First patient randomized in phase 2/3 trial of ulotaront for anxiety

Key takeaways:

• A randomized controlled trial of ulotaront for generalized anxiety disorder enrolled its first participant.
• The drug is also being tested for the treatment of schizophrenia and major depression.

The first participant has been randomized in a phase 2/3 clinical trial of ulotaront for the treatment of generalized anxiety, according to a press release from the manufacturers.

The manufacturers, Sunovion Pharmaceuticals and Otsuka Pharmaceutical Development & Commercialization, anticipate 434 patients with generalized anxiety disorder (GAD) will ultimately be randomized in the multicenter, double-blind, placebo-controlled study of ulotaront (SEP-363856). Participants will be assigned 1:1 to either ulotaront or placebo for 8 weeks. Ulotaront will be administered in dosages of 50 mg to 75 mg per day, according to the release.

The drug is also in late-stage clinical trials to assess its viability for treating major depressive disorder and schizophrenia.

“With the expansion of ulotaront’s clinical development program to a third indication, we are making significant progress towards goals we set for co-development and co-commercialization with Sunovion to address areas of high unmet need for people living with serious mental illnesses,” John Kraus, MD, PhD, executive vice president and chief medical 1A officer at Otsuka, said in the release. “We believe that ulotaront has the potential to help those living with GAD safely and effectively manage their symptoms and we look forward to advancing the understanding of this innovative compound.”