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New anxiety drug shows promise in clinical trial

NCT ID NCT05729373

Symptom relief 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medication called SEP-363856 in 434 adults with generalized anxiety disorder. Participants took either the drug or a placebo for up to 12 weeks. Researchers measured changes in anxiety symptoms using standard rating scales to see if the drug was safe and effective.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

434 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2025

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 to 65 years

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.

Inclusion Criteria: (list is not all inclusive) * Male or female subject between 18 to 65 years of age. * Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder. * Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions. Exclusion Criteria: (list is not all inclusive) * Subject has DSM-5-based diagnosis of any disorder other than Generalized Anxiety Disorder that was the primary focus of treatment within 12 months before Screening. * Subjects who report an inadequate response to more than 3 antidepressant treatments * Subject is at significant risk of harming self or others based on Investigator's judgment. * Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study. * Female subject who is pregnant, lactating, or plans to get pregnant during the study.

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Conditions

The condition(s) this trial relates to.

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

  • Aava Laakarikeskus - Aava Kamppi

    Helsinki, 00100, Finland

  • Adams Clinical

    Watertown, Massachusetts, 02472, United States

  • Advanced Discovery Research LLC

    Atlanta, Georgia, 30318, United States

  • Akari Clinic

    Naha, Okinawa, 900-0004, Japan

  • American Medical Research, Inc.

    Warrenville, Illinois, 60555, United States

  • Anderson Clinical Research

    Redlands, California, 92374, United States

  • BONA MEDIC, s.r.o.

    Zlaté Moravce, 95301, Slovakia

  • Barclay Imuro Mental Clinic

    Urasoe-shi, Okinawa, 901-2104, Japan

  • Berman Clinical

    New York, New York, 10029, United States

  • Bioscience Research, LLC

    Mount Kisco, New York, 10016, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CNS Healthcare

    Jacksonville, Florida, 32256, United States

  • California Neuroscience Research, LLC

    Sherman, California, 91403, United States

  • Cedar Clinical Research, Inc.

    Draper, Utah, 84020, United States

  • CenExel Collaborative Neuroscience Research

    Torrance, California, 90502, United States

  • CenExel Hassman Research Institute

    Marlton, New Jersey, 08053, United States

  • CenExel iResearch Atlanta

    Atlanta, Georgia, 30030, United States

  • CenExel iResearch Savannah

    Savannah, Georgia, 31405, United States

  • Center for Emotional Fitness Site

    Cherry Hill, New Jersey, 08002, United States

  • Combined Research Orlando

    Orlando, Florida, 32803, United States

  • Copley Clinical

    Boston, Massachusetts, 02116, United States

  • Crystal Comfort s.r.o.

    Vranov nad Topľou, 9301, Slovakia

  • DCC "Mladost M" - Varna, OOD Site #156

    Varna, 9020, Bulgaria

  • DCC "Mladost M" - Varna, OOD Site #157

    Varna, 9020, Bulgaria

  • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD

    Sofia, 1408, Bulgaria

  • Epamed sro

    Košice, 040 01, Slovakia

  • Excell Research, Inc.

    Oceanside, California, 92056, United States

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231, United States

  • Hayakawa Clinic

    Kure-shi, Hiroshima, 737-0111, Japan

  • Higashi-Sapporo Mental Clinic

    Sapporo, Hokkaido, 003-0003, Japan

  • Hiro Mental Clinic

    Fukuoka, Fukuoka, 810-0004, Japan

  • Hirota Clinic

    Kurume-shi, Fukuoka, 830-0033, Japan

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922, Spain

  • Hospital Universitario Infanta Leonor

    Madrid, 28031, Spain

  • Hospital Valle del Nalon

    Langreo, Principality of Asturias, 33920, Spain

  • Hospital de Antequera

    Málaga, 29200, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025, Spain

  • IMA Clinical Research Phoenix

    Phoenix, Arizona, 85012, United States

  • Institucion Hospitalaria Hestia Palau

    Barcelona, 8025, Spain

  • K2 Medical Research, LLC

    Tampa, Florida, 33607, United States

  • Kokura Mental Clinic

    Kitakyushu-shi, Fukuoka, 802-0006, Japan

  • Lehigh Center for Clinical Research, LLC

    Allentown, Pennsylvania, 18104, United States

  • MENTUM, s.r.o.

    Bratislava, 82007, Slovakia

  • MHC - Sofia, EOOD

    Sofia, 1000, Bulgaria

  • Manhattan Behavioral Medicine

    New York, New York, 10036, United States

  • Marienthali Kliinik

    Tallinn, 11315, Estonia

  • Mederon Oy

    Helsinki, 00100, Finland

  • Medical Center "Sv.Naum"

    Sofia, 1113, Bulgaria

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center Intermedica, OOD

    Sofia, 1680, Bulgaria

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800, Bulgaria

  • Medical Center Mentalcare OOD

    Sofia, Plovdiv, 4004, Bulgaria

  • Mental Clinic Sakurazaka

    Fukuoka, Fukuoka, 810-0023, Japan

  • Midwest Research Group

    Saint Charles, Missouri, 63304, United States

  • Neuro-Behavioral Clinical Research, Inc.

    North Canton, Ohio, 44720, United States

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30328, United States

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516, United States

  • Oulu Mentalcare Oy

    Oulu, 90100, Finland

  • Pacific Clinical Research Management Group

    Upland, California, 91786, United States

  • Paradigm Research Professionals, LLP

    Oklahoma City, Oklahoma, 73116, United States

  • PharmaSite AB Malmö

    Malmö, 21152, Sweden

  • ProScience Research Group

    Culver City, California, 90230, United States

  • ProbarE- Lund

    Lund, 22222, Sweden

  • ProbarE- Stockholm

    Stockholm, 113 29, Sweden

  • Psychiatry and Psychotherapy Partners Austin

    Austin, Texas, 78737, United States

  • PsychoLine s.r.o.

    Rimavská Sobota, 97901, Slovakia

  • Sahlgrenska Universitetssjukhuset - Östra sjukhuset

    Gothenburg, 416 50, Sweden

  • Sangenjaya Nakamura Mental Clinic

    Setagaya-ku, Tokyo-To, 154-0004, Japan

  • Sangenjaya Neurology- Psychosomatic Clinic

    Setagaya-ku, Tokyo-To, 154-0004, Japan

  • Satakunnan Psykiatripalvelu

    Tampere, 33210, Finland

  • Savon Psykiatripalvelu Oy

    Kuopio, Northern Savonia, 70110, Finland

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403, United States

  • Senzoku Psychosomatic Medicine Clinic

    Meguro-ku, Tokyo-To, 152-0012, Japan

  • Shimode Mental Clinic

    Sapporo, Hokkaido, 062-0922, Japan

  • Shinseikai Kaku Mental Clinic

    Fukuoka, Fukuoka, 810-0022, Japan

  • Social Psychiatry Research Institute

    Brooklyn, New York, 11235, United States

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112, United States

  • Tartu University Hospital

    Tartu, 50417, Estonia

  • The Medical Research Network, L.L.C

    New York, New York, 10128, United States

  • Uematsu Mental Clinic

    Chikugo-shi, Fukuoka, 833-0041, Japan

  • University of Alabama at Birmingham

    Huntsville, Alabama, 35801, United States

  • Uptown Research Institute, LLC

    Chicago, Illinois, 60640, United States

  • Viking Pharmaceutical Trials Inc. dba Viking Clinical Research

    Temecula, California, 92591, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.