A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study ID
NCT07786454
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SEP-363856 — DRUG
    Oral tablet

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Oct 6, 2026
Status verified
Aug 2026
Primary completion
May 26, 2029
Completion
Jun 2, 2029

Study Design

Enrollment
1,120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation [ Time Frame: Throughout the trial (up to Week 27) ]

Central Contacts

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