Drug

Vigabatrin

Approved · EMA

Late-stage development

Also known as 4-Amino-5-hexenoic acid, GVG, Gamma vinyl GABA, Gamma vinyl gamma aminobutyric acid+10 more

4-Amino-5-hexenoic acid, GVG, Gamma vinyl GABA, Gamma vinyl gamma aminobutyric acid, Sabril, Vigadrone, Vigafyde, Vigpoder, Vinyl gamma-aminobutyric acid, gamma-Vinyl GABA, gamma-Vinyl-gamma-aminobutyric acid, Vigabatrina, Vigabatrine, Vigabatrinum.

RxNorm14851 ChEMBLCHEMBL89598UNIIGR120KRT6K

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Efficacy of Vigabatrin With High Dose Prednisolone Combination Therapy Versus Vigabatrin Alone for Infantile Spasm: a Randomized Trial

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Randomized, Placebo-controlled, Double-blind and Double-dummy Clinical Trial Comparing the Safety, Tolerability, and Efficacy of Vigabatrin and Rapamycin in a Preventive Treatment of Infants With Tuberous Sclerosis Complex

Clinical trial2026-03-01Primary completion · ClinicalTrials.gov

A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms

Clinical trial2025-12-01Withdrawn · ClinicalTrials.gov

The Effect of Vigabatrin on Insulin Sensitivity

Clinical trial2025-01-14Results posted · ClinicalTrials.gov

A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy

Clinical trial2021-08-01Suspended · ClinicalTrials.gov

Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study

Clinical trial2020-09-09Withdrawn · ClinicalTrials.gov

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile Spasms

Clinical trial2019-05-29Terminated · ClinicalTrials.gov

Prednisolone vs. Vigabatrin in the First-line Treatment of Infantile Spasms

Clinical trial2019-03-06Withdrawn · ClinicalTrials.gov

Approval: Kigabeq (EMA)

Regulatory2018-09-20EMA

Open Label Safety and Tolerability Trial of CPP-109 (Vigabatrin) in Adults With Treatment Refractory Tourette's Disorder

Clinical trial2018-01-19Results posted · ClinicalTrials.gov

A Prospective, Open-label Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)

Clinical trial2016-06-07Results posted · ClinicalTrials.gov

Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

Clinical trial2016-05-18Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Vigabatrin

Aliases & brands

4-Amino-5-hexenoic acidGVGGamma vinyl GABAGamma vinyl gamma aminobutyric acidSabrilVigadroneVigafydeVigpoderVinyl gamma-aminobutyric acidgamma-Vinyl GABAgamma-Vinyl-gamma-aminobutyric acidVigabatrinaVigabatrineVigabatrinum

RxNorm CUI

14851

ChEMBL ID

CHEMBL89598

UNII

GR120KRT6K

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2018-09-20

Latest approval

2018-09-20

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2018-09-20Approval

Approval: Kigabeq (EMA)

Indication: Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: Treatment in monotherapy of infantile spasms (West's syndrome). Treatment in… Show full indication

Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: Treatment in monotherapy of infantile spasms (West's syndrome). Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.