Can a new pill quiet the mind? a large trial takes on anxiety

NCT ID NCT07767903

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

First seen Aug 17, 2026 · Last updated Aug 17, 2026

Summary

This trial is testing whether an experimental oral medication called SEP-363856 (ulotaront) can reduce anxiety symptoms in adults with generalized anxiety disorder (GAD). About 384 participants will receive either the drug or a placebo daily for 8 weeks. The main goal is to see if the drug improves anxiety scores compared to placebo, and to check its safety and tolerability.

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 daily medication option for people with generalized anxiety disorder, potentially offering better symptom control with fewer side effects than existing treatments.
What could go wrong: This is a phase 3 trial, but results are not guaranteed. The drug may not prove more effective than placebo, and side effects could emerge. It is also not a cure; it aims to manage symptoms while the medication is taken.

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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

Basil Clinical
RECRUITING

Jamaica, New York, 11413, United States
Lumina Clinical Research Center
RECRUITING

Cherry Hill, New Jersey, 08002, United States

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