lacosamide
Trade name: vimpat
Approved
Oct 28, 2008
Lacosamide is an anticonvulsant that is FDA approved for the treatment of partial-onset seizures. The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing Common adverse reactions include diplopia, headache, dizziness, nausea. Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to Lacosamide tablets. — NCATS
Clinical trial activity
99 trials · 56 clinical orgs · 26 marketing orgs
Earliest trial started May 1, 2001 (NCT00237458)
Timeline
2000s
2010s
- Oct 28, 2015
Glenmark Pharmaceuticals — Marketing Organization
- Apr 28, 2016
Mylan — Marketing Organization
- Feb 6, 2017
Accord Research — Marketing Organization
- Feb 28, 2017
Teva — Marketing Organization
- Oct 27, 2017
Alembic — Marketing Organization
- Oct 27, 2017
Aurobindo Pharma — Marketing Organization
- Aug 16, 2018
Apotex — Marketing Organization
- Apr 5, 2019
Zydus Discovery DMCC — Marketing Organization
- May 9, 2019
Hetero Labs Ltd — Marketing Organization
2020s
- Sep 21, 2020
Sciegen Pharmaceticals — Marketing Organization
- Mar 12, 2021
Alkem Labs Ltd — Marketing Organization
- Mar 17, 2022
Amneal Pharmaceuticals — Marketing Organization
- Mar 17, 2022
Indoco Remedies — Marketing Organization
- Mar 17, 2022
MSN Laboratories — Marketing Organization
- Mar 17, 2022
Sun Pharmaceuticals — Marketing Organization
- May 3, 2022
Fresenius — Marketing Organization
- Aug 26, 2022
Novitium Pharma — Marketing Organization
- Aug 26, 2022
Ani Pharmaceuticals — Marketing Organization
- Sep 14, 2022
Aspiro — Marketing Organization
- Sep 19, 2022
Gland Pharma Ltd — Marketing Organization
- Sep 19, 2022
Fosun — Marketing Organization
- Jan 5, 2023
Actavis — Marketing Organization
- Jan 5, 2023
AbbVie — Marketing Organization
- Feb 6, 2023
Medley Pharmaceutical Industry SA — Marketing Organization
- May 4, 2023
Aucta Pharms — Marketing Organization
- May 4, 2023
Aucta Pharms — NDA Secondary Org
Indications
Studied for
- Abdominal Pain · Phase 1
- Acute Kidney Injury · Phase 4
- Alcoholism · Phase 2
- Alzheimer Disease · Phase 4
- Amyotrophic Lateral Sclerosis · Phase 1/Phase 2
- Anxiety Disorders · Phase 3
- Arthritis, Rheumatoid · Phase 2
- Brain Injuries · Phase 4
- Brain Injuries, Traumatic · Phase 4
- Brain Ischemia · Phase 4
- Brain Neoplasms · Phase 2
- Cholangiopancreatography, Endoscopic Retrograde · Phase 1
- Chronic Pain · Phase 2
- Coma · Phase 4
- Dementia · Phase 3
- Depression · Phase 4
- Diabetic Neuropathies · Phase 3
- Drug Resistant Epilepsy · Phase 4
- Epilepsies, Partial · Phase 4
- Fibromyalgia · Phase 2
- General Surgery · Phase 1
- Glioma · Phase 4
- Healthy Volunteers · Phase 1
- Heart Arrest · Phase 4
- Hyperalgesia · Phase 1
- Hypoxia, Brain · Phase 4
- Hypoxia-Ischemia, Brain · Phase 4
- Intracranial Hemorrhages · Phase 4
- Kidney Failure, Chronic · Phase 1
- Migraine Disorders · Phase 3
- Neoplasms · Phase 4
- Neuralgia · Phase 2
- Neuralgia, Postherpetic · Phase 2
- Opioid-Related Disorders · Phase 1
- Osteoarthritis · Phase 2
- Pain · Phase 2
- Pancreatitis, Chronic · Phase 1
- Peripheral Nerve Injuries · Phase 2
- Peripheral Nervous System Diseases · Phase 2
- Persistent Vegetative State · Phase 4
- Pharmacokinetics · Phase 4
- Psychophysiologic Disorders · Phase 3
- Renal Insufficiency · Phase 4
- Schizophrenia · Phase 3
- Sciatica · Phase 3
- Small Fiber Neuropathy · Phase 3
- Status Epilepticus · Phase 3
- Stroke · Phase 4
- Vascular Diseases · Phase 2
Mechanism of action
- Sodium channel alpha subunitBLOCKER
Sodium channel alpha subunit blocker
- Sodium channel protein type 1 subunit alpha (SCN1A) ↗
- Sodium channel protein type 5 subunit alpha (SCN5A) ↗
- Sodium channel protein type 4 subunit alpha (SCN4A) ↗
- Sodium channel protein type 7 subunit alpha (SCN7A) ↗
- Sodium channel protein type 2 subunit alpha (SCN2A) ↗
- Sodium channel protein type 9 subunit alpha (SCN9A) ↗
- Sodium channel protein type 3 subunit alpha (SCN3A) ↗
- Sodium channel protein type 11 subunit alpha (SCN11A) ↗
- Sodium channel protein type 8 subunit alpha (SCN8A) ↗
- Sodium channel protein type 10 subunit alpha (SCN10A) ↗
- Sodium channel protein type I alpha subunit
- Sodium channel protein type V alpha subunit
- Sodium channel protein type IV alpha subunit
- Sodium channel protein type VII alpha subunit
- Sodium channel protein type IX alpha subunit
- Sodium channel protein type II alpha subunit
- Sodium channel protein type III alpha subunit
- Sodium channel protein type XI alpha subunit
- Sodium channel protein type VIII alpha subunit
- Sodium channel protein type X alpha subunit
- Sodium channel alpha subunits; brain (Types I, II, III)
Approval history
- approvedOct 28, 2008
Chemistry & pharmacology
SMILES
COC[C@@H](NC(C)=O)C(=O)NCC1=CC=CC=C1- Mol. weight
- 250.2936 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- WikipediaLacosamide ↗
- NCATS563KS2PQY5 ↗
- ChEMBLCHEMBL58323 ↗
Also known as
- 2-(acetylamino)-3-methoxy-n-(phenylmethyl)-, (2r)-
- add-234037
- add-243037
- add-243037
- erlosamide
- erlosamide
- erlosamide
- erlosamide
- ertosamide
- ertosamide
- ertosamide
- ertosamide
- ertosamide
- ertosamide
- harkoseride
- harkoseride
- harkoseride
- harkoseride
- lacosamide
- lacosamide
- lacosamide
- lacosamide
- lacosamide
- lacosamide
- lacosamide
- lacosamide
- lacosamide
- lacosamide
- lacosmide
- lasosamide
- n-benzyl-2-acetamido-3-methoxypropionamide
- n-benzyl-acmeoprnh2
- spm927
- spm-927
- spm-927
- spm-927
- spm-927
- spm 929
- spm 929
- vimpat
- vimpat
- vimpat
- vimpat
- vimpat
- vimpat
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06866691 | Phase 4 | Apr 30, 2025 | Wake Forest University |
| NCT06969417 | N/A | Apr 10, 2025 | CMH Kharian Medical College |
| NCT06243692 | Phase 3 | Feb 1, 2024 | Kafrelsheikh University |
| NCT06081283 | Phase 4 | Nov 20, 2023 | University of North Carolina at Chapel Hill |
| NCT05969054 | Phase 4 | Jul 5, 2023 | Central South University |
| NCT05788159 | Phase 1 | Apr 1, 2023 | Overseas Pharmaceuticals, Ltd. |
| NCT05603702 | Phase 1 | Nov 30, 2022 | Indiana University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT05598905 | Phase 4 | Oct 10, 2022 | Leiden University |
| NCT05510856 | Phase 4 | Sep 1, 2022 | Tanta University |
| NCT05632133 | Phase 3 | Jun 1, 2022 | Kafrelsheikh University |
| NCT05851781 | Phase 3 | Jun 1, 2022 | Kafrelsheikh University |
| NCT05291455 | Phase 3 | Mar 1, 2022 | Kafrelsheikh University, Tanta University |
| NCT05626140 | Phase 3 | Sep 28, 2021 | Government of Pakistan, Riphah International University |
| NCT04519645 | Phase 2/Phase 3 (Phase 3) | Mar 31, 2021 | UCB |
| NCT04627285 | Phase 3 | Dec 31, 2020 | UCB |
| NCT04650204 | Phase 4 | Dec 15, 2020 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT04144218 | Phase 4 | Nov 30, 2019 | Zhejiang University |
| NCT03777956 | Phase 2 | Jan 15, 2019 | Aarhus University, University of Southern Denmark |
| NCT03436433 | Phase 2 | Aug 25, 2018 | Duke University |
| NCT03607851 | Phase 4 | Jul 31, 2018 | Keimyung University, Konkuk University, Seoul National University |
Organizations
Research & Development (56)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Hoosier Cancer Research Network | Academic/Hospital | 64 | 56 | 5 | 2001 |
| UCB | For profit | 5 | 5 | 3 | 2012 |
| Kafrelsheikh University | Academic/Hospital | 4 | 3 | 1 | 2022 |
| Department of Veteran Affairs | Government | 2 | 0 | 1 | 2014 |
| Duke University | Academic/Hospital | 2 | 2 | 1 | 2012 |
| Indiana University | Academic/Hospital | 2 | 2 | 2 | 2014 |
| Parexel | For profit | 2 | 0 | 1 | 2014 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | 2 | 0 | 1 | 2014 |
| Tanta University | Academic/Hospital | 2 | 2 | 2 | 2022 |
| University of Tennessee | Academic/Hospital | 2 | 2 | 2 | 2010 |
| University of Western Ontario | Academic/Hospital | 2 | 2 | 2 | 2013 |
| Aarhus University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Boston University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Brain Tumor Trials Collaborative | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Central South University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Chiba University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Christian Albrechts University | Academic/Hospital | 1 | 0 | 1 | 2011 |
| CMH Kharian Medical College | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Gottfried Wilhelm Leibniz Universität Hannover | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Government of Pakistan | Government | 1 | 1 | 1 | 2021 |
Marketing (34)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Jan 5, 2023 |
| Accord Research | For profit | SYN | Jul 12, 2022 |
| Accord Research | For profit | MKTG | Feb 6, 2017 |
| Actavis | For profit | MKTG | Jan 5, 2023 |
| Alembic | For profit | MKTG | Oct 27, 2017 |
| Alembic | For profit | SYN | Mar 17, 2022 |
| Alkem Labs Ltd | For profit | MKTG | Mar 12, 2021 |
| Amneal Pharmaceuticals | For profit | MKTG | Mar 17, 2022 |
| Ani Pharmaceuticals | For profit | MKTG | Aug 26, 2022 |
| Apotex | For profit | MKTG | Aug 16, 2018 |
| Apotex | For profit | SYN | Sep 23, 2022 |
| Aspiro | For profit | MKTG | Sep 14, 2022 |
| Aucta Pharms | For profit | MKTG | May 4, 2023 |
| Aucta Pharms | For profit | NDA2 | May 4, 2023 |
| Aurobindo Pharma | For profit | MKTG | Oct 27, 2017 |
| Fosun | For profit | MKTG | Sep 19, 2022 |
| Fresenius | For profit | MKTG | May 3, 2022 |
| Gland Pharma Ltd | For profit | MKTG | Sep 19, 2022 |
| Glenmark Pharmaceuticals | For profit | MKTG | Oct 28, 2015 |
| Hetero Labs Ltd | For profit | SYN | May 31, 2022 |
| Hetero Labs Ltd | For profit | SYN | Mar 17, 2022 |
| Hetero Labs Ltd | For profit | MKTG | May 9, 2019 |
| Indoco Remedies | For profit | MKTG | Mar 17, 2022 |
| MSN Laboratories | For profit | MKTG | Mar 17, 2022 |
| MSN Laboratories | For profit | SYN | Feb 9, 2023 |
| Medley Pharmaceutical Industry SA | For profit | MKTG | Feb 6, 2023 |
| Mylan | For profit | MKTG | Apr 28, 2016 |
| Novitium Pharma | For profit | MKTG | Aug 26, 2022 |
| Sciegen Pharmaceticals | For profit | MKTG | Sep 21, 2020 |
| Sun Pharmaceuticals | For profit | MKTG | Mar 17, 2022 |
| Teva | For profit | MKTG | Feb 28, 2017 |
| UCB | For profit | NDA | Oct 28, 2008 |
| Zydus Discovery DMCC | For profit | SYN | Jun 29, 2022 |
| Zydus Discovery DMCC | For profit | MKTG | Apr 5, 2019 |