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NBI-1117570

Phase 2

Schizophrenia | Small molecule | Psychiatry |Neurocrine Biosciences, Inc.|Last Updated: Jul 22, 2026

Target and mechanism

Molecular targetmuscarinic receptors
Target classReceptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

NBI-1117570 · 1 trial · 1 indication

Phase 2 1
NCT07288333Evaluation of NBI-1117570 in Inpatient Adults With SchizophreniaSchizophrenia
RECRUITING120 Analytics
PHASE2RECRUITING
Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 35
Day 35

Secondary Endpoints

Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Day 1 up to Day 49
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NBI-1117570: Lower-doseEXPERIMENTALParticipants will receive a lower-dose of NBI-1117570.
NBI-1117570: Higher-doseEXPERIMENTALParticipants will receive a higher-dose of NBI-1117570.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to NBI-1117570.

Interventions

NameTypeDescription
NBI-1117570DRUGOral administration
PlaceboDRUGOral administration
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: * 18 to 55 years of age * Primary diagnosis of schizophrenia ≥1 year before screening. * Participant is experiencing an acute exacerbation or relapse of symptoms with onset less than 2 months before screening and currently requires hospitalization. * Participant must have ha...

Countries:BulgariaRomaniaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 22, 2026NCT07288333lastUpdatePostDate: changed
LOWJul 22, 2026NCT07288333lastUpdatePostDate: changed

Frequently asked questions about NBI-1117570

What is NBI-1117570 used for in schizophrenia?

NBI-1117570 is an investigational small molecule being developed for the treatment of schizophrenia. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in inpatient adults with schizophrenia to assess its safety and efficacy.

What does NBI-1117570 target?

NBI-1117570 targets muscarinic receptors, which are a class of receptors involved in various neurological and psychiatric functions. By acting on these receptors, the drug aims to modulate signaling pathways relevant to schizophrenia. This mechanism is being investigated in clinical trials for its potential therapeutic effects.

Who makes NBI-1117570?

NBI-1117570 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol NBIX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with schizophrenia.

What phase is NBI-1117570 in?

NBI-1117570 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 2 trial is designed to assess the drug's efficacy and safety in adults with schizophrenia.

What clinical trials is NBI-1117570 in?

NBI-1117570 is being studied in a Phase 2 clinical trial with the identifier NCT07288333, titled "Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia." This randomized, double-blind, placebo-controlled trial is recruiting participants in Bulgaria, Romania, and the United Kingdom, with an enrollment target of 120 adults aged 18 years and older.

Is NBI-1117570 the same as any other drug?

NBI-1117570 is a unique investigational compound and is not known to be the same as any other marketed drug. It is being developed specifically by Neurocrine Biosciences for schizophrenia and is currently in Phase 2 trials. No alternative names have been associated with this drug in the available information.