Table 1. Open in new tab...

Trial

Development phase

Population

Trial description

Status

EMERGENT-1

Phase 2

Schizophrenia

5-week, randomized, double-blind, placebo-controlled, inpatient trial
(acute efficacy and safety; NCT03697252)

Completed, results published

EMERGENT-2

Phase 3

Schizophrenia

5-week, randomized, double-blind, placebo-controlled, inpatient trial
(acute efficacy and safety; NCT04659161)

Completed, results published

EMERGENT-3

Phase 3

Schizophrenia

5-week, randomized, double-blind, placebo-controlled, inpatient trial
(acute efficacy and safety; NCT04738123)

Completed, results published

EMERGENT-4

Phase 3

Schizophrenia

52-week, open-label extension trial of EMERGENT-2 and EMERGENT-3
(long-term safety; NCT04659174)

Completed

EMERGENT-5

Phase 3

Schizophrenia

52-week, open-label trial
(long-term safety; NCT04820309)

Completed

ARISE

Phase 3

Schizophrenia

6-week, randomized, double-blind, placebo-controlled trial of adjunctive xanomeline/trospium in people with inadequately controlled symptoms of schizophrenia (efficacy and safety of adjunctive xanomeline/trospium; NCT051453413)

Ongoing

ARISE OLE

Phase 3

Schizophrenia

52-week, outpatient, open-label extension trial of ARISE
(long-term safety and tolerability of adjunctive xanomeline/trospium; NCT05304767)

Ongoing

ADEPT-1

Phase 3

Psychosis in Alzheimer’s Disease

12-week, single-blind treatment period followed by 26-week, double-blind,
placebo-controlled, randomized withdrawal period
(relapse prevention; NCT05511363)

Ongoing

ADEPT-2

Phase 3

Psychosis in Alzheimer’s Disease

12-week, double-blind, placebo-controlled trial
(acute efficacy; NCT06126224)

Ongoing

ADEPT-3

Phase 3

Psychosis in Alzheimer’s Disease

52-week, open-label extension trial of ADEPT-1 and ADEPT-2
(long-term efficacy and safety; NCT05980949)

Ongoing

ADEPT-4

Phase 3

Psychosis in Alzheimer’s Disease

12-week, double-blind, placebo-controlled trial (acute efficacy; NCT06585787)

Ongoing

Table 1.

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Xanomeline/trospium core clinical development program.

Trial	Development phase	Population	Trial description	Status
EMERGENT-1	Phase 2	Schizophrenia	5-week, randomized, double-blind, placebo-controlled, inpatient trial (acute efficacy and safety; NCT03697252)	Completed, results published
EMERGENT-2	Phase 3	Schizophrenia	5-week, randomized, double-blind, placebo-controlled, inpatient trial (acute efficacy and safety; NCT04659161)	Completed, results published
EMERGENT-3	Phase 3	Schizophrenia	5-week, randomized, double-blind, placebo-controlled, inpatient trial (acute efficacy and safety; NCT04738123)	Completed, results published
EMERGENT-4	Phase 3	Schizophrenia	52-week, open-label extension trial of EMERGENT-2 and EMERGENT-3 (long-term safety; NCT04659174)	Completed
EMERGENT-5	Phase 3	Schizophrenia	52-week, open-label trial (long-term safety; NCT04820309)	Completed
ARISE	Phase 3	Schizophrenia	6-week, randomized, double-blind, placebo-controlled trial of adjunctive xanomeline/trospium in people with inadequately controlled symptoms of schizophrenia (efficacy and safety of adjunctive xanomeline/trospium; NCT051453413)	Ongoing
ARISE OLE	Phase 3	Schizophrenia	52-week, outpatient, open-label extension trial of ARISE (long-term safety and tolerability of adjunctive xanomeline/trospium; NCT05304767)	Ongoing
ADEPT-1	Phase 3	Psychosis in Alzheimer’s Disease	12-week, single-blind treatment period followed by 26-week, double-blind, placebo-controlled, randomized withdrawal period (relapse prevention; NCT05511363)	Ongoing
ADEPT-2	Phase 3	Psychosis in Alzheimer’s Disease	12-week, double-blind, placebo-controlled trial (acute efficacy; NCT06126224)	Ongoing
ADEPT-3	Phase 3	Psychosis in Alzheimer’s Disease	52-week, open-label extension trial of ADEPT-1 and ADEPT-2 (long-term efficacy and safety; NCT05980949)	Ongoing
ADEPT-4	Phase 3	Psychosis in Alzheimer’s Disease	12-week, double-blind, placebo-controlled trial (acute efficacy; NCT06585787)	Ongoing

Trial	Development phase	Population	Trial description	Status
EMERGENT-1	Phase 2	Schizophrenia	5-week, randomized, double-blind, placebo-controlled, inpatient trial (acute efficacy and safety; NCT03697252)	Completed, results published
EMERGENT-2	Phase 3	Schizophrenia	5-week, randomized, double-blind, placebo-controlled, inpatient trial (acute efficacy and safety; NCT04659161)	Completed, results published
EMERGENT-3	Phase 3	Schizophrenia	5-week, randomized, double-blind, placebo-controlled, inpatient trial (acute efficacy and safety; NCT04738123)	Completed, results published
EMERGENT-4	Phase 3	Schizophrenia	52-week, open-label extension trial of EMERGENT-2 and EMERGENT-3 (long-term safety; NCT04659174)	Completed
EMERGENT-5	Phase 3	Schizophrenia	52-week, open-label trial (long-term safety; NCT04820309)	Completed
ARISE	Phase 3	Schizophrenia	6-week, randomized, double-blind, placebo-controlled trial of adjunctive xanomeline/trospium in people with inadequately controlled symptoms of schizophrenia (efficacy and safety of adjunctive xanomeline/trospium; NCT051453413)	Ongoing
ARISE OLE	Phase 3	Schizophrenia	52-week, outpatient, open-label extension trial of ARISE (long-term safety and tolerability of adjunctive xanomeline/trospium; NCT05304767)	Ongoing
ADEPT-1	Phase 3	Psychosis in Alzheimer’s Disease	12-week, single-blind treatment period followed by 26-week, double-blind, placebo-controlled, randomized withdrawal period (relapse prevention; NCT05511363)	Ongoing
ADEPT-2	Phase 3	Psychosis in Alzheimer’s Disease	12-week, double-blind, placebo-controlled trial (acute efficacy; NCT06126224)	Ongoing
ADEPT-3	Phase 3	Psychosis in Alzheimer’s Disease	52-week, open-label extension trial of ADEPT-1 and ADEPT-2 (long-term efficacy and safety; NCT05980949)	Ongoing
ADEPT-4	Phase 3	Psychosis in Alzheimer’s Disease	12-week, double-blind, placebo-controlled trial (acute efficacy; NCT06585787)	Ongoing

Abbreviation: OLE, open-label extension.

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