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GXV813

Phase 2

Schizophrenia | Small molecule | Psychiatry |Novartis AG|Last Updated: Jul 29, 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
SchizophreniaUnlock trial analytics

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 Sites16

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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Recent Changes (Last 90 Days)

LOWJul 29, 2026NCT07467993lastUpdatePostDate: changed
LOWJul 29, 2026NCT07467993lastUpdatePostDate: changed
MEDIUMJun 26, 2026NCT07467993primaryCompletionDate: changed
MEDIUMJun 26, 2026NCT07467993primaryCompletionDate: changed

Frequently asked questions about GXV813

What is GXV813 used for in schizophrenia?

GXV813 is an investigational small molecule being developed for the treatment of schizophrenia. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in hospitalized adults with schizophrenia to assess its safety, tolerability, and treatment response.

Who makes GXV813?

GXV813 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase 2 clinical trial of GXV813 in patients with schizophrenia.

What phase is GXV813 in?

GXV813 is in Phase 2 clinical development for schizophrenia. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is currently recruiting participants in the United States and Bulgaria.

What clinical trials is GXV813 in?

GXV813 is being studied in one active Phase 2 clinical trial with the identifier NCT07467993. This randomized, double-blind, placebo-controlled study is assessing the safety, tolerability, and treatment response of GXV813 in hospitalized adults with schizophrenia. The trial aims to enroll 142 participants aged 18 years and older.

How does GXV813 work?

GXV813 is a small molecule therapeutic being developed for schizophrenia. The specific molecular target or mechanism of action has not been disclosed in available information. The drug is currently being evaluated in a Phase 2 clinical trial to determine its safety and efficacy in treating schizophrenia.