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CVL-231

Phase 2

Schizophrenia | Small molecule | Psychiatry |AbbVie Inc.|Last Updated: Jul 28, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials3
Total Enrollment845
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05443724A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With SchizophreniaPHASE2 COMPLETED 700 — — Sep 2, 2022Jun 25, 2025Jul 28, 202585 United States, Bulgaria +3
NCT04787302PET Trial to Evaluate Target Occupancy of CVL-231 on Brain Receptors Following Oral DosingPHASE1 COMPLETED 15 — — May 1, 2021Jul 1, 2023Jul 26, 2023 - —
NCT04136873A Multiple Ascending Dose Trial of CVL-231 in Subjects With SchizophreniaPHASE1 COMPLETED 130 — — Oct 1, 2019Jun 1, 2021Jul 1, 2021 - —
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Week 56
Number of Participants With Clinically Significant Changes in Vital Sign Values
Up to Week 52
Number of Participants With Clinically Significant Changes in Body Weight
Up to Week 52
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Up to Week 52
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Up to Week 52
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Up to Week 52
Number of Participants With Clinically Significant Changes in Metabolic Parameter Values
Up to Week 52
Number of Participants With Clinically Significant Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score
Baseline up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score
Baseline up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score
Baseline up to Week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CVL-231 30 mgEXPERIMENTALParticipants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks.
Interventions
NameTypeDescription
CVL-231 30 mgDRUGOral tablets
CVL-231DRUGCohort 1: 30mg dose of CVL-231
Matching PlaceboDRUGPlacebo matching CVL-231
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites85

Inclusion Criteria: 1. Completed 6 weeks of post-randomization treatment in Trial CVL-231-2001 (NCT05227690) or CVL-231-2002 (NCT05227703) and who, in the opinion of the investigator, could potentially benefit from treatment with emraclidine for schizophrenia. 2. Primary diagnosis of schizophrenia ...

Countries:United StatesBulgariaHungaryPuerto RicoUkraine
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Competitive Landscape -Schizophrenia 38 trials
CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568, NBI-1117570
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC, Xanomeline and Trospium Chloride, xanomeline and trospium chloride therapy, Xanomeline and trospium chloride
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM, Olanzapine
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Novartis AG Sponsored ADRNVS1PHASE2GXV813
MapLight Therapeutics, Inc.MPLT2PHASE2ML-007C-MA
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Unity Health TorontoUBX1NAUndisclosed
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