drug
as of 2026-07-01Olanzapine
olanzapineolanzapine (15 mg)Oral olanzapineOlanzapine 10 MGOlanzapine & QuetiapineContinued Antipsychotic (Risperidone or Quetiapine or Olanzapine)full-dose olanzapineComparator: Olanzapine
MeSH D000077152UNII N7U69T4SZRRxCUI 153046, 153047, 153048, 200034, 212405, 261337FDA_ApplNo NDA020592SPL_set_id d5051fbc-846b-4946-82df-341fb1216341FDA_sponsor CHEPLAPHARMOrangeBook_Appl A076000, A076133, A076255, A076534, A076866, A077243, A077301, A077528
at a glance
small molecule · Atypical Antipsychotic [EPC]
US-approved (1996) as ZYPREXA Intramuscular
Developed by Eli Lilly and Company
Orange Book protection to 2041
190 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
FDA class
Atypical Antipsychotic [EPC]
Mechanism of action
12.1 Mechanism of Action The mechanism of action of olanzapine, in the listed indications is unclear. However, the efficacy of olanzapine in schizophrenia could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism.
Indications
Labeled
Bipolar maniaSchizophreniaBipolar depressionMajor depressive disorderAgitation
Investigational (via trials)
SchizophreniaSubstance-Related DisordersDiseaseSchizophrenic DisordersPsychological Well-BeingSubstance Use DisordersAggressionType 2 Diabetes MellitusDepressionIntellectual DisabilityAnxiety DisorderPsychosomatic DisordersSodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by AntipsychoticsDiabetes MellitusAcute AgitationMental Health
Patents & exclusivity
Orange Book
patent 11951111 · U-38862041-11-12
patent 123904742041-11-12
patent 117074662041-11-12
patent 10300054 · U-31402033-05-31
patent 8778960 · U-31362032-02-13
patent 91198482031-08-30
patent 11241425 · U-31372031-08-23
patent 10716785 · U-31362031-08-23
patent 9517235 · U-31392031-08-23
patent 12194035 · U-31412031-08-23
patent 11185541 · U-31402031-08-23
patent 11793805 · U-37342031-08-23
exclusivity NCE2026-05-28
Adverse-event signal
FAERS spontaneous · within-drug share
Weight Metabolic11.2%
top term: WEIGHT INCREASED
Eps Akathisia5.9%
top term: TREMOR
Sedation5.6%
top term: SOMNOLENCE
Gi4.6%
top term: NAUSEA
Mortality3.9%
top term: SUICIDE ATTEMPT
Hematologic2.8%
top term: NEUTROPENIA
Qt Cardiac2.5%
top term: TACHYCARDIA
Anticholinergic1.5%
top term: CONSTIPATION
Nms1.3%
top term: NEUROLEPTIC MALIGNANT SYNDROME
Orthostatic1.0%
top term: HYPOTENSION
Spontaneous reports — a signal of reporting share, not incidence.
Trials
190
Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
NCT07565428Phase 3Recruiting
"Extended" (Alternate Day) Antipsychotic Dosing
NCT04478838Phase 4Recruiting
Exercise and Olanzapine-samidorphan
NCT06740890Phase 4Recruiting
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
NCT05303064Phase 3Recruiting
Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
NCT05669742Phase 3Recruiting
A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
NCT06649214Phase 3Not Yet Recruiting
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
NCT03781115Phase 1Recruiting
An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia
NCT06315283Phase 1Completed
Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia
NCT06253546Phase 1Completed
Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis
NCT04529226Phase 2Unknown
Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
NCT06319170Phase 1Completed
Clinical Intervention on Cognitive Impairment of Schizophrenia With Metabolic Syndrome
NCT04518319Phase 2Suspended
A Four-week Clinical Trial Investigating Efficacy and Safety of Cannabidiol As a Treatment for Acutely Ill Schizophrenic Patients
NCT02088060Phase 2Terminated
A Study of Olanzapine in Patients With Acute Agitation
NCT05803642Phase 3Unknown
Characterizing Response to Antipsychotics in Schizophrenia
NCT06159322—Unknown
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia
NCT06107803Phase 1Completed
Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT)
NCT03510325Phase 3Completed
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
NCT03187769Phase 3Completed
Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder
NCT03857581Phase 4Unknown
Identification of Multi-modal Bio-markers for Early Diagnosis and Treatment Prediction in Schizophrenia Individuals
NCT03790085Early Phase 1Unknown
A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform
NCT02431702Phase 3Completed
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
NCT03557931Phase 2Completed
A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic
NCT03568500Phase 4Completed
Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy
NCT01609153Phase 4Completed
KOLs & investigators
12
Christoph U. Correll, MDKOL score 96
Stefan Leucht, ProfessorKOL score 87
Alan Breier, MDKOL score 23
Andrew Cutler, MDKOL score 19
Ariel Graff-Guerrero, MD, PhDKOL score 15
Stephen R. Marder, MDKOL score 14
Gary Remington, MD PhD FRCPCKOL score 12
René Kahn, Prof. Dr.KOL score 11
Jari Tiihonen, MD, PhDKOL score 10
Xiaoduo Fan, MD, MPH, MSKOL score 9
Jeffrey A. Lieberman, MDKOL score 9
Robert C. Smith, MD, PhDKOL score 9
Facts & assertions
28 sourced
Anda Generic Count
204
Boxed Warning
present
Dosing Frequency
once daily
Faers Share Anticholinergic
0.015
Faers Share Eps Akathisia
0.059
Faers Share Gi
0.046
Faers Share Hematologic
0.028
Faers Share Mortality
0.039
Faers Share Nms
0.013
Faers Share Orthostatic
0.01
Faers Share Qt Cardiac
0.025
Faers Share Sedation
0.056
Faers Share Weight Metabolic
0.112
Fda Pharm Class Epc
Atypical Antipsychotic [EPC]
Has Generic Competition
yes
Latest Exclusivity Expiry
2026-05-28
Latest Patent Expiry
2041-11-12
Latest Protection Date
2041-11-12
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of olanzapine, in the listed indications is unclear. However, the efficacy of olanzapine in schizophrenia could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism.
Originator Company
Cheplapharm
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
1996-09-30
relationships
The graph out of here
developer
company
trial
trial
indication
indication
indication
indication
indication
KOL
Christoph U. Correll, MD
personKOL score 96
Stefan Leucht, Professor
personKOL score 87
Alan Breier, MD
personKOL score 23
Andrew Cutler, MD
personKOL score 19