16+
Major trials tracked
Neuroscience · Live ClinicalTrials.gov data
Xanomeline-trospium (Cobenfy) clinical trial pipeline
The timeline below tracks the 16 largest phase 2–4 xanomeline-trospium trials on ClinicalTrials.gov by enrolment, 12 of them actively recruiting. The next phase 3 primary completion among them is expected Oct 2026. Refreshed daily — add up to four competitors to compare pipelines side by side.
16
Phase 3 trials
12
Actively recruiting
Oct 2026
Next phase 3 primary completion
7,055
Participants across trials
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Lead sponsor by trial count
xanomeline (16)13 active2021–2031
xanomeline
'21
'22
'23
'24
'25
'26
'27
'28
'29
'30
'31
xanomeline
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)P3
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)P3
ARISEP3
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of SchizophreniaP3
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)P3
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)P3
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)P3
BALSAM-1P3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)P3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)P3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)P3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)P3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or LamotrigineP3
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)P3
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)P3
Relapse Prevention Trial Evaluating KarXT Treatment in SchizophreniaP3
Upcoming readouts
12 ahead · xanomeline
Select a trial to load its full ClinicalTrials.gov record.
Key xanomeline-trospium trials
Top 12 of the 16 tracked phase 2–4 trials, ordered by phase and status. Each links to its full ClinicalTrials.gov record.
| Trial | Title | Phase | Status | Primary completion |
|---|---|---|---|---|
| NCT05304767 | An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequate… | Phase 3 | Recruiting | Mar 2026 |
| NCT05511363 | A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Dise… | Phase 3 | Recruiting | Oct 2026 |
| NCT06951698 | BALSAM-1 — A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder | Phase 3 | Recruiting | Nov 2026 |
| NCT06951711 | A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder… | Phase 3 | Recruiting | Nov 2026 |
| NCT06126224 | A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Dise… | Phase 3 | Recruiting | Dec 2026 |
| NCT07140913 | A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mi… | Phase 3 | Recruiting | Jun 2027 |
| NCT05980949 | Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis… | Phase 3 | Recruiting | Sept 2027 |
| NCT06947941 | A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzhei… | Phase 3 | Recruiting | Feb 2028 |
| NCT06929273 | A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BAL… | Phase 3 | Recruiting | Jun 2028 |
| NCT07011745 | A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associat… | Phase 3 | Recruiting | Nov 2028 |
| NCT07011732 | A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associat… | Phase 3 | Recruiting | Nov 2028 |
| NCT06937229 | A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease … | Phase 3 | Recruiting | Jun 2029 |
Related drug pipelines
FAQ
- How many clinical trials are running for xanomeline-trospium?
- ClinicalTrials.gov lists more than 16 phase 2–4 xanomeline-trospium trials. This page tracks the 16 largest by enrolment: 0 phase 2, 16 phase 3, and 0 phase 4 among them, with 12 actively recruiting. Updated daily.
- Where does this data come from?
- All trial data is sourced from ClinicalTrials.gov (CTGov) and refreshed on this page daily.
- Can I compare xanomeline-trospium against other drugs?
- Yes. The free ComplyRx Trial Pipeline tool compares up to five drugs side by side on one timeline, with PNG and PDF export. Add any competitor in the search box above.
Join the waitlist
Be the first to access ComplyRx
We'll let you know as soon as your spot opens to use ComplyRx.
By joining, you agree to our Privacy Policy.