Can a new pill quiet the mind? a large trial puts it to the test

NCT ID NCT07759128

Recruiting now Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether an experimental oral medication called SEP-363856 (ulotaront) can reduce anxiety symptoms in adults with generalized anxiety disorder. Participants will receive one of two fixed doses of the drug or a placebo for 8 weeks. The main goal is to see if the drug leads to a greater improvement in anxiety scores compared to placebo, which could offer a new treatment option for this common condition.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: SEP-363856 (ulotaront), an oral tablet taken daily
What this could lead to: If successful, this could provide a new, non-addictive medication option for people with generalized anxiety disorder, potentially offering relief where current treatments fall short.
What could go wrong: This is an early-stage test in a large group, and the drug may not prove more effective than placebo. Possible side effects are not yet fully known, and results may not apply to all patients.

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Conditions

The condition(s) this trial relates to.

anxiety disorder generalized anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GENERALIZED ANXIETY DISORDER

Contacts and locations

Locations

Clinical Neuroscience Solutions, LLC
RECRUITING

Jacksonville, Florida, 32256, United States
FutureSearch Trials of Dallas
RECRUITING

Dallas, Texas, 75251, United States
Manhattan Behavioral Medicine PLLC
RECRUITING

New York, New York, 10036, United States

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