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Phase 2: Clozapine
Clozapine is an atypical antipsychotic that blocks dopamine D2 receptors and serotonin 5-HT2A receptors in the brain.
Clozapine is an atypical antipsychotic that blocks dopamine D2 receptors and serotonin 5-HT2A receptors in the brain. Used for Treatment-resistant schizophrenia, Reduction of suicidal behavior in schizophrenia or schizoaffective disorder.
At a glance
| Generic name | Phase 2: Clozapine |
|---|---|
| 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
Clozapine antagonizes dopamine D2 and serotonin 5-HT2A receptors, reducing psychotic symptoms. It also has activity at multiple other receptors including muscarinic, histaminergic, and adrenergic receptors, which contribute to both its therapeutic effects and side effect profile. Its unique pharmacology makes it effective in treatment-resistant schizophrenia where other antipsychotics have failed.
Approved indications
- Treatment-resistant schizophrenia
- Reduction of suicidal behavior in schizophrenia or schizoaffective disorder
Common side effects
- Agranulocytosis
- Sedation
- Weight gain
- Orthostatic hypotension
- Tachycardia
- Seizures
- Myocarditis
- Hypersalivation
Key clinical trials
- Maintenance ElectroConvulsive Therapy in Clozapine RESISTant Schizophrenia - the MECT-RESIST Trial (NA)
- Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT) (PHASE3)
- HDAC Inhibitor Augmentation to Clozapine (EARLY_PHASE1)
- Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18 (PHASE1)
- An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults (PHASE2, PHASE3)
- Optimization of Treatment and Management of Schizophrenia in Europe (PHASE4)
- Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia (PHASE4)
- Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis (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:
- Phase 2: Clozapine CI brief — competitive landscape report
- Phase 2: Clozapine updates RSS · CI watch RSS
- Shanghai Mental Health Center portfolio CI