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placebo with Clozapine
Clozapine is an atypical antipsychotic that blocks dopamine and serotonin receptors in the brain to reduce psychotic symptoms.
Placebo with Clozapine, marketed by the Shanghai Mental Health Center, holds a niche position in the psychiatric treatment landscape. The key composition patent expires in 2028, providing a period of exclusivity that supports current market presence. The primary risk is the lack of clear primary indication and revenue data, which may limit strategic planning and market expansion efforts.
At a glance
| Generic name | placebo with 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 | FDA-approved |
Mechanism of action
Clozapine antagonizes dopamine D2 receptors and serotonin 5-HT2A receptors, reducing hyperactivity in mesolimbic and mesocortical pathways associated with psychosis. It also has activity at multiple other receptors including muscarinic, histaminergic, and adrenergic receptors, which contribute to its therapeutic and adverse effects. The combination with placebo in this context likely refers to a clinical trial design comparing clozapine efficacy against placebo control.
Approved indications
- Schizophrenia, particularly treatment-resistant cases
- Schizoaffective disorder
- Reduction of suicidal behavior in schizophrenia
Common side effects
- Agranulocytosis
- Sedation
- Weight gain
- Orthostatic hypotension
- Tachycardia
- Seizures
- Myocarditis
- Hypersalivation
Key clinical trials
- Stratification and Treatment in Early Psychosis Study -ASSIST (PHASE3)
- Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia (PHASE4)
- Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia (PHASE4)
- Effects of Buspirone Combined With Clozapine (EARLY_PHASE1)
- Does GLP-1RA Prevent Deterioration of Metabolic State in Prediabetic and Diabetic Patients Treated With Antipsychotic Medication? (PHASE4)
- Switching Antipsychotics: Abrupt Discontinuation Versus Overlap (PHASE4)
- Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy (PHASE4)
- 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)
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:
- placebo with Clozapine CI brief — competitive landscape report
- placebo with Clozapine updates RSS · CI watch RSS
- Shanghai Mental Health Center portfolio CI