THERAPY DOSSIER · th-af9022a04f17

Vigabatrin

Drug · Irreversible inhibitor of gamma-aminobutyrate transaminase (GABA-T), raising CNS GABA concentrations. Direct interaction, disease efficacy true. Carries an FDA black box warning (permanent vision loss).

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Evidence & regulatory context

Mechanism: Irreversible inhibitor of gamma-aminobutyrate transaminase (GABA-T), raising CNS GABA concentrations. Direct interaction, disease efficacy true. Carries an FDA black box warning (permanent vision loss).
Target: CHEMBL2044 (4-aminobutyrate aminotransferase)
Injury models: Other
Reported indication: Not recorded
First approval: 2009
Development stage: Not recorded
ChEMBL record: CHEMBL89598 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Vigabatrin; Sabril; Vigafyde; Kigabeq; Gamma-vinyl GABA; Vinyl gamma-aminobutyric acid; CPP-109; MDL 71,754; RMI-71754
Note: Not recorded

Clinical trials 7

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT01266291 ↗PHASE4terminated

Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: Open Label Phase IV Safety and Tolerability Study

Complex Partial Seizures

Enrolment: 1 · Results not recorded

NCT03421496 ↗PHASE3terminated

Phase 3 Study of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile Spasms

Infantile Spasm

Enrolment: 2 · Results not recorded

NCT00611130 ↗PHASE2completed

Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

Cocaine Dependence

Enrolment: 186 · Results not recorded

NCT00373581 ↗PHASE2terminated

Effects of Vigabatrin on Cocaine Self-Administration

Cocaine Dependence

Enrolment: 1 · Results not recorded

NCT04468282 ↗PHASE1completed

Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and Sabril 500mg Granules for Oral Administration

Therapeutic Equivalency

Enrolment: 20 · Results not recorded

NCT02220114 ↗NAcompleted

Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy

Infantile Spasms

Enrolment: 38 · Results not recorded

NCT01073579 ↗Phase not recordedcompleted

Sabril Patient Registry

Infantile Spasms · Refractory Complex Partial Seizures in Adults

Enrolment: 9423 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 21872651 ↗2011Reported benefit

Early age conductive hearing loss causes audiogenic seizure and hyperacusis behavior.

RatOtherSprague-DawleyInjection or oral250 mg/kg (acute) or 60 mg/kg/dayAfter hearing loss developed

Model: Tympanic membrane perforation causing early-age conductive hearing loss

Vigabatrin suppressed audiogenic seizures induced by early-age conductive hearing loss.

Extraction: extract · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

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