CLINICAL TRIALS PROFILE FOR AMISULPRIDE

All Clinical Trials for amisulpride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00126009 ↗	SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients	Completed	Sanofi	Phase 2	2004-05-01	The primary objective is: - To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering from a manic episode according to DSM IV TR (American Psychiatric Association [APA] 2000) and treated for a 3-month period. The secondary objectives are: - To evaluate the clinical and biological safety of the association valproate-amisulpride to the association valproate-haloperidol; - To assess the patient status 3 weeks and 3 months after inclusion; and - To assess patient satisfaction at 3 months.
NCT00204061 ↗	Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis	Completed	Department of Psychiatry University of Bonn	Phase 4	2001-01-01	The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.
NCT00204061 ↗	Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis	Completed	German Federal Ministry of Education and Research	Phase 4	2001-01-01	The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.
NCT00204061 ↗	Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis	Completed	German Research Network On Schizophrenia	Phase 4	2001-01-01	The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.

Clinical Trial Conditions for amisulpride

Condition Name

Condition Name for amisulpride
Intervention	Trials
Schizophrenia	36
Schizoaffective Disorder	4
PONV	4
Schizophreniform Disorder	4

Condition MeSH

Condition MeSH for amisulpride
Intervention	Trials
Schizophrenia	37
Psychotic Disorders	11
Postoperative Nausea and Vomiting	6
Disease	6

Clinical Trial Locations for amisulpride

Trials by Country

Trials by Country for amisulpride
Location	Trials
Germany	25
United States	20
Spain	11
China	8
United Kingdom	8

Trials by US State

Trials by US State for amisulpride
Location	Trials
Ohio	4
Florida	4
North Carolina	3
Massachusetts	3
California	2

Clinical Trial Progress for amisulpride

Clinical Trial Phase

Clinical Trial Phase for amisulpride
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	10
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for amisulpride
Clinical Trial Phase	Trials
Completed	41
Recruiting	7
Not yet recruiting	6

Clinical Trial Sponsors for amisulpride

Sponsor Name

Sponsor Name for amisulpride
Sponsor	Trials
Acacia Pharma Ltd	8
Sanofi	8
Shanghai Mental Health Center	5

Sponsor Type

Sponsor Type for amisulpride
Sponsor	Trials
Other	91
Industry	28
NIH	2

Amisulpride: Clinical Trials Update, Market Analysis, and Projections

Introduction to Amisulpride

Amisulpride is an atypical antipsychotic medication primarily used in the treatment of schizophrenia and other psychotic disorders. It has been studied extensively for its efficacy, safety, and pharmacokinetics, making it a significant player in the psychiatric medication market.

Clinical Trials Update

Efficacy in Schizophrenia

A prospective, multicenter, open-label study involving 37 patients with schizophrenia who were switched to amisulpride due to suboptimal efficacy or tolerability with their current antipsychotics showed promising results. The study found that 56.8% of patients achieved clinical benefit as measured by the Clinical Global Impressions-Clinical Benefit (CGI-CB) score at week 6. Significant improvements were observed in CGI-CB and CGI-Severity (CGI-S) scores, as well as in Subjective Satisfaction Scores (SSS)[1].

Augmentation Therapy in Treatment-Resistant Schizophrenia

A 12-week randomized, double-blind, placebo-controlled trial explored the efficacy of amisulpride as an augmentation therapy to clozapine in patients with clozapine-resistant treatment-refractory schizophrenia (CTRS). The study demonstrated that amisulpride augmentation significantly improved psychiatric symptoms and cognitive performance compared to the placebo group. The amisulpride group showed lower Positive and Negative Syndrome Scale (PANSS) scores and improved language scores on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)[4].

Pharmacokinetics and Dosing

Impact of Renal Function

A population pharmacokinetics study in Chinese patients highlighted the importance of renal function in amisulpride dosing. The study used plasma concentrations from 921 patients to model the pharmacokinetics of amisulpride and found that renal clearance significantly influences plasma concentrations. The results suggested that dosing should be adjusted based on renal function to avoid exceeding therapeutic windows, especially in older patients, females, and those taking amisulpride with other medications like lithium[3].

Dosing Regimens

The same study simulated amisulpride plasma concentrations for various dosing regimens, including 100 mg to 600 mg twice daily, and considered different renal profiles. This helps clinicians in tailoring the dosage to individual patient needs, ensuring optimal therapeutic effects while minimizing side effects[3].

Market Analysis

Market Size and Growth

The global amisulpride market is experiencing substantial growth, driven by increasing demand for effective antipsychotic medications. Market research reports indicate that the market is expected to grow significantly over the forecast period from 2024 to 2031, with key segments including hospital pharmacies, retail pharmacies, and online pharmacies[2][5].

Key Players

The main players in the amisulpride market include Qilu Pharma, Sanofi, and Vexxa Lifescience. These companies are driving the market through their extensive distribution networks and continuous research and development efforts[2][5].

Product Segmentation

The amisulpride market is segmented by product type, including 50mg, 200mg, and 400mg tablets. This segmentation allows for tailored treatment options based on patient needs and clinical guidelines[2][5].

Geographical Distribution

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to show significant growth due to increasing healthcare expenditure and a large patient population[2][5].

Market Projections

Forecast Period

The forecast period from 2024 to 2031 is expected to see a substantial increase in the value of the amisulpride market, measured in USD million. The historical period from 2021 to 2023 has already shown promising growth, indicating a strong potential for future expansion[2].

Revenue and Volume Forecast

Market reports provide detailed revenue and volume forecasts, highlighting the expected growth in both value and volume terms. This growth is attributed to the increasing prevalence of schizophrenia, improved diagnostic rates, and the efficacy of amisulpride in treating psychiatric disorders[5].

Conclusion

Amisulpride is a critical medication in the treatment of schizophrenia, with robust clinical trial data supporting its efficacy and safety. The market for amisulpride is growing rapidly, driven by increasing demand and the presence of key players like Qilu Pharma, Sanofi, and Vexxa Lifescience. Understanding the pharmacokinetics and adjusting dosing based on renal function are crucial for optimizing treatment outcomes.

Key Takeaways

• Clinical Efficacy: Amisulpride has shown significant clinical benefit in patients with schizophrenia, especially those who have not responded well to other antipsychotics.
• Pharmacokinetics: Renal function plays a critical role in amisulpride dosing, and adjustments should be made to avoid exceeding therapeutic windows.
• Market Growth: The global amisulpride market is expected to grow substantially from 2024 to 2031, driven by increasing demand and key market players.
• Geographical Segmentation: The Asia-Pacific region is expected to show significant growth due to increasing healthcare expenditure and a large patient population.
• Product Segmentation: The market is segmented by product type, including 50mg, 200mg, and 400mg tablets, allowing for tailored treatment options.

FAQs

What is amisulpride used for?

Amisulpride is primarily used in the treatment of schizophrenia and other psychotic disorders.

How does renal function affect amisulpride dosing?

Renal function significantly influences amisulpride plasma concentrations, and dosing should be adjusted based on renal function to avoid exceeding therapeutic windows[3].

What are the key segments in the amisulpride market?

The key segments include hospital pharmacies, retail pharmacies, and online pharmacies, as well as product types such as 50mg, 200mg, and 400mg tablets[2][5].

Who are the main players in the amisulpride market?

The main players include Qilu Pharma, Sanofi, and Vexxa Lifescience[2][5].

What is the expected growth of the amisulpride market?

The market is expected to grow substantially from 2024 to 2031, with significant increases in both value and volume terms[2][5].

Sources

1. Amisulpride Switching in Schizophrenic Patients Who Showed Suboptimal Efficacy or Tolerability with Their Current Antipsychotics. Clinical Psychopharmacology and Neuroscience, 2016.
2. Global Amisulpride (CAS 71675-85-9) Market Size And Forecast. Market Research Intellect, 2024.
3. Population pharmacokinetics of Amisulpride in Chinese patients with schizophrenia with external validation: the impact of renal function. Frontiers in Pharmacology, 2023.
4. Amisulpride Augmentation Therapy in Clozapine-Resistant Treatment-Refractory Schizophrenia: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial. PubMed, 2022.
5. Global Amisulpride Market Research Report 2024. Valuates Reports, 2024.