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GXV813

Phase 2

Schizophrenia | Small molecule | Psychiatry |Novartis AG|Last Updated: Jun 26, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment142
FDA Designations
No designations recorded
Clinical trial landscape

GXV813 · 1 trial · 1 indication

Phase 2 1
NCT07467993Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With SchizophreniaSchizophrenia
RECRUITING142 Analytics
PHASE2RECRUITING
Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
Schizophrenia
NCT07467993142
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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 to 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

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 StatesBulgaria
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Competitive Landscape -Schizophrenia 37 trials
CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Novartis AG Sponsored ADRNVS1PHASE2GXV813
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
MapLight Therapeutics, Inc.MPLT1PHASE2ML-007C-MA
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Unity Health TorontoUBX1N/AUndisclosed
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Recent Changes (Last 90 Days)
MEDIUMJun 26, 2026NCT07467993primaryCompletionDate: changed
MEDIUMJun 26, 2026NCT07467993primaryCompletionDate: changed
LOWMay 26, 2026NCT07467993primaryCompletionDate: changed
LOWMay 24, 2026NCT07467993studyFirstPostDate: changed