Sertindole

Overview

Sertindole, a neuroleptic, is one of the newer antipsychotic medications available. Serdolect is developed by the Danish pharmaceutical company H. Lundbeck. It is a phenylindole derivative used in the treatment of schizophrenia. It was first marketed in 1996 in several European countries before being withdrawn two years later because of numerous cardiac adverse effects. It has once again been approved and should soon be available on the French and Australian market.

Indication

Used in the treatment of schizophrenia.

Associated Conditions

Schizophrenia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
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
The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia	2013/12/27	NCT02021201	Phase 4	Terminated	Birte Glenthoj
An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)	2011/12/23	NCT01498770	N/A	Completed	Organon and Co
Comparing the Effects of Sertindole and Olanzapine on Cognition (SEROLA)	2009/04/22	NCT00885690	Not Applicable	Terminated	University of Aarhus
Sertindole in Asian Patients With Schizophrenia	2009/03/18	NCT00864045	Phase 3	Completed	H. Lundbeck A/S
Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use	2009/03/06	NCT00856583	Phase 3	Completed	H. Lundbeck A/S
Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia	2008/10/01	NCT00763438	Phase 4	Completed	H. Lundbeck A/S
Exploratory Cognition Study of Sertindole in Patients With Schizophrenia	2008/09/25	NCT00759421	Phase 3	Completed	H. Lundbeck A/S
Study on Metabolic Parameters of Sertindole in Patients With Schizophrenia	2008/09/25	NCT00759460	Phase 3	Completed	H. Lundbeck A/S

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
No HSA approvals found for this drug.

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
SERDOLECT 4 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	H. Lundbeck A/S	61582	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
SERDOLECT 12 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	H. Lundbeck A/S	61584	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
SERDOLECT 16 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	H. Lundbeck A/S	61585	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
SERDOLECT 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	H. Lundbeck A/S	61586	COMPRIMIDO RECUBIERTO CON PELÍCULA	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.

AI-Powered Research

Premium Access