Drugs / Vigabatrin
Vigabatrin
also known as
Sabril · VGB · 5-hexenoic acid, 4-amino- · CPP-109 · gamma vinyl-GABA · gamma vinyl-gamma-amino butyric acid · GVG · Kigabeq · +6 more
Small molecule targets ABAT via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VIGAFYDE | — | 2025-09-03 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | SABRIL | — | 2013-10-26 – 2020-01-24 | fda.gov ↗ |
| Approved | EU (EMA) | Kigabeq | — | 2018-09-20 | europa.eu ↗ |
| Approved | US (FDA) | SABRIL | — | 2009-08-21 | fda.gov ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00626834 | Feb 2008 → Oct 2010 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01585207 | Jul 2012 → Mar 2015 | Tourette syndrome | Barbara J. Coffey | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT04772547 | Sep 2021 → Jun 2023 | epilepsy | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT04321395 | Aug 2021 → Dec 2023 | metabolic dysfunction-associated steatotic liver disease, obesity disorder | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT02849457 | Dec 2016 → Apr 2023 | tuberous sclerosis | Martina Bebin | Completed | No outcome recorded |
| Phase 2 | NCT01335867 | Apr 2011 → Apr 2013 | alcohol dependence, cocaine dependence | University of Pennsylvania | Terminated | No outcome recorded |
| Phase 2 | NCT00611130 | Jan 2008 → May 2009 | cocaine dependence | Catalyst Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00373581 | Apr → Dec 2006 | cocaine dependence | New York State Psychiatric Institute | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04987463 | May 2021 → Mar 2026 | tuberous sclerosis | Katarzyna Kotulska | Unknown | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT01413711 | Jun 2012 → Sep 2013 | infantile spasms | Lundbeck LLC | Withdrawn | No outcome recorded |
| Phase 4 | NCT01278173 | Dec 2010 → May 2015 | complex partial epilepsy | Lundbeck LLC | Completed | No outcome recorded |
| Phase 4 | NCT01266291 | Aug 2010 → Feb 2013 | complex partial epilepsy | University of Pennsylvania | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03003143 | Nov 2016 → Sep 2020 | autoimmune disease | Seoul National University Hospital | Withdrawn | No outcome recorded |
| — | NCT02220114 | May 2014 → Dec 2016 | infantile spasms | Orphelia Pharma | Completed | No outcome recorded |
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT04062890 Comparator | Apr → Dec 2030 | glucose intolerance, hyperinsulinism, hypertensive disorder | University of Arizona | Withdrawn | No outcome recorded |
| Phase 2 | NCT00730522 Comparator | Jul 2008 → Jun 2009 | methamphetamine dependence | Catalyst Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00527683 Comparator | Apr → Nov 2007 | cocaine dependence | NYU Langone Health | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01281202 Comparator | Jan 2011 → Oct 2012 | cocaine dependence | Catalyst Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05128344 Comparator | Apr 2023 → Jun 2025 | infantile spasms | Amzell | Withdrawn | No outcome recorded |
| Phase 3 | NCT03421496 Background | Sep 2018 → May 2019 | infantile spasms | Radius Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT03347526 Comparator | Apr 2018 → Jun 2021 | infantile spasms | University of Colorado, Denver | Suspended | No outcome recorded |
| Phase 3 | NCT02299115 Comparator | Sep 2017 → Mar 2019 | infantile spasms | The Hospital for Sick Children | Withdrawn | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02205931 Comparator | Jan 2015 → Jun 2018 | epilepsy | University College, London | Unknown | No outcome recorded |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03636958 Background | Feb 2021 → Jul 2025 | epilepsy | Assistance Publique Hopitaux De Marseille | Withdrawn | No outcome recorded |
| — | NCT04302116 Comparator | May 2020 → Jun 2026 overdue | infantile spasms | Kullasate Sakpichaisakul | Recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2019-02-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces U.S. Launch of a Generic Version of Sabril® (Vigabatrin) tevapharm.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vigabatrin | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗24“Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗ “Vigabatrin” NCT02205931 ↗ |
| Known as | 5-hexenoic acid, 4-amino- | ChEMBL registry synonym — accepted as the source's own label CHEMBL89598 ↗ |
| Known as | CPP-109 | “CPP-109 vigabatrin” NCT00730522 ↗ |
| Known as | gamma vinyl-GABA | “the anticonvulsant, gamma vinyl-GABA (GVG; vigabatrin), decreases relapse to cocaine use” NCT00373581 ↗ |
| Known as | gamma vinyl-gamma-amino butyric acid | “oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions” NCT00626834 ↗ |
| Known as | GVG | “the anticonvulsant, gamma vinyl-GABA (GVG; vigabatrin), decreases relapse to cocaine use” NCT00373581 ↗ |
| Known as | Kigabeq | ChEMBL registry synonym — accepted as the source's own label CHEMBL89598 ↗ |
| Known as | MDL 71,754 | ChEMBL registry synonym — accepted as the source's own label CHEMBL89598 ↗ |
| Known as | RMI-71754 | ChEMBL registry synonym — accepted as the source's own label CHEMBL89598 ↗ |
| Known as | Sabril | “The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets...” NCT02220114 ↗2“Subjects will begin taking vigabatrin (Sabril) during the third month of the study.” NCT01266291 ↗ |
| Known as | VGB | “oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions” NCT00626834 ↗1“Vigabatrin (VGB)” NCT02299115 ↗ |
| Known as | Vigabatrina | ChEMBL registry synonym — accepted as the source's own label CHEMBL89598 ↗ |
| Known as | Vigabatrine | ChEMBL registry synonym — accepted as the source's own label CHEMBL89598 ↗ |
| Known as | Vigafyde | ChEMBL registry synonym — accepted as the source's own label CHEMBL89598 ↗ |
| Known as | Vinyl gamma-aminobutyric acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL89598 ↗ |
| Action | Inhibit | “VGB is an irreversible, enzyme-activated, selective inhibitor of GABA-transaminase” NCT02299115 ↗1“Gamma-amino-N-butyrate transaminase inhibitor” CHEMBL89598 ↗ |
| Modality | Small molecule | — CHEMBL89598 ↗ |
| Route | Oral | “oral vigabatrin” NCT00626834 ↗ |
| Target | ABAT | “Gamma-amino-N-butyrate transaminase inhibitor” CHEMBL89598 ↗ |