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GXV813

Phase 2

Schizophrenia | Small molecule | Psychiatry |Novartis AG|Last Updated: May 14, 2026

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment142
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07467993Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With SchizophreniaPHASE2 RECRUITING 142Mar 16, 2026Apr 22, 2027May 14, 20267 United States
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Study Endpoints
Primary Endpoints
Change from baseline in Positive and Negative Symptom Scale (PANSS) total score
Baseline, Week 6

PANSS is a 30-item rating scale used to assess the positive, negative, and general psychopathy symptoms of schizophrenia. PANSS total score ranges from 30 to 120 , where a higher score indicates greater severity.

Secondary Endpoints
Number of participants with AEs
Baseline to 6 weeks
Participant clinically significant response
Baseline, week 6
Change from baseline in PANSS positive sub-score
Baseline, week 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GXV813EXPERIMENTALGXV813 administered orally.
PlaceboPLACEBO_COMPARATORPlacebo administered orally.
Interventions
NameTypeDescription
GXV813DRUGGXV813 administered orally.
PlaceboDRUGPlacebo administered orally.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Participant is aged 18 to 65 years, inclusive, at screening 2. Participant is capable of providing informed consent 3. Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Associat...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07467993primaryCompletionDate: changed
LOWMay 24, 2026NCT07467993studyFirstPostDate: changed