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Brilaroxazine

Phase 3

Schizophrenia | Small molecule | Psychiatry |Reviva Pharmaceuticals Holdings, Inc.|Last Updated: Dec 18, 2024

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
UNCONTROLLED
Total Trials1
Total Enrollment690
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05184335Safety and Efficacy of Brilaroxazine (RP5063) in SchizophreniaPHASE3 RECRUITING 690Jan 1, 2022Feb 1, 2025Dec 18, 2024 -
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Study Design & Arms
Interventions
NameTypeDescription
BrilaroxazineDRUGRP5063, a new chemical entity (NCE), is a novel multimodal neuromodulator intended for treating schizophrenia and comorbid conditions. This drug is an investigational drug and has not been approved for treatment or marketing. RP5063 belongs to a class of third generation antipsychotics called Dopamine-Serotonin System Stabilizers. The chemical name of the RP5063 active pharmaceutical ingredient (API) is 6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzo\[b\]\[1,4\]oxazin-3(4H)-one hydrochloride.
PlaceboOTHERRP5063 matching Placebo
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05184335studyFirstPostDate: changed