In short
Evenamide is an investigational chemical substance being studied as an add-on treatment for treatment-resistant schizophrenia (TRS). It is given by mouth as capsules and is not yet authorised as a medicine. The only registered trial is a Phase 3 study in 612 patients comparing evenamide 15 mg and 30 mg twice daily with placebo over 12 weeks. Supplementary sources describe earlier Phase 2/3 research in people who responded poorly to antipsychotics.
Key points
- Evenamide is a glutamate modulator developed as an add-on treatment for schizophrenia.
- The registered trial is a Phase 3 study in treatment-resistant schizophrenia (TRS).
- The trial enrolled 612 participants and is currently authorised.
- Evenamide is given as capsules by oral use, at 15 mg or 30 mg twice daily.
- The main measure is the change in the PANSS total score from baseline to week 12.
- Evenamide has no marketing authorisation in the product records and remains investigational.
What is evenamide?
Evenamide is a chemically synthesised substance being developed as an add-on treatment for schizophrenia. It is classified in the therapeutic area of psychiatry and psychology, specifically mental disorders. The product records list Newron Pharmaceuticals SpA as the authorisation holder and supplier. Evenamide has no marketing authorisation in these records, which means it is an investigational substance still under study.
How does evenamide work?
Evenamide is described in the scientific literature as a glutamate modulator. Glutamate is a chemical messenger in the brain. Most available antipsychotics act on monoaminergic systems, but these systems are not always disrupted in schizophrenia. Evenamide is being studied because it targets a different pathway, the glutamate system, which may offer a new approach for people who do not respond adequately to existing antipsychotics.
Which conditions is evenamide studied for?
- Treatment-resistant schizophrenia (TRS) — a form of schizophrenia in which symptoms continue despite treatment with antipsychotic medicines. The Phase 3 trial studies evenamide in people with TRS who are not responding to their current antipsychotic.
- Chronic schizophrenia with inadequate response — an earlier Phase 2/3 study tested evenamide in people with chronic schizophrenia who were still symptomatic while taking a second-generation antipsychotic.
How is evenamide given?
Evenamide is given by mouth as capsules. In the Phase 3 trial, the doses studied are 15 mg twice daily and 30 mg twice daily, compared with placebo. The earlier Phase 2/3 study used a dose of 30 mg twice daily added to a stable dose of a second-generation antipsychotic.
What do the clinical trials show?
The registered trial is a Phase 3, interventional study in 612 participants with treatment-resistant schizophrenia. It compares evenamide 15 mg twice daily and 30 mg twice daily with placebo over 12 weeks, while participants continue their current antipsychotic medication. The main outcome is the mean change from baseline to week 12 on the PANSS total score, a scale that measures positive, negative and general symptoms of schizophrenia. Safety is assessed through treatment-emergent adverse events, adverse events leading to discontinuation and serious adverse events.
An earlier Phase 2/3 study enrolled 291 people with chronic schizophrenia who were inadequately responding to a second-generation antipsychotic. Participants received evenamide 30 mg twice daily or placebo for 4 weeks, added to their existing antipsychotic. The primary outcome was also the change in PANSS total score. The published report states that add-on treatment with evenamide was associated with a statistically significant improvement compared with placebo.
What side effects are known?
The Phase 3 trial collects information on treatment-emergent adverse events, adverse events leading to discontinuation and serious adverse events, but the registry record does not report specific side effect frequencies. The published Phase 2/3 report describes the trial as evaluating safety and tolerability, but the provided source text does not list individual side effects. No detailed side effect profile is available from the sources provided.