Ulotaront Effective for Negative Symptoms in Patients With Acute Schizophrenia

The following article is a part of conference coverage from Psych Congress 2021 , held October 29th through November 1, 2021, in San Antonio, Texas. The team at Psychiatry Advisor will be reporting on the latest news and research conducted by leading experts in psychiatry. Check back for more from the Psych Congress 2021.


Ulotaront was found to be effective at treating negative symptoms of schizophrenia, according to the results of an initial double-blind study presented at Psych Congress 2021, held from October 29 to November 1, in San Antonio, Texas.

Ulotaront, an agonist at the trace amine-associated receptor 1 (TAAR1) and 5-hydroxytryptamine type 1A (5-HT1A) receptors, received breakthrough therapy designation from the US Food and Drug Administration. The agonist does not bind to D2 or 5-HT2A.

Researchers conducted a double-blind study and a 6-month open-label extension study to analyze the effects of ulotaront in patients with acute schizophrenia.

For 4 weeks, patients were randomly assigned to receive either ulotaront (50 or 75 mg; n=120) or placebo (n=125). Ulotaront was found to result in significantly greater improvement in negative symptoms on the Brief Negative Symptom Scale (BNSS) total score (ES 0.48) and factor scores, the MARDER Positive and Negative Syndrome Scale (PANSS) negative symptom factor (ES 0.46), and the Uncorrelated PANSS Score Matrix negative deficit of expression (UPSM-NDE, ES 0.32) and Uncorrelated PANSS Score Matrix negative-apathy/avolition (UPSM-NAA ES 0.32) factors.

In the extension study, patients who completed the double-blind study received flexible doses (25, 50, or 75 mg/d) of the drug. Ulotaront was found to be associated with mean improvement from baseline to last observation carried forward (LOCF) endpoint on the BNSS total score (-8.0), the PANSS negative subscale score (-3.5), the Marder PANSS negative symptom factor (-3.5), and the UPSM-NDE (-0.3) and UPSM-NAA (-0.3) factors.

Disclosure: This research was supported by Sunovion Pharmaceuticals Inc. Please see the original reference for a full list of disclosures.


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Dworak H, Hopkins S, Hayes R, et al. Effects of ulotaront (a TAAR1 agonist) on negative symptoms in schizophrenia: results from an initial double-blind acute study and a 6-month, open-label extension study. Presented at: Psych Congress 2021; October 29-November 1, 2021; San Antonio, Texas. Poster 135.