NCT07786454

Brief Summary

This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,120

participants targeted

Target at P75+ for phase_3

Timeline
32mo left

Started Oct 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 6, 2026

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2029

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2029

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

2.6 years

First QC Date

August 20, 2026

Last Update Submit

August 20, 2026

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety DisorderGADAnxiety

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation

    Throughout the trial (up to Week 27)

Secondary Outcomes (2)

  • Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score

    Baseline, Weeks 8, 14, and 26

  • Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score

    Baseline, Weeks 8, 14, and 26

Other Outcomes (8)

  • Percentage of Participants With Any Change in Laboratory Tests Values From Baseline

    Baseline, Weeks 8, 20, and 26

  • Percentage of Participants With Any Change in Potentially Clinically Relevant Vital Signs From Baseline

    From Baseline up to Week 26

  • Percentage of Participants With Any Change From Baseline in Weight, Body Mass Index (BMI) and Waist Circumference

    Baseline, Weeks 8 and 26

  • +5 more other outcomes

Study Arms (1)

SEP-363856

EXPERIMENTAL

Participants will receive SEP-363856 50 mg or 75 mg tablet, orally, once daily for up to 26 weeks.

Drug: SEP-363856

Interventions

SEP-363856DRUG

Oral tablet

Also known as: Ulotaront
SEP-363856

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participants at least 18 years of age at the time of informed consent
  • Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention
  • Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856
  • Participant is willing and able to comply with study procedures and visit schedule
  • 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

You may not qualify if:

  • Diagnosis other than GAD that is the primary focus of treatment
  • Clinically significant psychiatric or medical condition that may interfere with study participation
  • 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
  • Clinically significant abnormal laboratory values or ECG findings
  • Significant suicide risk
  • Substance use/positive drug screen
  • Use of prohibited medications/therapies
  • Known sensitivity to SEP-363856

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Otsuka Call Center

CONTACT

844-687-8522ProfessionalServices@otsuka-us.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 26, 2026

Study Start (Estimated)

October 6, 2026

Primary Completion (Estimated)

May 26, 2029

Study Completion (Estimated)

June 2, 2029

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access Criteria
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
More information