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Cariprazine

Phase 3

Autism Spectrum Disorder | Small molecule | Psychiatry |AbbVie Inc.|Last Updated: Apr 4, 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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment185
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05439616Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASDPHASE3 COMPLETED 161 — — Jul 7, 2022Oct 4, 2024Apr 4, 202536 United States, Puerto Rico
NCT04382885Cariprazine Pediatric ASD PK StudyPHASE1 COMPLETED 24 — — Jun 26, 2020Dec 10, 2021Apr 12, 20223 United States
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Study Endpoints
Primary Endpoints
Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score
Baseline (Week 0) to Week 8

The Aberrant Behavior Checklist (ABC) - Community version is a 58-item, caregiver-rated scale designed to measure inappropriate and maladaptive behavior of people with developmental disabilities (including intellectual disability and ASD). The ABC has 5 subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity and Inappropriate Speech). The caregiver rates the child's behavior from 0=not at all a problem to 3= the problem is severe in degree. The range for Irritability is 0 to 45. Higher scores indicate greater severity.

Incidence of Adverse Events (AEs)
Up to 30 days after last visit or last dose for participants who discontinue early
Incidence of Serious Adverse Events (SAEs)
Up to 30 days after last visit or last dose for participants who discontinue early
Incidence of AEs leading to discontinuation
Up to 30 days after last visit or last dose for participants who discontinue early
Percentage of participants with potentially clinically significant values in clinical laboratory assessments
Up to 84 days
Percentage of participants with potentially clinically significant values in vital signs assessments
Up to 84 days
Percentage of participants with potentially clinically significant values in ECG assessments
Up to 84 Days
Percentage of participants who have suicidal ideation or suicidal behaviors in C-SSRS assessments
Up to 84 Days
Percentage of participants with treatment-emergent parkinsonism in SAS assessments
Up to 84 Days
Percentage of participants with treatment-emergent akathisia in BARS assessments
Up to 84 days
Percentage of participants with potentially clinically significant values in ocular examination parameters
Screening to Day 84
Pharmacokinetics: Maximum plasma concentrations (Cmax) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42
Day 1 and Day 42
Pharmacokinetics: Time of maximum plasma concentrations (Tmax) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42
Day 1 and Day 42
Pharmacokinetics: Area under the plasma concentration-time curve during the dosing interval (AUC0-tau) of cariprazine and its metabolites DCAR and DDCAR on Days 1 and 42
Day 1 and Day 42
Pharmacokinetics: Terminal elimination half-life (T1/2) of cariprazine and its metabolites DCAR and DDCAR
Day 42 to Day 84
Pharmacokinetics: Minimum plasma concentrations (Cmin) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42
Day 42
Pharmacokinetics: Average plasma concentrations (Cavg) during the dosing interval of cariprazine and its metabolites DCAR and DDCAR on Day 42
Day 42
Pharmacokinetics: Apparent total clearance of cariprazine from plasma (CL/F) on Day 42
Day 42
Pharmacokinetics: Volume of distribution during the terminal elimination phase (Vz/F) of cariprazine
Day 42 to Day 84
Secondary Endpoints
Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale
Week 8
Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score
Baseline (Week 0) to Week 8
Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score
Baseline (Week 0) to Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CariprazineEXPERIMENTALParticipants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo once daily for 8-weeks.
Cohort 1 (10-17 years)EXPERIMENTAL10 to 12 years: 0.75 mg/day cariprazine oral solution 13 to 17 years: 1.5 mg/day cariprazine oral solution
Cohort 2 (10-17 years)EXPERIMENTAL10 to 12 years: 1.5 mg/day cariprazine oral solution 13 to 17 years: 3.0 mg/day cariprazine oral solution
Cohort 3 (5-9 years)EXPERIMENTAL0.5 mg/day cariprazine oral solution
Cohort 4 (5-9 years)EXPERIMENTAL1.5 mg/day cariprazine oral solution
Interventions
NameTypeDescription
CariprazineDRUGOral Capsules or Oral Solution
PlaceboDRUGOral capsules or Oral Solution
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Eligibility Criteria
Age Range5 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Participants at the time of screening must have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL) administered at screening (V...

Countries:United StatesPuerto Rico
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Competitive Landscape -Autism Spectrum Disorder 17 trials
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Bristol-Myers Squibb CompanyBMY3PHASE3KarXT, KarX-EC
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Definium Therapeutics, Inc.DFTX1PHASE2DT402 )
Plus Therapeutics, Inc.PSTV1NAUndisclosed
SciSparc Ltd.SPRC1NASCI-210, CBD oil
Journey Medical Corp.DERM1 — Undisclosed
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