is currently authorised.
- Two oral doses are studied: 10 mg and 30 mg capsules, compared with placebo.
- The main goal is to measure safety and tolerability over 12 weeks of daily dosing.
- The developer is Integrative Research Laboratories Sweden AB (IRLAB).
What is IRL757?
IRL757 is a chemically synthesised substance, classified in product records under nervous system diseases. It is being developed by Integrative Research Laboratories Sweden AB (IRLAB). The substance has no marketing authorisation in the product records, meaning it is still an investigational medicine and has not been approved for routine use. In the registered trial, IRL757 appears as the test substance in two trial records, indicating it is the active substance under investigation.
How does IRL757 work?
The registered trial records do not describe the mechanism of action of IRL757. The available data show only that the substance is given by mouth and is being tested in people with Parkinson's disease who have moderate to severe symptoms of apathy. No further details on its molecular target or how it acts in the body are provided in the source data.
Which conditions is it studied for?
- Parkinson's disease and apathy — the trial includes adults with Parkinson's disease who also have a lack of interest or motivation, described as moderate to severe apathy.
How is IRL757 given?
IRL757 is given as capsules taken by mouth (oral use). The registered trial tests two dose strengths: 10 mg and 30 mg capsules. The trial also includes placebo capsules as a comparison arm.
What do the clinical trials show?
One Phase 1 trial is registered for IRL757. It is currently authorised, meaning it has received regulatory approval to begin but may not yet be recruiting. The trial plans to enrol 125 participants with Parkinson's disease and apathy.
The study evaluates safety and tolerability of IRL757 after repeated daily dosing for 12 weeks. The primary outcome measures the frequency, seriousness, and severity of adverse events (side effects), as well as changes from baseline in physical examinations, clinical laboratory tests, vital signs, electrocardiograms (ECGs), the Columbia-Suicide Severity Rating Scale (C-SSRS), the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP-RS), and daytime sleepiness measured by the Epworth Sleepiness Scale (ESS).
Participants in the trial are adults with Parkinson's disease who have moderate to severe symptoms of apathy. The trial compares two doses of IRL757 (10 mg and 30 mg) with placebo capsules.
What side effects are known?
The registered trial records do not provide a list of known side effects for IRL757. Because the substance is still in Phase 1 testing, the trial itself is designed to collect information on safety and tolerability, including the frequency, seriousness, and severity of any adverse events that occur.