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Can a new daily pill offer lasting relief for anxiety?

NCT ID NCT07786454

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial is testing the long-term safety and tolerability of an investigational drug called SEP-363856 (ulotaront) in adults with generalized anxiety disorder (GAD). Participants who completed a previous phase 3 study will take the drug daily for 26 weeks. The study will monitor side effects and also measure changes in anxiety symptoms using a standard rating scale. The goal is to see if this medication remains safe and effective over a longer period.

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 trial could support SEP-363856 as a long-term treatment option for generalized anxiety disorder, potentially offering an alternative to current therapies.
What could go wrong
This is an open-label extension study, meaning all participants know they are taking the drug, which can bias results. Long-term safety and efficacy are still being evaluated, and the drug may not prove more effective than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria 1. Male or female participants at least 18 years of age at the time of informed consent 2. Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention 3. Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856 4. Participant is willing and able to comply with study procedures and visit schedule 5. i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions Key Exclusion Criteria 1. Diagnosis other than GAD that is the primary focus of treatment 2. Clinically significant psychiatric or medical condition that may interfere with study participation 3. Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes 4. Clinically significant abnormal laboratory values or ECG findings 5. Significant suicide risk 6. Substance use/positive drug screen 7. Use of prohibited medications/therapies 8. Known sensitivity to SEP-363856

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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