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Phase 1: Olanzapine
Olanzapine is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain.
Olanzapine is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain. Used for Schizophrenia, Bipolar I disorder (acute mania and maintenance treatment), Treatment-resistant depression (as adjunctive therapy).
At a glance
| Generic name | Phase 1: Olanzapine |
|---|---|
| Sponsor | Shanghai Mental Health Center |
| 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 in the mesolimbic and mesocortical pathways, reducing psychotic symptoms, while also blocking serotonin 5-HT2A receptors which may enhance antipsychotic efficacy and reduce extrapyramidal side effects. It also has activity at multiple other receptors including muscarinic, histamine H1, and alpha-adrenergic receptors, contributing to its side effect profile.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute mania and maintenance treatment)
- Treatment-resistant depression (as adjunctive therapy)
Common side effects
- Weight gain
- Sedation
- Metabolic syndrome / hyperglycemia
- Hyperlipidemia
- Akathisia
- Orthostatic hypotension
- Prolactin elevation
Key clinical trials
- A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia (PHASE3)
- Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile (PHASE2)
- Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (PHASE3)
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) (PHASE1, PHASE2)
- Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma (PHASE1)
- Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia (PHASE1)
- Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients (PHASE3)
- Olanzapine and 5-HT3 With or Without Dexamethasone to Prevent CINV (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |