Recent Updates
Recently added Catalysts

Olanzapine Immediate Release

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Clinical trial landscape

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 Disorder
NCT06319170106
Unlock 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)
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria