Tiagabine

Overview

Tiagabine is an anti-convulsive medication. It is also used in the treatment for panic disorder as are a few other anticonvulsants. Though the exact mechanism by which tiagabine exerts its effect on the human body is unknown, it does appear to operate as a selective GABA reuptake inhibitor.

Indication

For the treatment of partial seizures

Associated Conditions

Partial-Onset Seizures

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Population Pharmacokinetics of Antiepileptic in Pediatrics	2017/06/22	NCT03196466	N/A	Recruiting	Assistance Publique - Hôpitaux de Paris
Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea	2015/03/13	NCT02387710	Phase 2	Completed	Brigham and Women's Hospital
Characterization of [11C]Flumazenil to Image GABA Transmission in Healthy Adult Subjects and Subjects With Alcohol Dependence	2013/07/22	NCT01904487	Phase 1	Completed	Rajesh Narendran
A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder	2005/10/12	NCT00236067	Phase 3	Completed	Cephalon
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder	2005/10/12	NCT00236054	Phase 3	Completed	Cephalon
A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder	2005/10/12	NCT00236015	Phase 3	Completed	Cephalon
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder	2005/10/06	NCT00233675	Phase 3	Completed	Cephalon
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.	2005/09/22	NCT00214994	Phase 3	Completed	Cephalon
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder	2005/09/21	NCT00208741	Phase 4	Completed	Emory University
Treating Schizophrenia by Correcting Abnormal Brain Development	2005/09/16	NCT00179465	Phase 3	Active, not recruiting	Beth Israel Deaconess Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
GABITRIL	Cephalon, LLC	63459-404	ORAL	4 mg in 1 1	7/19/2023
Tiagabine Hydrochloride	Novadoz Pharmaceuticals LLC	72205-086	ORAL	12 mg in 1 1	3/1/2021
Tiagabine Hydrochloride	Novadoz Pharmaceuticals LLC	72205-085	ORAL	4 mg in 1 1	3/1/2021
Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	0093-5031	ORAL	4 mg in 1 1	9/30/2021
Tiagabine Hydrochloride	Novadoz Pharmaceuticals LLC	72205-087	ORAL	16 mg in 1 1	3/1/2021
GABITRIL	Cephalon, LLC	63459-416	ORAL	16 mg in 1 1	7/19/2023
Tiagabine Hydrochloride	Teva Pharmaceuticals USA, Inc.	0093-8076	ORAL	16 mg in 1 1	9/30/2021
Tiagabine Hydrochloride	Amneal Pharmaceuticals NY LLC	69238-1106	ORAL	12 mg in 1 1	12/30/2023
GABITRIL	STAT RX USA LLC	16590-832	ORAL	12 mg in 1 1	8/11/2011
Tiagabine Hydrochloride	Novadoz Pharmaceuticals LLC	72205-084	ORAL	2 mg in 1 1	3/1/2021

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
GABITRIL tiagabine (as hydrochloride monohydrate) 15mg tablet bottle	120273	Teva Pharma Australia Pty Ltd	Medicine	A	9/14/2006
GABITRIL tiagabine (as hydrochloride monohydrate) 5mg tablet bottle	120271	Teva Pharma Australia Pty Ltd	Medicine	A	9/14/2006
GABITRIL tiagabine (as hydrochloride monohydrate) 10mg tablet bottle	120272	Teva Pharma Australia Pty Ltd	Medicine	A	9/14/2006

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
GABITRIL 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Teva B.V.	61607	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
GABITRIL 15 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Teva B.V.	61608	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
GABITRIL 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Teva B.V.	61606	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