In short
MRM-3379 is an investigational substance being studied in male participants with Fragile X syndrome (FXS). One clinical trial is currently authorised: a Phase 2 study with 69 participants evaluating the safety and tolerability of MRM-3379 taken by mouth. The trial also includes a placebo comparison arm.
Key points
- MRM-3379 is an investigational substance with no marketing authorisation described in the available registry data.
- The only registered trial is a Phase 2 study in Fragile X syndrome.
- The trial plans to enrol 69 male participants.
- The study is currently authorised, meaning it has received regulatory approval to proceed.
- MRM-3379 is given by mouth (oral use).
- The main goal is to evaluate safety and tolerability, including treatment-emergent adverse events (TEAEs).
What is MRM-3379?
MRM-3379 is an investigational substance. The registry data provided does not state its chemical class, its mechanism of action, or any trade name. It is not described as an authorised medicine in these records. The substance is being studied in the context of Fragile X syndrome, a genetic condition that causes intellectual disability and behavioural challenges.
How does MRM-3379 work?
The available registry record does not describe the mechanism of action of MRM-3379. No molecular target, pathway, or pharmacological effect is stated in the trial data. For this reason, this section cannot provide details on how the substance is thought to work in the body.
Which conditions is MRM-3379 studied for?
The registered trial studies MRM-3379 in one condition:
- Fragile X syndrome (FXS): a genetic condition that is a leading inherited cause of intellectual disability and autism spectrum disorder features. The trial focuses on male participants with FXS.
How is MRM-3379 given?
MRM-3379 is given by mouth (oral use). The registry lists the pharmaceutical form as oral, but the exact dose is reported as 0 mg, meaning the dose was not reported in the register. The trial also includes a placebo for MRM-3379 as a comparison arm.
What do the clinical trials show?
One clinical trial of MRM-3379 is registered. It is a Phase 2, interventional study in male participants with Fragile X syndrome. The trial is authorised, meaning it has received regulatory approval but results are not yet reported in the registry. The planned enrolment is 69 participants.
The primary outcome is safety and tolerability. The trial measures the incidence and severity of treatment-emergent adverse events (TEAEs), which are side effects that appear or worsen after treatment starts. It also records withdrawal due to adverse events, meaning how many participants stop the study because of side effects.
What side effects are known?
The registry record does not list any known side effects for MRM-3379. Because the trial is still in an early phase and no results are reported, no safety information beyond the endpoints being measured is available. The study itself is designed to collect data on treatment-emergent adverse events and withdrawals due to adverse events.