A Phase 1 interventional study of KarXT in Schizophrenia, sponsored by Bristol-Myers Squibb. Recruiting at 8 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Bristol-Myers Squibb · Phase 1, 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 15th largest by planned enrollment, is one of 4 that started in 2025, is the only one in phase 1, and was the 14th registered.
3,565 studies on the registry are indexed under Schizophrenia; 492 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, Colombia, Japan and 1 more country
Ages 13–17
Bristol-Myers Squibb · Sites in United States
Ages 18–65
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 332 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 258 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 55 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. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 131 is above the median of 71 across 2,945 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 14th largest by planned enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2025, is one of 2 in phase 1, and was the 13th 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.
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Drug: KarXT
Drug pages: Xanomeline · Trospium
Specified dose on specified days
Also known as: BMS-986510
Number of participants with adverse events (AEs)
Time frame: Up to 3 weeks
Number of participants with adverse events of special interest (AESIs)
Time frame: Up to 3 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 3 weeks
Maximum concentration (Cmax)
Time frame: Up to 15 weeks
Time to maximum concentration (Tmax)
Time frame: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to infinity (AUC(INF))
Time frame: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to 672 hours (AUC(0-672))
Time frame: Up to 15 weeks
Apparent terminal phase half-life (T-HALF)
Time frame: Up to 15 weeks
Apparent total body clearance (CLT/F)
Time frame: Up to 15 weeks
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to 15 weeks
Number of participants with AEs
Time frame: Up to 3 weeks
Number of participants with AESIs
Time frame: Up to 3 weeks
Number of participants with SAEs
Time frame: Up to 3 weeks
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 Sep 2025 (actual). Primary completion is estimated for Jun 2027, 21 months after the start.
Of 108 industry-sponsored phase 1 interventional studies under Schizophrenia, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 21 months is above that.
Counting every sponsor, half of 133 studies reached it within 12 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
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.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Xanomeline · Trospium