vigabatrin
Trade name: sabril
Approved
Aug 21, 2009
Vigabatrin is an anticonvulsant chemically unrelated to other anticonvulsants. Vigabatrin prevents the catabolism of GABA by irreversibly inhibiting the enzyme GABA transaminase. It is an analog of GABA, but it is not a receptor agonist. However, vigabatrin is not a potent inhibitor of GABA-T with a Ki of 10 mM. Vigabatrin increases brain concentrations of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the CNS, by irreversibly inhibiting enzymes that catabolize GABA (gamma-aminobutyric acid transaminase, GABA-T). Duration of action is determined by rate of GABA-T re-synthesis. Vigabatrin may also work by suppressing repetitive neuronal firing through inhibition of voltage-sensitive sodium channels. Although administered as a racemic mixture, only the S(+) enantiomer is pharmacologically active. Vigabatrin is sold under the trade name SABRIL, it is indicated as adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. — NCATS
Clinical trial activity
26 trials · 38 clinical orgs · 32 marketing orgs
Earliest trial started Apr 1, 2006 (NCT00373581)
Timeline
2000s
2010s
- Jan 1, 2016
Earliest Phase 3 Sponsor(trial)
- Apr 27, 2017
Par Pharmaceuticals — Marketing Organization
- Apr 27, 2017
Bristol-Myers Squibb — Marketing Organization
- Apr 27, 2017
Endo Pharmaceuticals — Marketing Organization
- Apr 27, 2017
PH HEALTH — Marketing Organization
- Mar 13, 2018
Amneal Pharmaceuticals — Marketing Organization
- Apr 23, 2018
Teva — Marketing Organization
- Jun 21, 2018
Aucta Pharms — Marketing Organization
- Nov 20, 2018
Dr. Reddy's Laboratories — Marketing Organization
- Dec 3, 2019
Invagen Pharms — Marketing Organization
- Dec 3, 2019
Cipla — Marketing Organization
2020s
- Apr 27, 2020
Granules India — Marketing Organization
- Nov 13, 2020
Accord Research — Marketing Organization
- Dec 2, 2020
Alkem Labs Ltd — Marketing Organization
- Jan 26, 2021
Annora Pharma — Marketing Organization
- May 13, 2021
Dexcel Pharma Technologies Ltd. — Marketing Organization
- Jul 28, 2021
Specgx Llc — Marketing Organization
- Jul 28, 2021
Mallinckrodt (2013) — Marketing Organization
- Jul 29, 2021
Propel Pharma — Marketing Organization
- Jul 29, 2021
Navisci — Marketing Organization
- Sep 29, 2021
Aurobindo Pharma — Marketing Organization
- Jan 19, 2022
Zydus Discovery DMCC — Marketing Organization
- Mar 10, 2022
Lupin — Marketing Organization
- Mar 10, 2022
Chartwell Pharmaceuticals — Marketing Organization
- Jun 24, 2022
Elite Laboratories, Inc — Marketing Organization
- Jun 24, 2022
PYROS PHARMS — Marketing Organization
- Aug 29, 2022
Hikma — Marketing Organization
- Sep 7, 2022
MSN Laboratories — Marketing Organization
- Apr 28, 2023
RYAN LABS — Marketing Organization
- Apr 28, 2023
CARNEGIE — Marketing Organization
- Jun 29, 2023
ZENARA — Marketing Organization
- Jun 29, 2023
Upsher-Smith Laboratories — Marketing Organization
Indications
Approved for
Studied for
- Alcoholism · Phase 2
- Cocaine-Related Disorders · Phase 2/Phase 3
- Coma · Phase 2
- Epilepsy · Phase 4
- Glucose Intolerance · Phase 2
- Hyperinsulinism · Phase 2
- Hypertension · Phase 2
- Insulin Resistance · Phase 2
- Intellectual Disability · Phase 4
- Methamphetamine · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 2
- Obesity · Phase 2
- Seizures · Phase 4
- Status Epilepticus · Phase 2
- Therapeutic Equivalency · Phase 1
- Tourette Syndrome · Phase 1/Phase 2
- Tuberous Sclerosis · Phase 2/Phase 3
Mechanism of action
- Gamma-amino-N-butyrate transaminaseINHIBITOR
ABAT inhibitor
Irreversible inhibitor
Approval history
- approvedAug 21, 2009
Chemistry & pharmacology
SMILES
NC(CCC(O)=O)C=C- Mol. weight
- 129.157 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaVigabatrin ↗
- NCATSGR120KRT6K ↗
- ChEMBLCHEMBL89598 ↗
Also known as
- (+/-)-4-amino-5-hexenoic acid
- 4-amino-5-hexenoic acid
- 4-amino-5-hexenoic acid
- cpp-109
- cpp-109
- gamma vinyl gaba
- gamma vinyl gaba
- gamma-vinyl gaba
- gamma-vinyl gaba
- gamma-vinyl gaba
- gamma-vinyl-gamma-aminobutyric acid
- gamma-vinyl-gamma-aminobutyric acid
- gvg
- gvg
- mdl-71754
- mdl-71754
- sabril
- sabril
- sabril
- sabril
- sabril
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrin
- vigabatrina
- vigabatrina
- vigabatrine
- vigabatrine
- vigabatrin hcl
- vigabatrin hydrochloride
- vigabatrinum
- vigabatrinum
- vinyl gamma-aminobutyric acid
- vinyl gamma-aminobutyric acid
- vinyl gamma-aminobutyric acid
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05128344 | Phase 3 | Dec 20, 2021 | Amzell |
| NCT04772547 | Phase 2 | Jul 31, 2021 | Thomas Jefferson University, University of Florida, Yale University |
| NCT04987463 | Phase 2/Phase 3 (Phase 3) | May 7, 2021 | Children's Memorial Health Institute, Poland, The Children's Memorial Health Institute |
| NCT04321395 | Phase 2 | Jun 30, 2020 | Washington University in St. Louis |
| NCT04302116 | N/A | Apr 30, 2020 | Queen Sirikit National Institute of Child Health |
| NCT04062890 | Phase 2 | Dec 15, 2019 | Arizona Department of Health Services, University of Arizona |
| NCT03421496 | Phase 3 | Sep 5, 2018 | Insys Therapeutics Inc |
| NCT03347526 | Phase 3 | Apr 19, 2018 | Pediatric Epilepsy Research Foundation, University of Colorado, University of Colorado, Denver, West Therapeutics, Inc |
| NCT04468282 | Phase 1 | Apr 4, 2017 | Orphelia Pharma SA |
| NCT02849457 | Phase 2 | Dec 1, 2016 | National Institute of Neurological Disorders and Stroke (NINDS), University of Alabama, Birmingham |
| NCT03003143 | N/A | Nov 1, 2016 | Seoul National University |
| NCT02299115 | Phase 3 | Sep 1, 2016 | University of Toronto |
| NCT02220114 | N/A | May 1, 2014 | Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France, Orphelia Pharma SA, University of Lyon |
| NCT01585207 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2012 | Icahn School of Medicine at Mount Sinai, New York University |
| NCT01413711 | Phase 4 | Jun 1, 2012 | Lundbeck |
| NCT01335867 | Phase 2 | Apr 1, 2011 | National Institute on Drug Abuse (NIDA), University of Pennsylvania |
| NCT01281202 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2011 | Catalyst Pharmaceuticals, Inc., Department of Veteran Affairs, Medical University of South Carolina, National Institute on Drug Abuse (NIDA) |
| NCT01278173 | Phase 4 | Dec 1, 2010 | Lundbeck |
| NCT01266291 | Phase 4 | Aug 1, 2010 | University of Pennsylvania |
| NCT00730522 | Phase 2 | Jul 1, 2008 | Catalyst Pharmaceuticals, Inc. |
Organizations
Research & Development (38)
Marketing (37)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Nov 13, 2020 |
| Alkem Labs Ltd | For profit | MKTG | Dec 2, 2020 |
| Amneal Pharmaceuticals | For profit | MKTG | Mar 13, 2018 |
| Annora Pharma | For profit | MKTG | Jan 26, 2021 |
| Aucta Pharms | For profit | SYN | Jun 21, 2018 |
| Aucta Pharms | For profit | MKTG | Jun 21, 2018 |
| Aurobindo Pharma | For profit | MKTG | Sep 29, 2021 |
| Bristol-Myers Squibb | For profit | MKTG | Apr 27, 2017 |
| CARNEGIE | For profit | MKTG | Apr 28, 2023 |
| Chartwell Pharmaceuticals | For profit | MKTG | Mar 10, 2022 |
| Cipla | For profit | MKTG | Dec 3, 2019 |
| Dexcel Pharma Technologies Ltd. | For profit | MKTG | May 13, 2021 |
| Dexcel Pharma Technologies Ltd. | For profit | SYN | May 13, 2021 |
| Dr. Reddy's Laboratories | For profit | MKTG | Nov 20, 2018 |
| Dr. Reddy's Laboratories | For profit | SYN | Jan 29, 2021 |
| Elite Laboratories, Inc | For profit | MKTG | Jun 24, 2022 |
| Endo Pharmaceuticals | For profit | MKTG | Apr 27, 2017 |
| Granules India | For profit | MKTG | Apr 27, 2020 |
| Granules India | For profit | SYN | Apr 24, 2020 |
| Hikma | For profit | MKTG | Aug 29, 2022 |
| Invagen Pharms | For profit | MKTG | Dec 3, 2019 |
| Lundbeck | For profit | NDA | Aug 21, 2009 |
| Lupin | For profit | MKTG | Mar 10, 2022 |
| MSN Laboratories | For profit | MKTG | Sep 7, 2022 |
| Mallinckrodt (2013) | For profit | MKTG | Jul 28, 2021 |
| Navisci | For profit | MKTG | Jul 29, 2021 |
| PH HEALTH | For profit | MKTG | Apr 27, 2017 |
| PYROS PHARMS | For profit | MKTG | Jun 24, 2022 |
| Par Pharmaceuticals | For profit | MKTG | Apr 27, 2017 |
| Propel Pharma | For profit | MKTG | Jul 29, 2021 |
| RYAN LABS | For profit | MKTG | Apr 28, 2023 |
| Specgx Llc | For profit | MKTG | Jul 28, 2021 |
| Teva | For profit | MKTG | Apr 23, 2018 |
| Upsher-Smith Laboratories | For profit | MKTG | Jun 29, 2023 |
| ZENARA | For profit | MKTG | Jun 29, 2023 |
| Zydus Discovery DMCC | For profit | MKTG | Jan 19, 2022 |
| Zydus Discovery DMCC | For profit | SYN | Jan 19, 2022 |