Wednesday, July 8, 2026

Drug profile · INN

vigabatrin

vigabatrin (SABRIL) is a gamma-amino-n-butyrate transaminase inhibitor. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Nervous system (N03) N03AG04
US status approved
Patents linked 3
Pipeline programs 3
News articles 0
Drug details — vigabatrin
US status
approved
Class
Nervous system (N03)
Route
ORAL
Patents
3
Programs
3
Data quality
0.89

Quick answer

vigabatrin (SABRIL) is a gamma-amino-n-butyrate transaminase inhibitor. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN vigabatrin
Brand SABRIL
Mechanism Gamma-amino-N-butyrate transaminase inhibitor
Target 4-aminobutyrate aminotransferase, mitochondrial
Therapeutic class Nervous system (N03)
Route ORAL
Formulation SOLUTION
ATC code N03AG04

Mechanism of action

Gamma-amino-N-butyrate transaminase inhibitor

Primary target: 4-aminobutyrate aminotransferase, mitochondrial

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Vigabatrin Phase 3 · BRIGHT MINDS BIOSCIENCES · Cocaine Addiction
  2. CPP-109 vigabatrin Phase 2 · CATALYST PHARMACEUTICALS · Methamphetamine Dependence
  3. vigabatrin Phase 2 · CATALYST PHARMACEUTICALS · Cocaine Dependence

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 12285397

    Use of (s)-3-amino-4-(difluoromethylenyl) cyclopent-1-ene-1-carboxylic acid and related compounds, (1S,3S)-3-amino-4-(difluoromethylidene) cyclopentane-1-carboxylic acid and vigabatrin in the treatment of developmental disorders

    Expires Mon Apr 24 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11660277

    Use of (S)-3-amino-4-(difluoromethylenyl) cyclopent-1-ene-1-carboxylic acid and related compounds, (1S,3S)-3-amino-4-(difluoromethylidene) cyclopentane-1-carboxylic acid and vigabatrin in the treatment of developmental disorders

    Expires Mon May 25 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10813899

    Use of (s)-3-amino-4-(difluoromethylenyl) cyclopent-1-ene-l-carboxylic acid and related compounds, (1s,3S)-3-amino-4-(difluoromethylidene) cyclopentane-1-carboxylic acid and vigabatrin in the treatment of developmental disorders

    Expires Mon Oct 22 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is vigabatrin?

vigabatrin (SABRIL) is a gamma-amino-n-butyrate transaminase inhibitor. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for vigabatrin?

SABRIL is a marketed brand name for vigabatrin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of vigabatrin?

vigabatrin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.