A Phase 3 interventional study of KarXT and KarXT Matching Placebo in Schizophrenia, sponsored by Bristol-Myers Squibb. Recruiting at 36 sites in 4 countries. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
Among 20 studies testing xanomeline in Schizophrenia — 9 open to participants now, 9 under way, 4 of them phase 3. xanomeline · Schizophrenia.
Among the 20 studies testing xanomeline in Schizophrenia, this one is the 13th largest by planned enrollment, is one of 5 that started in 2026, is one of 14 in phase 3, and was the 17th registered.
3,565 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
Browse Schizophrenia studies →9 of the 20 studies testing xanomeline in Schizophrenia are open now, in 12 countries. Recruiting first, the newest first:
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Sites in United States, Argentina, Bulgaria and 4 more countries
Ages 18–65
New York State Psychiatric Institute · Sites in United States
Ages 18–50
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Sites in United States, Australia, Canada and 8 more countries
Ages 5–17
Bristol-Myers Squibb · Sites in United States
Ages 18–65
Bristol-Myers Squibb · Sites in United States
Ages 18–55
By country, each count listing its studies:
xanomeline: first FDA approval 2024 (COBENFY). What it is approved for, and how studies give it, is on its page →
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 13 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 14 · Phase 4 3
First in 2018; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 166 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Median enrollment 178 across the 20 interventional studies. Of the 10 that completed or were terminated, 9 (90%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 20 have an industry lead sponsor. The 7 most frequent:
Bristol-Myers Squibb is the lead sponsor of 1,560 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
21 studies in Schizophrenia by Bristol-Myers Squibb: 8 open now, 9 under way, 4 of them phase 3. Of 12 finished, 9 (75%) have results posted.
Among the 21 studies in Schizophrenia by Bristol-Myers Squibb, this one is the 12th largest by planned enrollment of the 17 interventional ones that give a count, is one of 7 that started in 2026, is one of 13 in phase 3, and was the 16th registered.
Bristol-Myers Squibb’s Schizophrenia studies by the year they started, since 2016.
2 of the studies testing xanomeline in Schizophrenia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07423546New York State Psychiatric InstituteA PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia | 2027-04-30 |
| NCT07061288Bristol-Myers SquibbA Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT | 2027-06-21 |
Add all 2 to your calendar (.ics) → With an account.
Among the 20 studies testing xanomeline in Schizophrenia, from their registry updates:
Among Bristol-Myers Squibb’s 21 in Schizophrenia:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: KarXT
Other: KarXT Matching Placebo
Drug pages: Xanomeline · Trospium
Specified dose on specified days
Also known as: BMS-986510
Specified dose on specified days
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Week 5
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
Time frame: Week 5
Change From Baseline in PANSS Positive Subscale Score
Time frame: Week 5
Change From Baseline in PANSS Negative Subscale Score
Time frame: Week 5
Change From Baseline in PANSS Marder Negative Factor Score
Time frame: Week 5
Number of Participants With PANSS Response
PANSS response will be determined by ≥ 30% reduction in PANSS total score.
Time frame: Week 5
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Week 5
Change From Baseline in Children's Global Assessment Scale (CGAS)) Score
Time frame: Week 5
Not enrolling at this site — choose another above.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Jan 2026 (actual). Primary completion is estimated for Dec 2029, 46 months after the start.
Of 99 industry-sponsored phase 3 interventional studies under Schizophrenia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 41. This study's planned 46 months is above that.
Counting every sponsor, half of 113 studies reached it within 32 months; a quarter within 20 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Xanomeline · Trospium