Developer

Karuna Therapeutics

1compound
2programs
2indications
Approvedlead asset

Phase distribution

  • Approved1
  • Phase 31

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Deals & partnerships

  • Mar 18, 2024AcquisitionBristol Myers Squibb completes its $14.0 billion acquisition of Karuna TherapeuticsBMS acquired all outstanding shares of Karuna Therapeutics for $330.00 per share in cash — $14.0 billion total ($12.9 billion net of cash acquired) — making Karuna a wholly owned subsidiary. Announced 2023-12-22; completed 2024-03-18. The deal was built around KarXT, then under FDA review for schizophrenia with a 2024-09-26 PDUFA date.Xanomeline/trospium chloride (Cobenfy)source ↗
  • Nov 8, 2021Licensing dealKaruna licenses KarXT Greater China rights to Zai Lab ($35M upfront)Karuna Therapeutics and Zai Lab entered an exclusive license for the development, manufacturing and commercialization of KarXT in Greater China (mainland China, Hong Kong, Macau, Taiwan): $35.0M upfront, up to $80.0M development/regulatory and $72.0M sales milestones, plus low-double-digit to high-teens tiered royalties. Zai Lab funds substantially all activities in the territory. Agreement dated 2021-11-08; announced 2021-11-09. This deal is what later carried Cobenfy to its China approval in December 2025.Xanomeline/trospium chloride (Cobenfy)source ↗

Catalysts · 3 upcoming · 4 reported

Recently reported

  • 2025-04-22missed

    Xanomeline/trospium chloride (Cobenfy)forSchizophreniaTopline data

    ARISE (Phase 3, adjunctive to atypical antipsychotics) MISSED its primary endpoint: Cobenfy added to an atypical antipsychotic reduced PANSS total score by 2.0 points vs placebo+antipsychotic at week 6, not statistically significant (p=0.11).

    source ↗

  • 2023-03-20met

    Xanomeline/trospium chloride (Cobenfy)forSchizophreniaTopline data

    EMERGENT-3 (Phase 3) topline positive: KarXT met the primary endpoint with an 8.4-point reduction in PANSS total score vs placebo at week 5, the third consecutive positive registrational trial.

    source ↗

  • 2022-08-08met

    Xanomeline/trospium chloride (Cobenfy)forSchizophreniaTopline data

    EMERGENT-2 (Phase 3) topline positive: KarXT met the primary endpoint with a statistically significant 9.6-point reduction in PANSS total score vs placebo at week 5 (p<0.0001), and met key secondary endpoints on PANSS positive, negative and Marder negative-factor subscales.

    source ↗

  • 2021-02-25met

    Xanomeline/trospium chloride (Cobenfy)forSchizophreniaFull results

    EMERGENT-1 (Phase 2) published in NEJM: xanomeline-trospium reduced PANSS total score by 11.6 points more than placebo at week 5 (p<0.001) in 182 hospitalized adults with acute schizophrenia, without D2-antagonist-typical adverse events.

    source ↗

Recent activity

  • Dec 3, 2025Phase changeXanomeline/trospium chloride (Cobenfy)·Alzheimer's disease psychosisPhase 3ADEPT-2 continuation announcement: BMS identified 'irregularities due to clinical trial execution at a small number of study sites', excluded those sites' patient data from the primary analysis, had an independent party assess the collected data, and per the Data Monitoring Committee's recommendation continued the trial with additional enrollment (BMS remaining blinded). ADEPT-1/-2/-4 readouts guided to end-2026 at that time; on 2026-07-30 (Q2 2026 earnings) guidance moved again to topline readouts beginning early 2027, spread across the year. Phase and status unchanged — recorded because the enrollment extension and readout slips are material program events with no fitting event_type code.source ↗
  • Apr 22, 2025ReadoutXanomeline/trospium chloride (Cobenfy)·SchizophreniamissedARISE (Phase 3, adjunctive to atypical antipsychotics) MISSED its primary endpoint: Cobenfy added to an atypical antipsychotic reduced PANSS total score by 2.0 points vs placebo+antipsychotic at week 6, not statistically significant (p=0.11).source ↗
  • Sep 26, 2024Phase changeXanomeline/trospium chloride (Cobenfy)·SchizophreniaApprovedFDA approved COBENFY (xanomeline and trospium chloride) capsules, NDA 216158, for the treatment of schizophrenia in adults, on the PDUFA date. First-in-class muscarinic antipsychotic; openFDA records the original approval as a TYPE 1 (new molecular entity) submission by Bristol-Myers Squibb.source ↗
  • Sep 30, 2023Phase changeXanomeline/trospium chloride (Cobenfy)·SchizophreniaFiled (NDA)Karuna submitted the NDA for KarXT for schizophrenia in adults in September 2023 (exact day not disclosed in the acceptance release; dated month-end as an upper bound). FDA accepted the NDA on 2023-11-29 and set a PDUFA action date of 2024-09-26. Supported by EMERGENT-1/-2/-3 (efficacy) and EMERGENT-4/-5 (long-term safety).source ↗
  • Mar 20, 2023ReadoutXanomeline/trospium chloride (Cobenfy)·SchizophreniametEMERGENT-3 (Phase 3) topline positive: KarXT met the primary endpoint with an 8.4-point reduction in PANSS total score vs placebo at week 5, the third consecutive positive registrational trial.source ↗
  • Aug 23, 2022Phase changeXanomeline/trospium chloride (Cobenfy)·Alzheimer's disease psychosisPhase 3ADEPT-1 (NCT05511363, CN012-0026) started per ClinicalTrials.gov: the ADP program opened directly in Phase 3 with a randomized-withdrawal relapse-prevention design (open-label KarXT, then randomization to continue or withdraw; primary endpoint time from randomization to relapse over 38 weeks). Started under Karuna Therapeutics, pre-acquisition.source ↗
  • Aug 8, 2022ReadoutXanomeline/trospium chloride (Cobenfy)·SchizophreniametEMERGENT-2 (Phase 3) topline positive: KarXT met the primary endpoint with a statistically significant 9.6-point reduction in PANSS total score vs placebo at week 5 (p<0.0001), and met key secondary endpoints on PANSS positive, negative and Marder negative-factor subscales.source ↗
  • Feb 25, 2021ReadoutXanomeline/trospium chloride (Cobenfy)·SchizophreniametEMERGENT-1 (Phase 2) published in NEJM: xanomeline-trospium reduced PANSS total score by 11.6 points more than placebo at week 5 (p<0.001) in 182 hospitalized adults with acute schizophrenia, without D2-antagonist-typical adverse events.source ↗
  • Dec 16, 2020Phase changeXanomeline/trospium chloride (Cobenfy)·SchizophreniaPhase 3EMERGENT-2 (NCT04659161, KAR-007) started: first Phase 3, 252 acutely psychotic hospitalized adults, PANSS total at week 5. Topline positive 2022-08-08 (-9.6 points vs placebo, p<0.0001); published in The Lancet 2024-01-13. EMERGENT-3 (NCT04738123) followed in April 2021 and read out positive 2023-03-20 (-8.4 points).source ↗
  • Sep 18, 2018Phase changeXanomeline/trospium chloride (Cobenfy)·SchizophreniaPhase 2EMERGENT-1 (NCT03697252, KAR-004) started: Phase 2, randomized, double-blind, placebo-controlled, 182 hospitalized adults with acute schizophrenia; primary endpoint change in PANSS total at week 5. Positive: -11.6 points vs placebo (published NEJM 2021-02-25). Xanomeline itself had earlier Lilly-era clinical history in the 1990s; this history starts with the KarXT combination.source ↗

Trials recruiting · 1 recruiting of 2 sponsored

  • Phase 3KarXTn=40058 sites · United States, Japan, Poland

    A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

    SchizophreniaAutism-Related IrritabilityNCT07424404 ↗

Competitive landscape

Other companies developing against Karuna Therapeutics's targets or indications.