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Olanzapine Immediate Release

Phase 1

Schizophrenia, Schizoaffective Disorder | Small molecule | Psychiatry |Teva Pharmaceutical Industries Limited|Trials Updated: Jan 26, 2026

Olanzapine Immediate Release development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2024

Olanzapine Immediate Release target and mechanism

Molecular targetDRD2, DRD3, DRD4, HTR2C, HTR2A
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL715

Also known as ZYPREXA

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Olanzapine Immediate Release clinical trials

Olanzapine Immediate Release · 1 trial · 1 indication

Phase 1 1
NCT06319170Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective DisorderSchizophrenia, Schizoaffective Disorder
COMPLETED106 Analytics
PHASE1COMPLETED
Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
Schizophrenia, Schizoaffective DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)
Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)
Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)
Randomization Day 1 to 84 days after randomization

Secondary Endpoints

Number of Participants With at Least 1 Treatment-emergent Adverse Event (TEAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
Randomization Day 1 through Randomization Day 29
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
Randomization Day 1 through Randomization Day 29
Cmax of ZYPREXA (Immediate-release Formulation)
Up to 24 hours after administration of ZYPREXA (Day 4)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Olanzapine (Fast-D) 425mgEXPERIMENTALSingle-dose injection
Olanzapine (To-be-marketed) 425mgEXPERIMENTALSingle-dose injection
Olanzapine (Slow-C) 425mgEXPERIMENTALSingle-dose injection
ZYPREXA 5mgEXPERIMENTALSingle-dose injection

Interventions

NameTypeDescription
Olanzapine Extended ReleaseDRUGPowder and vehicle for injectable suspension
Olanzapine Immediate ReleaseDRUGIntraMuscular Injection
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Body weight \>50 kg and body mass index (BMI) within the range 18.5 to 38.0 kg/m2, inclusive, at the time of screening * Agree to maintain current smoking or nonsmoking status at the time informed consent is obtained and throughout the trial until completion of the end of trea...

Countries:United States
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Frequently asked questions about Olanzapine Immediate Release

What is Olanzapine Immediate Release used for?

Olanzapine Immediate Release is being developed for the treatment of schizophrenia and schizoaffective disorder. It is an immediate-release formulation of olanzapine, an antipsychotic small molecule. Teva Pharmaceutical Industries Limited is the developer. The program is in Phase 1 clinical development.

What does Olanzapine Immediate Release target?

Olanzapine Immediate Release targets dopamine receptors DRD2, DRD3, and DRD4, and serotonin receptors HTR2A and HTR2C. It acts as an antagonist at these receptors. This receptor binding profile is characteristic of atypical antipsychotic activity relevant to schizophrenia and schizoaffective disorder.

Who makes Olanzapine Immediate Release?

Teva Pharmaceutical Industries Limited is developing Olanzapine Immediate Release. Teva trades on the New York Stock Exchange under the ticker TEVA. The company is responsible for the clinical development of this immediate-release olanzapine formulation for schizophrenia and schizoaffective disorder.

What phase is Olanzapine Immediate Release in?

Olanzapine Immediate Release is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program includes one completed Phase 1 trial with 106 participants. No active trials are currently listed for this asset.

What clinical trials is Olanzapine Immediate Release in?

Olanzapine Immediate Release has been studied in one completed Phase 1 trial, NCT06319170. The trial was an open-label study characterizing the pharmacokinetics of three subcutaneous olanzapine extended-release formulations in participants with schizophrenia or schizoaffective disorder. It enrolled 106 participants in the United States and was controlled and randomized.