Roche Discontinues Phase II Clinical Trial of Ralmitaront for Schizophrenia Due to Lack of Efficacy

Recently, the U.S. ClinicalTrials.gov showed that Roche terminated the Phase II (NCT03669640) clinical trial of its schizophrenia candidate drug ralmitaront. This study aimed to evaluate the efficacy of ralmitaront compared to placebo in treating patients with negative symptoms of schizophrenia or schizoaffective disorder. The reason for the termination was that the interim analysis indicated ralmitaront was unlikely to meet the primary endpoint in this study.

This is also the second Phase II clinical trial to be terminated for this candidate drug. Last year, Roche also halted another Phase II study (NCT04512066) aimed at evaluating the efficacy of ralmitaront monotherapy in patients with an acute exacerbation of schizophrenia or schizoaffective disorder.

In Roche's latest Q1 2023 pipeline, the candidate drug was still listed, with an anticipated NDA submission in 2026 and beyond. However, upon inquiry, in the case where both of the aforementioned studies have been terminated, Roche has not yet initiated any new trials for this drug.

Ralmitaront is a trace amine-associated receptor 1 (TAAR1) agonist. After research, the most advanced progress targeting this point is Sunovion's (Sumitomo Pharma) ulotaront.

Ulotaront is a dual agonist of TAAR1 and serotonin 1A receptor (5-HT1A), which has previously received FDA Breakthrough Therapy designation. The drug is currently in Phase III trials for the treatment of schizophrenia, with clinical results expected to be announced this year.

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