Sulpiride

Overview

Sulpiride first appeared in published literature in 1967. Clinical studies show a greater effect on treating the negative symptoms of schizophrenia rather than positive symptoms at low doses, though the effects are more equal at higher doses. Sulpiride is not approved by the FDA, Health Canada, or the EMA; though it is approved in individual European countries.

Indication

Sulpiride is indicated for the treatment of acute and chronic schizophrenia.

Associated Conditions

Acute Schizophrenia
Chronic Schizophrenia
Constipation
Dyspepsia
Menière's Disease
Nausea
Psychosis
Schizophrenia
Vomiting

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Dopamine and Cognition	2023/06/01	NCT05884671	Not Applicable	Completed	Donders Centre for Cognitive Neuroimaging
The Role of Dopamine, Reward Learning and Prefrontal Activity in Expectation-induced Mood Enhancement	2022/01/26	NCT05208294	Not Applicable	Completed	Philipps University Marburg Medical Center
The Effect of Antiemetics on Bowel Preparation Before Colonoscopy	2020/10/12	NCT04583111	Phase 4	UNKNOWN	RenJi Hospital
Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric	2016/04/25	NCT02749747	Phase 3	Completed	Hospital de Clinicas de Porto Alegre
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients	2014/12/04	NCT02307396	Phase 4	Completed	Technical University of Munich
Interpersonal Psychotherapy for Treatment Resistant Depression	2013/07/11	NCT01896349	Not Applicable	UNKNOWN	Hospital de Clinicas de Porto Alegre
Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride After Oral Administration to Healthy Volunteers	2013/01/29	NCT01777685	Not Applicable	Completed	Damanhour University
Dopaminergic Modulation of Choroidal Blood Flow Changes During Dark/Light Transitions	2006/01/23	NCT00280501	Not Applicable	Completed	Medical University of Vienna

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DEVODIL 200 TABLET 200 mg	REMEDICA LTD	SIN09937P	TABLET	200 mg	8/7/1998

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TEPAZEPAN 50 MG/5 MG/5 MG CÁPSULAS DURAS	Kern Pharma S.L.	51519	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
DOGMATIL 50 mg/ml SOLUCION INYECTABLE	Neuraxpharm Spain S.L.	48557	SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
PSICOCEN 50 mg CAPSULAS	Especialidades Farmaceuticas Centrum S.A.	51836	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
SULPIRIDA KERN PHARMA 50 mg CAPSULAS EFG	Kern Pharma S.L.	73195	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
ANSIUM CAPSULAS DURAS	Neuraxpharm Spain S.L.	53295	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica. Psicótropos	Commercialized
DOGMATIL FUERTE 200 mg COMPRIMIDOS	Neuraxpharm Spain S.L.	48558	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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