In short
Brexanolone caprilcerbate is an investigational chemical substance being studied as an oral capsule for adults with major depressive disorder (MDD), with or without anxious distress. Two Phase 2 trials are authorised in the EU Clinical Trials Information System: one placebo-controlled efficacy study with 367 participants and one open-label safety extension with 379 participants. The substance has no marketing authorisation in the product records and is supplied by Seaport Therapeutics, Inc.
Key points
- Brexanolone caprilcerbate is an investigational oral capsule, not yet an authorised medicine.
- It is being studied in Phase 2 trials for adults with major depressive disorder, with or without anxious distress.
- One trial is placebo-controlled and measures change in the HAM-D-17 depression score over 42 days.
- The other trial is an open-label extension focused on safety and tolerability over 6 weeks.
- Together, the two authorised trials plan to enrol 746 participants.
- The substance is given as a 375 mg oral capsule once daily in the studies.
What is brexanolone caprilcerbate?
Brexanolone caprilcerbate is a chemically synthesised substance classified in the therapeutic area of psychiatry and psychology, specifically mental disorders. It is an investigational substance with no marketing authorisation in the product records of the trials listed here. The substance is supplied by Seaport Therapeutics, Inc.
In the registry records, the substance is also referred to by the development code SPT-300.
How does brexanolone caprilcerbate work?
The registry records do not describe the mechanism of action of brexanolone caprilcerbate in detail. The substance is being studied for its effects on depressive symptoms, but the specific molecular target or pathway is not stated in the provided data. The trials measure changes in depression rating scales to assess whether the substance has an effect on mood symptoms.
Which conditions is it studied for?
- Major depressive disorder (MDD) — a mental health condition characterised by persistent low mood and loss of interest, which the trials aim to treat with brexanolone caprilcerbate.
- Major depressive disorder with anxious distress — a form of MDD accompanied by symptoms of anxiety, included in both trials as a permitted subtype.
How is brexanolone caprilcerbate given?
Brexanolone caprilcerbate is given as an oral capsule. In the trials, the dose studied is 375 mg taken orally. The pharmaceutical form is a capsule, and the route of administration is oral.
What do the clinical trials show?
Two Phase 2 trials of brexanolone caprilcerbate are authorised in the EU Clinical Trials Information System, both in adults with major depressive disorder, with or without anxious distress.
What are the trials measuring?
The placebo-controlled trial measures the change from baseline to day 42 in the Hamilton Depression Rating Scale-17 (HAM-D-17) total score, a standard tool for assessing the severity of depressive symptoms. The open-label extension study measures the incidence, severity, and duration of treatment-emergent adverse events and serious adverse events, as well as suicidal ideation and behaviour using the Columbia Suicide Severity Rating Scale.
Who can take part in these trials?
Both trials enrol adults with major depressive disorder, with or without anxious distress. The placebo-controlled study is randomised, parallel-group, and double-blind, meaning participants are assigned by chance to receive either brexanolone caprilcerbate or a placebo, and neither they nor the investigators know which one they receive. The extension study is open-label, meaning all participants receive the active substance.
What status are the trials in?
Both trials are listed as Authorised in the EU Clinical Trials Information System, meaning they have received regulatory approval to proceed but have not yet reported results on the registry.
What side effects are known?
No side effect data from supplementary sources are available in the provided information. The safety profile of brexanolone caprilcerbate is being assessed in the ongoing trials, which specifically measure treatment-emergent adverse events, serious adverse events, and changes in vital signs, electrocardiograms, safety laboratory values, and physical examination findings.