Overview
Vigabatrin is an analog of gamma-aminobutyric acid (GABA), the main inhibitory neurotransmitter in the central nervous system, used in the treatment of refractory seizures and infantile spasms. It irreversibly inhibits the enzyme responsible for GABA metabolism, thereby increasing levels of circulating GABA. Although administered as a racemic mixture, only the S(+) enantiomer is pharmacologically active. It was first introduced as an antiepileptic agent in the United Kingdom in 1989 and was used extensively until 1997, when an association with vision loss became apparent. Its use is now generally reserved for patients who have failed alternative therapies, and its US approval by the FDA in 2009 mandated the creation of a drug registry to monitor patients for visual deficits.
Indication
Vigabatrin is indicated as adjunctive therapy in the treatment of refractory complex partial seizures in patients 2 years of age and older who have had inadequate responses to multiple previous treatments (i.e. not to be used for first-line therapy). It is also indicated as monotherapy in the treatment of infantile spasms in patients between 1 month and 2 years of age for whom the potential benefits outweigh the risk of vision loss.
Associated Conditions
- Infantile Spasms (IS)
- Refractory Complex partial seizures
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/08/03 | Phase 2 | Recruiting | Katarzyna Kotulska | ||
2021/02/26 | Phase 2 | Completed | |||
2020/03/25 | Phase 2 | Completed | |||
2020/03/10 | Not Applicable | Recruiting | Kullasate Sakpichaisakul | ||
2019/08/20 | Phase 2 | UNKNOWN | |||
2018/02/05 | Phase 3 | Terminated | |||
2017/11/20 | Phase 3 | Suspended | |||
2017/06/22 | N/A | Recruiting | |||
2016/12/26 | Not Applicable | Withdrawn | |||
2016/07/29 | Phase 2 | Completed | Martina Bebin |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Dr. Reddys Laboratories Inc., | 43598-697 | ORAL | 50 mg in 1 mL | 11/11/2021 | |
| Lupin Pharmaceuticals, Inc. | 68180-521 | ORAL | 500 mg in 1 1 | 12/1/2022 | |
| Amneal Pharmaceuticals NY LLC | 69238-1425 | ORAL | 500 mg in 1 1 | 12/30/2023 | |
| Actavis Pharma, Inc. | 0591-3851 | ORAL | 500 mg in 1 1 | 3/31/2022 | |
| Upsher-Smith Laboratories, LLC | 0245-0556 | ORAL | 50 mg in 1 mL | 9/24/2020 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1287 | ORAL | 500 mg in 1 1 | 3/21/2024 | |
| Amneal Pharmaceuticals NY LLC | 60219-1424 | ORAL | 500 mg in 1 1 | 4/27/2023 | |
| Actavis Pharma, Inc. | 0591-3955 | ORAL | 50 mg in 1 mL | 11/30/2022 | |
| Upsher-Smith Laboratories, LLC | 0245-6001 | ORAL | 500 mg in 1 1 | 3/31/2023 | |
| Novadoz Pharmaceuticals LLC | 72205-093 | ORAL | 50 mg in 1 mL | 7/21/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/20/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SABRIL TABLET 500 mg | SIN07955P | TABLET, FILM COATED | 500 mg | 12/9/1994 |
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 |
|---|---|---|---|---|---|
| SABRIL vigabatrin 0.5g powder oral sachetl | 52985 | Medicine | A | 7/17/1995 | |
| SABRIL vigabatrin 500mg tablet blister pack | 150021 | Medicine | A | 5/12/2008 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SABRIL | 02065819 | Tablet - Oral | 500 MG | 12/31/1994 | |
| SABRIL PWR 2G/SACHET | aventis pharma inc | 02068001 | Powder - Oral | 2 G / PCK | N/A |
| SABRIL PWR 1G/SACHET | aventis pharma inc | 02068028 | Powder - Oral | 1 G / PCK | N/A |
| SABRIL | 02068036 | Powder For Solution - Oral | 500 MG / SACHET | 8/20/1997 | |
| SABRIL PWR 3G/SACHET | aventis pharma inc | 02067994 | Powder - Oral | 3 G / PCK | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| KIGABEQ 100 MG COMPRIMIDOS SOLUBLES | 1181302001 | COMPRIMIDO SOLUBLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| SABRILEX 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Sanofi Aventis S.A. | 59361 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| KIGABEQ 500 MG COMPRIMIDOS SOLUBLES | 1181302002 | COMPRIMIDO SOLUBLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| VIGZIP 100 MG/ML SOLUCION ORAL | Ria Generics Limited | 89567 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| SABRILEX 500 mg GRANULADO PARA SOLUCION ORAL | Sanofi Aventis S.A. | 59809 | POLVO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | 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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