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 · 6 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 ↗ |
| Filed | US (FDA) | — | — | 2018-05-02 | “Amneal has also filed an ANDA with US FDA for the tablet form of vigabatrin.” amneal.com ↗ |
| Approved | US (FDA) | SABRIL | — | 2009-08-21 | fda.gov ↗ |
Trials 14
| 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 · 3 missed | ||||||
| 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 | Missed primary |
| Phase 2 | NCT01335867 | Apr 2011 → Apr 2013 | alcohol dependence, cocaine dependence | University of Pennsylvania | Terminated | Missed primary |
| Phase 2 | NCT00611130 | Jan 2008 → May 2009 | cocaine dependence | Catalyst Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 2 | NCT00373581 | Apr → Dec 2006 | cocaine dependence | New York State Psychiatric Institute | Terminated | No outcome recorded Stop: Business |
| 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| Phase 4 | NCT01413711 | Jun 2012 → Sep 2013 | infantile spasms | Lundbeck LLC | Withdrawn | No outcome recorded |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 Stop: Enrollment |
| 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 |
| Comparator or background therapy12 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 2/3 | NCT01281202 Comparator | Jan 2011 → Oct 2012 | cocaine dependence | Catalyst Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05128344 Comparator | Apr 2023 → Jun 2025 | infantile spasms | Amzell | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03421496 Background | Sep 2018 → May 2019 | infantile spasms | Radius Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03347526 Comparator | Apr 2018 → Jun 2021 | infantile spasms | University of Colorado, Denver | Suspended | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02299115 Comparator | Sep 2017 → Mar 2019 | infantile spasms | The Hospital for Sick Children | Withdrawn | No outcome recorded |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-03-03 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution USP, 500 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Vigabatrin for Oral Solution USP, 500 mg (USRLD: Sabril® for Oral Solution). |
| 2022-03-11 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Vigabatrin for Oral Solution USP lupin.com ↗
Mumbai, Baltimore, March 11, 2022: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Vigabatrin for Oral Solution USP, 500 mg to market a generic equivalent of Sabril® for Oral Solution, 500 mg of Lundbeck Pharmaceuticals, LLC. |
| 2022-01-20 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Vigabatrin Tablets zyduslife.com ↗
Zydus has received final approval from the USFDA to market Vigabatrin Tablets in the strength of 500 mg (US RLD: Sabril Tablets). |
| 2015-06-24 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceuticals Announces Encouraging Top-Line Results in Proof-of-Concept Trial of Vigabatrin in Patients With Treatment-Refractory Tourette's Disorder globenewswire.com ↗
One of four patients demonstrated a very clear, clinically significant reduction in tics, and two others showed about a 25% reduction in tics, but without subjective clinical improvement. |
| 2012-11-08 | Catalyst Pharmaceuticals, Inc. | Results Catalyst Pharmaceutical Partners Announces Top-Line Results of CPP-109 Phase II(b) Trial for Cocaine Addiction globenewswire.com ↗
The data from the trial showed that CPP-109 did not meet the primary endpoint -- that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 8 and 9). |
| 2012-06-28 | Catalyst Pharmaceuticals, Inc. | Results Scientific Paper Describing the Ocular Safety of Short-Term Vigabatrin Treatment for Cocaine Addiction in Online Edition of American Journal of Ophthalmology globenewswire.com ↗
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) today announced that an ePublication on CPP-109 (vigabatrin) describing ocular safety results obtained with CPP-109 (vigabatrin) was published in the June 14, 2012 web edition of the American Journal of Ophthalmology (AJO). |
All press releases naming this drug 22 releases
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 ↗ |