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ACP-104

Phase 2

Schizophrenia | Small molecule | Psychiatry |ACADIA Pharmaceuticals Inc.|Last Updated: Jan 20, 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 Enrollment292
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00490516ACP-104 in Acutely Psychotic Subjects With SchizophreniaPHASE2 COMPLETED 247Jun 1, 2007Feb 1, 2008Jan 20, 202521 United States
NCT00628420Safety Study of ACP-104: To Demonstrate the Safety, Tolerability, and PharmacokineticsPHASE1 COMPLETED 45Jan 1, 2005Oct 1, 2007Jun 28, 20112 United States
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Study Endpoints
Primary Endpoints
PANSS
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ACP-104DRUG200 mg, tablet, BID, 6 weeks
PlaceboDRUGplacebo, tablet BID, 6 weeks
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Male or female; 18-60 years of age * The subject is physically healthy and medically stable. * The subject is able to provide informed consent * The subject has been diagnosed with schizophrenia for at least 1 year * Currently experiencing an acute episode of psychosis * The s...

Countries:United States
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