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Emraclidine

Phase 2

Schizophrenia | Small molecule | Psychiatry |AbbVie Inc.|Last Updated: Jul 13, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment1,044
FDA Designations
No designations recorded
Clinical trial landscape

Emraclidine · 12 trials · 8 indications

Phase 2 3Phase 1 9
NCT07145918A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With SchizophreniaSchizophrenia
RECRUITING268 Analytics
NCT05227703A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With SchizophreniaSchizophrenia
COMPLETED391 Analytics
NCT05227690A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With SchizophreniaSchizophrenia
COMPLETED385 Analytics
PHASE2RECRUITING
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
SchizophreniaUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AEs)
Up to approximately 74 days

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Up to approximately 24 days

Cmax of Emraclidine

Part A Only-Time to Cmax (Tmax) of Emraclidine
Up to approximately 24 days

Tmax of Emraclidine

Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
Up to approximately 24 days

AUCt of Emraclidine

Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
Up to approximately 24 days

AUCtau of Emraclidine

Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine
Up to approximately 21 days

MRCmax of Emraclidine

Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine
Up to approximately 21 days

MRAUCtau of Emraclidine

Part A Only- Minimum plasma concentration (Cmin) of Emraclidine
Up to approximately 21 days

Cmin of Emraclidine

Part A Only-Average plasma concentration (Cavg) of Emraclidine
Up to approximately 21 days

Cavg of Emraclidine

Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Up to approximately 21 days

Terminal phase elimination half-life of Emraclidine

Part A Only-Terminal elimination rate constant (λz) of Emraclidine
Up to approximately 21 days

λz of Emraclidine

Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
Up to approximately 21 days

CL/F of Emraclidine

Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Up to approximately 21 days

Vz/F of Emraclidine

Part A Only-Peak-to-trough ratio (PTR) of Emraclidine
Up to approximately 21 days

PTR of Emraclidine

Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine
Up to approximately 21 days

RacCmax of Emraclidine

Part A Only-Accumulation ratio for AUCta (RacAUCtau) of Emraclidine
Up to approximately 21 days

RacAUCta of Emraclidine

Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Up to approximately 24 days

Cmax of Metabolite (CV-0000364)

Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)
Up to approximately 24 days

Tmax of Metabolite (CV-000036)

Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036)
Up to approximately 24 days

AUCtau of Metabolite (CV-000036)

Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
Up to approximately 24 days

AUCt of Metabolite (CV-000036)

Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036)
Up to approximately 21 days

MRCmax of Metabolite (CV-000036)

Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036)
Up to approximately 21 days

MRAUCtau of Metabolite (CV-000036)

Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
Up to approximately week 6

PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.

Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score
Baseline through Week 6

The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Up to approximately 14 days

Cmax of Emraclidine.

Time to Cmax (Tmax) of Emraclidine
Up to approximately 14 days

Tmax of Emraclidine.

Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine
Up to approximately 14 days

AUC of Emraclidine.

Number of Participants Experiencing Adverse Events
Up to approximately 50 days

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements
Up to approximately 20 days

Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)
Up to approximately 20 days

12-lead resting ECG will be recorded.

Number of Participants with Clinical Significant Change in Physical Examinations
Up to approximately 20 days

Number of participants with clinical significant change in physical examinations will be assessed.

Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Up to approximately 20 days

Number of participants with clinical significant change in clinical laboratory test results will be assessed.

Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to approximately 20 days

The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Up to approximately 20 days

AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.

Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Up to approximately 20 days

BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal \[0\] to severe \[3\]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent \[0\] to severe akathisia \[5\]).

Change From Baseline in Simpson-Angus Scale (SAS)
Up to approximately 20 days

SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.

Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Up to approximately 20 days

Cmax of Metabolite (CV-0000364)

Time to Cmax (Tmax) of Metabolite (CV-0000364)
Up to approximately 20 days

Tmax of Metabolite (CV-000036)

Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
Up to approximately 20 days

AUCt of Emraclidine

Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
Up to approximately 20 days

AUCt of Metabolite (CV-000036)

Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
Up to approximately 20 days

AUCtau of Emraclidine

Minimum plasma concentration (Cmin) of Emraclidine
Up to approximately 20 days

Cmin of Emraclidine

Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)
Up to approximately 20 days

Cmin of Metabolite (CV-0000364)

Average plasma concentration (Cavg) of Emraclidine
Up to approximately 20 days

Cavg of Emraclidine

Average plasma concentration (Cavg) of Metabolite (CV-0000364)
Up to approximately 20 days

Cavg of Metabolite (CV-0000364)

Metabolite to Parent Ratio (MRCmax) of Emraclidine
Up to approximately 20 days

MRCmax of Emraclidine calculated from Cmax

Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)
Up to approximately 20 days

MRCmax of Metabolite (CV-0000364) calculated from Cmax

Metabolite to Parent Ratio (MRAUCtau) of Emraclidine
Up to approximately 20 days

MRAUCtau of Emraclidine based on AUCtau

Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)
Up to approximately 20 days

MRAUCtau of Metabolite (CV-000036) based on AUCtau

Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Up to approximately 20 days

Terminal phase elimination half-life of Emraclidine

Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036)
Up to approximately 20 days

Terminal phase elimination half-life of Metabolite (CV-000036)

Apparent terminal phase elimination constant (β) of Emraclidine
Up to approximately 20 days

β of Emraclidine

Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)
Up to approximately 20 days

β of Metabolite (CV-0000364)

Peak-to-trough ratio (PTR) of Emraclidine
Up to approximately 20 days

PTR of Emraclidine

Peak-to-trough ratio (PTR) of Metabolite (CV-000036)
Up to approximately 20 days

PTR of Metabolite (CV-000036)

Accumulation ratio for Cmax (RacCmax) of Emraclidine
Up to approximately 20 days

RacCmax of Emraclidine

Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)
Up to approximately 20 days

RacCmax of Metabolite (CV-0000364)

Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
Up to approximately 20 days

RacAUCtau of Emraclidine

Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)
Up to approximately 20 days

RacAUCtau of Metabolite (CV-0000364)

Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
Up to approximately 20 days

CL/F of Emraclidine

Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Up to approximately 20 days

Vz/F of Emraclidine

Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)
Up to approximately 20 days

AUCtau of Metabolite (CV-0000364)

Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine
Pre-dose and at multiple timepoints post-dose up to Day 5
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine
Pre-dose and at multiple timepoints post-dose up to Day 5
Area Under the Unbound Plasma Concentration-time Curve from Time Zero to t (AUC0-t,u) of Emraclidine
Pre-dose and at multiple timepoints post-dose up to Day 5
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine
Pre-dose and at multiple timepoints post-dose up to Day 5
Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine
Pre-dose and at multiple timepoints post-dose up to Day 5
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to Day 28
Part A: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Up to Day 17
Part A: Number of Participants With Clinically Significant Changes in Laboratory Assessments
Up to Day 17
Part A: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Up to Day 17
Part A: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Up to Day 17
Part A: Changes in Suicidality Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to Day 17

The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.

Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Simpson Angus Scale (SAS)
Up to Day 14

The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.

Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)
Up to Day 14

The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status.

Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Barnes Akathisia Rating Scale (BARS)
Up to Day 14

The BARS consists of 4 items related to akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.

Part B: Number of Participants With TEAEs, Clinically Significant Changes in ECG Parameters, Laboratory Assessments, Vital Sign Measurements, and Physical and Neurological Examination Results
Up to Day 28
Part B: Changes in Suicidality Assessed Using the C-SSRS
Up to Day 28
Part B: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms
Up to Day 28

Extrapyramidal symptoms will be evaluated using SAS, AIMS, and BARS scales.

Secondary Endpoints
Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score
Up to approximately Week 6
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
Up to approximately 74 days
Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score
Up to approximately week 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Emraclidine Part AEXPERIMENTALParticipants will be assigned to received one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period.
Placebo-Part AEXPERIMENTALParticipants will be assigned to received one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period.
Emraclidine-Part BEXPERIMENTALParticipants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period.
Placebo-Part BEXPERIMENTALParticipants will receive placebo for 42 days followed by a 30-day safety follow-up period.
CVL-231 15 mg, once daily (QD)EXPERIMENTALOral Dose
CVL-231 30 mg, once daily (QD)EXPERIMENTALOral Dose
Placebo, once daily (QD)PLACEBO_COMPARATOROral Dose
PlaceboPLACEBO_COMPARATORParticipants received placebo tablets orally once daily (QD) through Day 45 of Week 6.
Emraclidine 10 mg, once daily (QD)EXPERIMENTALParticipants received emraclidine 10 mg tablets orally once daily (QD) through Day 45 of Week 6.
Emraclidine 30 mg, once daily (QD)EXPERIMENTALParticipants received emraclidine 30 mg tablets orally once daily (QD) through Day 45 of Week 6.
Sequence 1EXPERIMENTALParticipants will receive Emraclidine in 3 different formulations in Sequence 1.
Sequence 2EXPERIMENTALParticipants will receive Emraclidine in 3 different formulations in Sequence 2.
Sequence 3EXPERIMENTALParticipants will receive Emraclidine in 3 different formulations in Sequence 3.
Sequence 4EXPERIMENTALParticipants will receive Emraclidine in 3 different formulations in Sequence 4.
Sequence 5EXPERIMENTALParticipants will receive Emraclidine in 3 different formulations in Sequence 5.
Sequence 6EXPERIMENTALParticipants will receive Emraclidine in 3 different formulations in Sequence 6.
Emraclidine or Placebo- Group 1EXPERIMENTALParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days
Emraclidine or Placebo- Group 2EXPERIMENTALParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days
Emraclidine or Placebo- Group 3EXPERIMENTALParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Emraclidine or Placebo- Group 4EXPERIMENTALParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Emraclidine or Placebo- Group 5EXPERIMENTALParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Mild Renal ImpairmentEXPERIMENTALParticipants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1.
Moderate Renal ImpairmentEXPERIMENTALParticipants will receive a single oral dose of 10 mg emraclidine on Day 1.
Severe Renal ImpairmentEXPERIMENTALParticipants will receive a single oral dose of 10 mg emraclidine on Day 1.
Normal Renal FunctionEXPERIMENTALParticipants will receive a single oral dose of 10 mg emraclidine on Day 1.
Severe Hepatic ImpairmentEXPERIMENTALParticipants will receive a single oral dose of 10 milligrams (mg) emraclidine.
Moderate Hepatic ImpairmentEXPERIMENTALParticipants will receive a single oral dose of 10 mg emraclidine.
Mild Hepatic ImpairmentEXPERIMENTALParticipants will receive a single oral dose of 10 mg emraclidine.
Normal Hepatic FunctionEXPERIMENTALParticipants will receive a single oral dose of 10 mg emraclidine.
Part A: Cohort 1: Emraclidine Dose 1EXPERIMENTALParticipants will receive emraclidine dose 1 or emraclidine-matching placebo tablets, orally, once daily (QD) up to Day 14.
Part A: Cohort 2: Emraclidine Dose 2EXPERIMENTALParticipants will receive emraclidine dose 2 or emraclidine-matching placebo tablets, orally, QD up to Day 14.
Part A: Cohort 3: Emraclidine Dose 3EXPERIMENTALParticipants will receive emraclidine dose 3 or emraclidine-matching placebo tablets, orally, QD up to Day 14.
Part A: Cohort 4: Emraclidine Dose 4EXPERIMENTALParticipants will receive emraclidine dose 4 or emraclidine-matching placebo tablets, orally, QD up to Day 14.
Part A: Cohort 5: Emraclidine Dose 5EXPERIMENTALParticipants will receive emraclidine dose 5 or emraclidine-matching placebo tablets, orally, QD up to Day 14.
Part B: Cohort 6: Emraclidine Dose 6EXPERIMENTALParticipants with dementia due to AD will receive emraclidine dose 6 or emraclidine-matching placebo tablets, orally, QD up to Day 28.
Interventions
NameTypeDescription
EmraclidineDRUGOral Tablets
PlaceboDRUGOral Tablets
Emraclidine 15 mgDRUGEmraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks
Emraclidine 30 mgDRUGEmraclidine 30 mg, oral (tablet), QD for 6 weeks
Emraclidine 10 mgDRUGEmraclidine 10 mg, oral (tablet), once per day for 6 weeks
EsomeprazoleDRUGOral delayed-release capsule
ItraconazoleDRUGItraconazole oral solution.
CarbamazepineDRUGCarbamazepine tablets.
MetforminDRUGMetformin tablets.
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight \> 50 kg (110 lbs). * (Part A only): Positive and Negative Syndrome Scale (PANSS) total score \< 80 at Screening and at Baseline * (Part B only): Participant experiencing an acute exacerbation of psychotic s...

Countries:United StatesBulgariaHungary
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Recent Changes (Last 90 Days)
MEDIUMJul 13, 2026NCT07587008Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 13, 2026NCT07587008Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 16, 2026NCT07587008Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07587008Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07587008Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 16, 2026NCT07587008Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07145918primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT07219030Enrollment: 32 → 40
LOWMay 24, 2026NCT07145918studyFirstPostDate: changed
LOWMay 24, 2026NCT07219030studyFirstPostDate: changed
LOWMay 24, 2026NCT07587008studyFirstPostDate: changed
LOWMay 21, 2026NCT07587008NEW_TRIAL: changed
LOWMay 21, 2026NCT07587008NEW_TRIAL: changed