Ulotaront enters phase 2/3 clinical trial for MDD treatment efficacy

Two pharmaceutical firms announced they have started a phase 2/3 trial to evaluate the efficacy of ulotaront, a trace amine-associated receptor 1 agonist, as an adjunctive therapy for major depressive disorder treatment, according to a joint press release.

Ulotaront is the first trace amine-associated receptor 1 (TAAR1) agonist to enter phase 2/3 trials as an adjunctive therapy for major depressive disorder (MDD), and the first TAAR1 agonist to enter phase 3 trials for schizophrenia in adults and adolescents, according to the release from Otsuka and Sunovion. The therapy is being jointly developed and commercialized by the two companies.

“MDD is a disabling mental health condition that often requires a combination of first-line antidepressant medication and adjunctive treatments to alleviate symptoms,” John Kraus MD PhD, Otsuka executive vice president and chief medical officer, said in the release. “Even with available approaches, many patients do not achieve optimal responses to treatment, in part due to the heterogeneous nature of the condition, highlighting the need for new and different treatment modalities.”

The global, multicenter, randomized, double-blind, placebo-controlled phase 2/3 trial will examine ulotaront’s efficacy in reducing depressive symptoms in patients with MDD.

“The initiation of the phase 2/3 study evaluating the use of ulotaront as an adjunctive treatment of major depressive disorder is an important step toward exploring the full medical potential of this novel TAAR1 agonist,” Armin SzegediMDPhD, Sunovion senior vice president and chief medical officer, said in the release. “We have been encouraged by the pre-clinical data showing that ulotaront could have benefits for those living with mood disorder and look forward to enhancing the understanding of this innovative compound in collaboration with Otsuka.”