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IM olanzapine
IM olanzapine is a Atypical antipsychotic Small molecule drug developed by National Taiwan University Hospital. It is currently in Phase 3 development for Acute agitation associated with schizophrenia or bipolar disorder, Schizophrenia, Bipolar I disorder. Also known as: zyprexa.
IM olanzapine is an intramuscular formulation of olanzapine, an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain.
IM olanzapine is an intramuscular formulation of olanzapine, an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain. Used for Acute agitation associated with schizophrenia or bipolar disorder, Schizophrenia, Bipolar I disorder.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | IM olanzapine |
|---|---|
| Also known as | zyprexa |
| Sponsor | National Taiwan University Hospital |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Serotonin 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Olanzapine antagonizes dopamine D2 receptors and serotonin 5-HT2A receptors, which reduces psychotic symptoms and stabilizes mood. The intramuscular formulation provides rapid onset and improved compliance compared to oral administration, making it suitable for acute agitation or when oral medication is not feasible.
Approved indications
- Acute agitation associated with schizophrenia or bipolar disorder
- Schizophrenia
- Bipolar I disorder
Common side effects
- Sedation
- Weight gain
- Hyperglycemia
- Hyperlipidemia
- Extrapyramidal symptoms
- Injection site reactions
Key clinical trials
- Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department (PHASE3)
- Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism (PHASE4)
- IM Olanzapine Versus Haloperidol or Midazolam (PHASE4)
- Olanzapine Versus Midazolam for Agitation
- Safety and Tolerability of INP105 (Olanzapine by I231 POD® Device) Nasal Spray in Healthy Volunteers - SNAP 101 (PHASE1)
- Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis (PHASE2)
- Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward (PHASE4)
- Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IM olanzapine CI brief — competitive landscape report
- IM olanzapine updates RSS · CI watch RSS
- National Taiwan University Hospital portfolio CI
Frequently asked questions about IM olanzapine
What is IM olanzapine?
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What is IM olanzapine used for?
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Is IM olanzapine also known as anything else?
What drug class is IM olanzapine in?
What development phase is IM olanzapine in?
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What does IM olanzapine target?
Related
- Drug class: All Atypical antipsychotic drugs
- Target: All drugs targeting Dopamine D2 receptor, Serotonin 5-HT2A receptor
- Manufacturer: National Taiwan University Hospital — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Acute agitation associated with schizophrenia or bipolar disorder
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Bipolar I disorder
- Also known as: zyprexa
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing