In short
NB-4746 is an investigational oral medicine being studied in people with amyotrophic lateral sclerosis (ALS). The available registry data describe one interventional trial, a Phase 1b/2 study that plans to enroll 80 participants to assess the safety of NB-4746 over 28 days and in longer-term treatment. The trial is currently authorised but not yet reporting results.
Key points
- NB-4746 is an investigational substance studied in amyotrophic lateral sclerosis (ALS).
- The trial is a Phase 1b/2 study with a planned enrollment of 80 participants.
- The study is currently authorised, meaning it has received approval but has not yet reported results.
- The primary focus is safety, including treatment-emergent adverse events and serious adverse events.
- NB-4746 is given orally, and the trial also includes riluzole and placebo as comparison arms.
What is NB-4746?
NB-4746 is an investigational substance that is being studied in people with amyotrophic lateral sclerosis (ALS). The available registry data do not describe its chemical class or mechanism of action. The substance is identified only by its development code, NB-4746, and no trade name or other name is listed in the trial record.
How does NB-4746 work?
The trial registry record does not describe the mechanism of action of NB-4746. No information is provided about its molecular target or how it might affect the course of ALS.
Which conditions is NB-4746 studied for?
- Amyotrophic lateral sclerosis (ALS) — a progressive neurological condition that affects nerve cells in the brain and spinal cord, leading to loss of muscle control.
How is NB-4746 given?
NB-4746 is given orally in the trial. The intervention list includes NB-4746 as an oral drug, alongside oral riluzole and placebo capsules for NB-4746.
What do the clinical trials show?
The registry contains one trial of NB-4746: a Phase 1b/2 study in participants with ALS. The trial is authorised and plans to enroll 80 participants.
The study has three parts. Phase 1b assesses the safety profile of NB-4746 over 28 days in participants with ALS. Phase 2 and an open-label extension assess the safety profile of NB-4746 in participants with ALS over a longer period.
The primary outcome measures are the number of treatment-emergent adverse events (TEAEs), the number of serious adverse events (SAEs), and changes in vital signs, clinical laboratory tests, and 12-lead electrocardiograms (ECGs).
The trial also includes riluzole, an approved medicine for ALS, and placebo capsules as comparison arms. Because the study is authorised but not yet completed, no efficacy results are available.
What side effects are known?
No side effect data for NB-4746 are available in the registry record. The trial is designed to measure side effects, including treatment-emergent adverse events and serious adverse events, but results have not yet been reported.