EA Pharma announces phase 3 trial for new schizophrenia treatment in Japan

Esme Needham | January 7, 2026 | News story | Research and Development Psychiatry, ea pharma, schizophrenia 

EA Pharma, a subsidiary of Eisai, has announced the initiation of a phase 3 clinical trial of evenamide, a schizophrenia treatment, in Japan.

The trial will evaluate patients with treatment-resistant schizophrenia who have demonstrated poor or insufficient response to at least two antipsychotic treatments. It will study the efficacy, safety and tolerability of evenamide as an add-on to existing treatments for schizophrenia.

Schizophrenia is a psychological disorder characterised by symptoms including hallucinations, delusions, emotional difficulties and cognitive impairment. It is estimated to affect around 1% of the population of Japan. Many of the antipsychotics currently used to treat schizophrenia, which use the dopamine and/or serotonin pathways to achieve reduction in symptoms, have unwanted side effects. These side effects can include prolactin elevation and weight gain.

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In addition, many patients treated with antipsychotics for schizophrenia find that their condition becomes resistant or unresponsive to treatment. There is an unmet medical need for new treatments that can reduce side effects and tackle drug resistance.

Evenamide is an excessive glutamate release modulator. The phase 3 008A trial of evenamide met its key primary and secondary endpoints, and the drug showed statistically significant effects as an add-on treatment compared to placebo. Treatment with evenamide was associated with an increase in patients experiencing ‘clinically meaningful benefit’.

EA Pharma is a speciality pharmaceutical company, founded in 2016 through the combination of the gastrointestinal business units at Eisai and the Ajinomoto Group.

Stefan Weber, CEO of Newron Pharmaceuticals, a partner of EA Pharma, commented: “The initiation of EA Pharma’s phase 3 study of evenamide in Japan represents an important step in the global development of the programme.”

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