# An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)

Clinical trial · Karuna Therapeutics, Inc., a Bristol Myers Squibb company

- Archive id: nct:NCT04820309
- Published: 2021-03-29
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT04820309
- Source URL: https://clinicaltrials.gov/study/NCT04820309
- Provenance: clinicaltrials

## Abstract

This is a Phase 3, multicenter, 56-week, outpatient, open-label (OL) study to evaluate the long-term safety, tolerability, and efficacy of KarXT in de novo subjects with Diagnostic and Statistical Manual-Fifth Edition (DSM-5) schizophrenia. In this OL study, all subjects will receive KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily \\\[BID\\\]) for up to 52 weeks. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a DSM-5 diagnosis of schizophrenia. The secondary objective of this study is to assess the long-term efficacy and characterize the pharmacokinetics of xanomeline and trospium after administration of KarXT.

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- status: COMPLETED
- phase: PHASE3
- study type: INTERVENTIONAL
- enrollment: 566
- sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- conditions: Schizophrenia
- interventions: DRUG: Xanomeline and Trospium Chloride Capsules
- start date: 2021-06-02
- start date type: ACTUAL
- primary completion date: 2024-05-24
- has results: true
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Novel Psychiatric Therapeutics](https://space-kitty.com/topics/psychiatric-therapeutics)

Cited in dossiers:
- [Novel Psychiatric Therapeutics: State of the Field (October 2026)](https://space-kitty.com/dossiers/psychiatric-therapeutics)

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