trial

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

NCTId NCT07424404
as of 2026-07-01
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at a glance
Phase 3 · Recruiting
Enrollment 400 (estimated)
Sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Primary completion 2030-03-08
Synthesized from structured facts only — each point cited above.

Design & status

Phase
Phase 3
Status
Recruiting
Enrollment
400 (estimated)
Study type
Interventional
Allocation
Non Randomized
Model
Single Group
Masking
None
Start
2026-04-07
Primary completion
2030-03-08
Eligibility
ALL · 5 Years · 17 Years

Interventions & indications

Drugs
Xanomeline-trospium (Cobenfy)

Sponsors

Karuna Therapeutics, Inc., a Bristol Myers Squibb companyLead Sponsor

Sites

58 total
Anaheim, United StatesChino, United StatesCulver City, United StatesRedlands, United StatesSan Francisco, United StatesOrlando, United StatesAtlanta, United StatesLawrenceville, United StatesStone Mountain, United StatesChicago, United StatesBoston, United StatesWorcester, United States

Linked catalysts

1
A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC f — primary completion2030-03-08

Facts & assertions

4 sourced
Enrollment
400
Phase
PHASE3
Primary Completion Date
2030-03-08
Status
RECRUITING
relationships
The graph out of here
drug
Xanomeline-trospium (Cobenfy)
drug
lead_sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
company
indication
Schizophrenia
indication
Schizophrenia
indication
Autism-Related Irritability
indication