Poster
107
(#107) Trial in Progress: Phase 3 Study of the Efficacy and Safety of Ulotaront in Acutely Psychotic Participants With Schizophrenia
Psych Congress 2025
Abstract: Introduction: Ulotaront is a trace amine-associated receptor 1 agonist (TAAR1) with 5-HT1A agonist activity under investigation for treatment of schizophrenia, major depressive disorder, and generalized anxiety disorder. Notably, ulotaront shows no dopamine D2 receptor blockade, representing a potentially novel mechanism of action for schizophrenia treatment. The efficacy and tolerable safety profile of ulotaront was demonstrated in Phase 2 trials. Currently, ulotaront is being evaluated in a Phase 3 trial actively recruiting acutely psychotic participants with schizophrenia.
Methods: This multicenter, randomized, double-blind, parallel-group, placebo-controlled trial (NCT06894212) is evaluating the efficacy, safety, and tolerability of ulotaront in acutely psychotic participants with schizophrenia in the US and Japan. Eligible participants include adults (18-65 years) with schizophrenia experiencing an acute exacerbation of psychotic symptoms (onset ≤2 months before screening) who have demonstrated responsiveness to previous antipsychotics in the last 12 months. This study consists of 3 periods: inpatient screening (≤14 days), double-blind treatment (6-weeks), and follow-up (~7 days post-last dose). Approximately 522 participants will be randomly assigned (1:1:1) to 3 treatment arms: 75 mg/day ulotaront, 100 mg/day ulotaront, or placebo. Primary endpoint is change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total score; secondary endpoint is change from baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) score. Safety endpoints include incidence of adverse events (AEs) and serious AEs, including any leading to discontinuation.
Results: US study enrollment is ongoing.
Conclusion: Ulotaront is being further evaluated for efficacy, safety, and tolerability in acutely psychotic participants with schizophrenia.
Short Description: Ulotaront, a TAAR1 agonist with no dopamine D2 receptor blockade, is under investigation for schizophrenia and other psychiatric conditions. This ongoing Phase 3, 6-week, double-blind, placebo-controlled trial (NCT06894212) is actively enrolling acutely psychotic participants in the US. Participants will be randomly assigned to receive 75 mg/day ulotaront, 100 mg/day ulotaront, or placebo. Efficacy and safety measures include change from baseline to Week 6 in PANSS total score and CGI-S score, adverse event incidence, and discontinuations.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc
Methods: This multicenter, randomized, double-blind, parallel-group, placebo-controlled trial (NCT06894212) is evaluating the efficacy, safety, and tolerability of ulotaront in acutely psychotic participants with schizophrenia in the US and Japan. Eligible participants include adults (18-65 years) with schizophrenia experiencing an acute exacerbation of psychotic symptoms (onset ≤2 months before screening) who have demonstrated responsiveness to previous antipsychotics in the last 12 months. This study consists of 3 periods: inpatient screening (≤14 days), double-blind treatment (6-weeks), and follow-up (~7 days post-last dose). Approximately 522 participants will be randomly assigned (1:1:1) to 3 treatment arms: 75 mg/day ulotaront, 100 mg/day ulotaront, or placebo. Primary endpoint is change from baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) total score; secondary endpoint is change from baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) score. Safety endpoints include incidence of adverse events (AEs) and serious AEs, including any leading to discontinuation.
Results: US study enrollment is ongoing.
Conclusion: Ulotaront is being further evaluated for efficacy, safety, and tolerability in acutely psychotic participants with schizophrenia.
Short Description: Ulotaront, a TAAR1 agonist with no dopamine D2 receptor blockade, is under investigation for schizophrenia and other psychiatric conditions. This ongoing Phase 3, 6-week, double-blind, placebo-controlled trial (NCT06894212) is actively enrolling acutely psychotic participants in the US. Participants will be randomly assigned to receive 75 mg/day ulotaront, 100 mg/day ulotaront, or placebo. Efficacy and safety measures include change from baseline to Week 6 in PANSS total score and CGI-S score, adverse event incidence, and discontinuations.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc
