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Phase 2: Amisulpride
Amisulpride is a selective dopamine D2 and D3 receptor antagonist that blocks dopamine signaling in the brain to reduce psychotic symptoms and improve mood.
Amisulpride is a selective dopamine D2 and D3 receptor antagonist that blocks dopamine signaling in the brain to reduce psychotic symptoms and improve mood. Used for Schizophrenia, Psychotic disorders, Major depressive disorder with psychotic features.
At a glance
| Generic name | Phase 2: Amisulpride |
|---|---|
| Sponsor | Shanghai Mental Health Center |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Dopamine D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Amisulpride preferentially blocks dopamine receptors in the mesolimbic and mesocortical pathways at low doses, producing antipsychotic and antidepressant effects. At higher doses, it also blocks dopamine in the nigrostriatal pathway. Unlike typical antipsychotics, amisulpride has minimal affinity for other neurotransmitter receptors, resulting in a favorable side effect profile.
Approved indications
- Schizophrenia
- Psychotic disorders
- Major depressive disorder with psychotic features
Common side effects
- Elevated prolactin levels
- Amenorrhea
- Galactorrhea
- Sexual dysfunction
- Weight gain
- Insomnia
- Anxiety
Key clinical trials
- Enhancing Recovery in Early Schizophrenia (PHASE2)
- Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients (PHASE2, PHASE3)
- Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT) (PHASE3)
- A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV. (PHASE3)
- Optimizing and Individualizing the Pharmacological Treatment of First-episode Schizophrenic Patients
- Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy (PHASE2)
- Optimization of Treatment and Management of Schizophrenia in Europe (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: Amisulpride CI brief — competitive landscape report
- Phase 2: Amisulpride updates RSS · CI watch RSS
- Shanghai Mental Health Center portfolio CI