Drugs / Lacosamide
last change Jan 2026 re-read 2 minutes ago

Lacosamide

Other / unclassified targets SCN9A via inhibition

Developed for
epilepsy · focal epilepsy · diabetic polyneuropathy · diabetic neuropathy · migraine disorder · postherpetic neuralgia · traumatic brain injury · alcohol-related disorders
+17 more · neuropathy, painful · Alzheimer disease 3 · amyotrophic lateral sclerosis · bipolar disorder · brain hypoxia - ischemia · cardiac arrest · chronic pain syndrome · chronic pancreatitis · fibromyalgia · intracerebral hemorrhage · malignant glioma · neonatal epilepsy syndrome · neuropathy, small fiber · osteoarthritis, knee · respiratory underresponsiveness to hypoxia and hypercapnia · sciatica · brain glioma
Investigated by
UCB Pharma · UCB BIOSCIENCES, Inc. · UCB Japan Co. Ltd. · UCB Biopharma SRL · Eden Sarl · Indiana University
+46 more · Kafrelsheikh University · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Parexel · SCHWARZ BIOSCIENCES GmbH - Part of UCB Group · UCB Biopharma S.P.R.L. · Aatif Husain · Beijing Capton Pharmaceutical Technology Development Co., LTD · Belgium Health Care Knowledge Centre · Boston Medical Center · Brigham and Women's Hospital · CMH Kharian Medical College · Chiba University · Erasme University Hospital · Evan Fertig · Hannover Medical School · Juntendo University · Leiden University Medical Center · Libbs Farmacêutica LTDA · M.D. Anderson Cancer Center · Maastricht University Medical Center · Michigan State University · National Cancer Institute (NCI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Overseas Pharmaceuticals, Ltd. · Pakistan Institute of Medical Sciences · Pharmaceutical Research Associates · RIKEN · Riphah International University · San Francisco VA Health Care System · Second Affiliated Hospital, School of Medicine, Zhejiang University · Tanta University · Technical University of Munich · The Cleveland Clinic · Tongji Hospital · University of Alabama at Birmingham · University of California, Los Angeles · University of California, San Francisco · University of Kiel · University of North Carolina, Chapel Hill · University of Sao Paulo · University of Twente · VA Office of Research and Development · Wake Forest University Health Sciences · Xiangya Hospital of Central South University · ZonMw: The Netherlands Organisation for Health Research and Development

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) MOTPOLY XR 2024-06-07 fda.gov
Label expansions (6) US (FDA) VIMPAT 2014-08-29 – 2023-04-28 fda.gov
Approved US (FDA) VIMPAT 2008-10-28 fda.gov
Approved EU (EMA) Vimpat 2008-08-29 europa.eu

Trials 84 · started per year

today
EU approved 2008
US approved 2008
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200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT05788159 Apr → Jun 2023 epilepsy Overseas Pharmaceuticals, Ltd. Unknown No outcome recorded
Phase 1 NCT05603702 Mar 2023 → Mar 2027 expected chronic pain syndrome, chronic pancreatitis Indiana University Active not recruiting No outcome recorded
Phase 1 NCT03271528 Apr 2018 → Aug 2020 alcohol-related disorders Boston Medical Center Completed No outcome recorded
Phase 1 NCT01530022 May 2012 → Jan 2014 UCB Pharma Completed No outcome recorded
Phase 1 NCT01530386 Jan → Jul 2012 UCB Pharma Completed No outcome recorded
Phase 1 NCT01375387 Mar → Jun 2011 UCB Pharma Completed No outcome recorded
Phase 1 NCT01450111 Nov 2008 → Feb 2009 epilepsy UCB Pharma Completed No outcome recorded
Phase 1 NCT01796938 Jun → Nov 2004 impaired renal function disease UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03186040 Jul 2017 → Apr 2020 amyotrophic lateral sclerosis Chiba University Completed No outcome recorded
Phase 220 trials
Phase 2 NCT04519645 Mar 2021 → Aug 2024 neonatal epilepsy syndrome UCB Biopharma SRL Terminated No outcome recorded
Phase 2 NCT03897348 Sep 2018 → Jun 2019 alcohol-related disorders University of California, San Francisco Completed No outcome recorded
Phase 2 NCT02342977 Nov 2014 → Aug 2016 avascular necrosis, osteoarthritis, rheumatoid arthritis Indiana University Withdrawn No outcome recorded
Phase 2 NCT01969851 Feb 2014 → Apr 2018 epilepsy UCB Pharma Completed No outcome recorded
Phase 2 NCT01724918 May 2013 → Aug 2016 focal epilepsy London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Terminated No outcome recorded
Phase 2 NCT01458522 May 2012 → Jul 2014 epilepsy Aatif Husain Completed No outcome recorded
Phase 2 NCT01118962 Aug 2010 → Oct 2012 epilepsy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 2 NCT01118949 May 2010 → Aug 2011 epilepsy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 2 NCT00938912 Dec 2009 → May 2021 epilepsy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 2 NCT00938431 Nov 2009 → Aug 2014 epilepsy UCB Pharma Completed No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT02710890 May 2017 → Jun 2019 epilepsy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 2/3 NCT00151879 Feb 2005 → May 2006 focal epilepsy UCB Pharma Completed No outcome recorded
Phase 2/3 NCT00235443 Sep 2004 → Jul 2008 diabetic neuropathy UCB Pharma Completed No outcome recorded
Phase 2/3 NCT00235469 Apr 2004 → Jun 2005 diabetic polyneuropathy UCB Pharma Completed No outcome recorded
Phase 335 trials
Phase 3 NCT07412132 Jan 2026 → Jan 2027 expected bipolar disorder University of Sao Paulo Recruiting No outcome recorded
Phase 3 NCT05632133 Jun 2022 → Aug 2023 migraine disorder Kafrelsheikh University Completed No outcome recorded
Phase 3 NCT05851781 Jun 2022 → Jul 2023 migraine disorder Kafrelsheikh University Completed No outcome recorded
Phase 3 NCT05291455 Mar 2022 → Mar 2024 epilepsy Tanta University Unknown No outcome recorded
Phase 3 NCT05626140 Sep 2021 → May 2022 sciatica Pakistan Institute of Medical Sciences Completed No outcome recorded
Phase 3 NCT04627285 Dec 2020 → Feb 2025 epilepsy UCB Biopharma SRL Completed No outcome recorded
Phase 3 NCT02582866 Jan 2016 → Jan 2020 epilepsy UCB Biopharma S.P.R.L. Completed No outcome recorded
Phase 3 NCT02408549 Aug 2015 → Mar 2023 epilepsy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 3 NCT02477839 Jun 2015 → May 2020 focal epilepsy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 3 NCT02408523 Apr 2015 → Apr 2019 epilepsy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 410 trials
Phase 4 NCT06866691 Apr 2025 → Apr 2027 expected traumatic brain injury Wake Forest University Health Sciences Recruiting No outcome recorded
Phase 4 NCT06081283 Nov 2023 → Dec 2024 brain hypoxia - ischemia, cardiac arrest, intracerebral hemorrhage, traumatic brain injury University of North Carolina, Chapel Hill Terminated No outcome recorded
Phase 4 NCT05969054 Jul 2023 → Dec 2025 Alzheimer disease 3, epilepsy Xiangya Hospital of Central South University Unknown No outcome recorded
Phase 4 NCT05598905 Oct 2022 → Jan 2024 respiratory underresponsiveness to hypoxia and hypercapnia Leiden University Medical Center Completed No outcome recorded
Phase 4 NCT04144218 Nov 2019 → Oct 2021 epilepsy Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
Phase 4 NCT02409433 Aug 2014 → Nov 2015 epilepsy London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Terminated No outcome recorded
Phase 4 NCT01190098 Aug 2010 → Nov 2014 focal epilepsy The Cleveland Clinic Completed No outcome recorded
Phase 4 NCT01235403 Jun 2010 → Dec 2011 focal epilepsy UCB Pharma Completed No outcome recorded
Phase 4 NCT01175954 May 2010 → Dec 2015 epilepsy Evan Fertig Completed No outcome recorded
Phase 4 NCT00955357 Aug 2009 → Apr 2013 focal epilepsy UCB Pharma Completed No outcome recorded
Phase not applicable5 trials
NCT06549426 Apr 2025 → Dec 2029 expected epilepsy University of Twente Recruiting No outcome recorded
NCT06969417 Apr → Jul 2025 overdue herpes zoster, postherpetic neuralgia CMH Kharian Medical College Recruiting No outcome recorded
NCT01432171 Jul 2012 → Jun 2017 malignant glioma M.D. Anderson Cancer Center Terminated No outcome recorded
NCT01382017 Jun 2011 → Aug 2012 University of Kiel Completed No outcome recorded
NCT01110187 May 2010 → May 2012 traumatic brain injury University of Alabama at Birmingham Terminated No outcome recorded
Phase not stated1 trial
NCT03559673 focal epilepsy UCB Biopharma S.P.R.L. No longer available No outcome recorded
Also used as a comparator or background therapy in 9 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT03436433 Comparator Jan 2019 → Dec 2020 brain glioma Duke University Terminated No outcome recorded
Phase 2 NCT03777956 Comparator Jan 2019 → Jun 2022 diabetic neuropathy, neuropathy, painful Danish Pain Research Center Terminated No outcome recorded
Phase 34 trials
Phase 3 NCT06243692 Comparator Feb 2024 → Feb 2025 migraine disorder Kafrelsheikh University Unknown No outcome recorded
Phase 3 NCT02726867 Comparator Feb 2014 → Nov 2016 epilepsy Mid-Atlantic Epilepsy and Sleep Center, LLC Withdrawn No outcome recorded
Phase 3 NCT01981447 Comparator Apr 2010 → Aug 2012 epilepsy Le Bonheur Children's Hospital Completed No outcome recorded
Phase 3 NCT00520741 Comparator Aug 2007 → Dec 2012 epilepsy UCB BIOSCIENCES, Inc. Completed No outcome recorded
Phase 42 trials
Phase 4 NCT03607851 Comparator Aug 2018 → Jun 2019 focal epilepsy Seoul National University Hospital Completed No outcome recorded
Phase 4 NCT00832884 Comparator Mar 2010 → May 2012 epilepsy Le Bonheur Children's Hospital Completed No outcome recorded
Phase not applicable1 trial
NCT03636958 Background Feb 2021 → Jul 2025 epilepsy Assistance Publique Hopitaux De Marseille Withdrawn No outcome recorded

Press releases naming this drug 12 releases

DateIssuerRelease
2020-02-27 Daiichi Sankyo Anti-epilepsy Drug VIMPAT ®, Submission for Supplemental Application for Approval in Japan daiichisankyo.com
2019-03-25 Daiichi Sankyo Anti-epilepsy Drug VIMPAT ® for I.V. infusion 200mg Launched in Japan daiichisankyo.com
2019-03-11 Daiichi Sankyo Anti-epilepsy Drug VIMPAT® Dry syrup 10% Launched in Japan daiichisankyo.com
2019-01-08 Daiichi Sankyo Pediatric Dosage and Administration Approved for Anti-epileptic Drug VIMPAT® Tablets 50 mg and 100 mg daiichisankyo.com
2017-09-01 Daiichi Sankyo Restriction on prescription period lifted for antiepileptic VIMPAT® Tablets 50 mg and 100 mg daiichisankyo.com
2017-08-25 Daiichi Sankyo Antiepileptic VIMPAT® Tablets 50 mg and 100 mg approved for monotherapy for Partial-onset Seizures in Epilepsy Patients daiichisankyo.com
2016-08-31 Daiichi Sankyo Antiepileptic Drug Vimpat® Tablets 50 mg and 100 mg have been launched. daiichisankyo.com
2016-08-26 Daiichi Sankyo Antiepileptic lacosamide filed for partial amendment of approval to add a new indication in Japan daiichisankyo.com
2016-07-04 Daiichi Sankyo UCB and Daiichi Sankyo announce Japanese approval of lacosamide (brand name VIMPAT®) as adjunctive therapy in the treatment of partial-onset seizures in adult patients with epilepsy daiichisankyo.com
2015-12-21 Daiichi Sankyo Results of Analysis of Data from Clinical Trial of Lacosamide (Generic Name) Announced at 2015 Annual Meeting of the American Epilepsy Society daiichisankyo.com
2015-06-26 Daiichi Sankyo Application for Marketing Authorization for Lacosamide (Generic Name) in Japan for the Treatment of Epilepsy daiichisankyo.com
2014-11-28 Daiichi Sankyo UCB and Daiichi Sankyo partner to bring Lacosamide to people living with epilepsy in Japan daiichisankyo.com

Evidence & citations 23 cited values

Every value below carries the sentence it was read from. 99 sources stand behind the page.

FieldValueCited text
Known as lacosamide “Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958
89

“This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in...” NCT00135109

“The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for...” NCT00136019

“This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic...” NCT00235469

“The purpose of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months.” NCT00220415

Lacosamide is a new antiepileptic drug effective for adjunctive treatment of partial-onset seizures.” PMID 20041945 Dec 2009

“400mg/Day and 600mg/Day SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy” NCT00238524

“a first parenteral anti-seizure medication (levetiracetam, valproate, or lacosamide)” NCT06549426

“long-term administration of LacosamideNCT00238511

NCT02582866

NCT00440518

NCT00655486

NCT00655551

NCT00485472

NCT06866691

NCT00220337

NCT00552305

NCT06081283

NCT05291455

NCT05598905

NCT00237458

NCT00861445

NCT01118962

NCT03897348

NCT01964560

NCT03559673

NCT01118949

NCT01243177

NCT00520741

NCT01375387

NCT05603702

NCT03271528

NCT00938912

NCT01235403

NCT00530855

NCT06969417

NCT02408549

NCT03607851

NCT01345058

NCT00955357

NCT02408523

NCT01832038

NCT02342977

NCT05626140

NCT01796938

NCT00938431

NCT02409433

NCT02726867

NCT01110187

NCT03186040

NCT02477839

NCT01484977

NCT01969851

NCT01382017

NCT01530022

NCT01921205

NCT01911975

NCT00235443

NCT00546351

NCT05851781

NCT03777956

NCT01432171

NCT02124564

NCT00515619

NCT00832884

NCT01375374

NCT06243692

NCT01724918

NCT05969054

NCT00522275

NCT01175954

NCT04519645

NCT07412132

NCT00861068

NCT00401830

NCT02374567

NCT02192814

NCT05788159

NCT03436433

NCT00861042

NCT02710890

NCT04627285

NCT04144218

NCT01465997

NCT01450111

NCT01190098

NCT01710657

NCT01981447

NCT01530386

NCT05632133

Known as (r)-lacosamide 1 ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as [R]-2-acetamido-N-benzyl-3-methoxypropionamide “Lacosamide ([R]-2-acetamido-N-benzyl-3-methoxypropionamide) belongs to a novel class of functionalized amino acids.” NCT01190098
Known as ADD 243037 ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as Erlosamide ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as Lacosamida ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as Lacosamide accord ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as Lacosamide adroiq ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as Lacosamide cv ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as Lacosamide extended release tablets “Test preparation (T): Lacosamide extended release tablets Specification: 100mg/tablet Lot number: 22121301 Content: 100mg/tablet Expiration date: December 12, 2024 Storage...” NCT05788159
Known as Lacosamide Tablets “Reference preparation (R): Lacosamide Tablets Specification: 50mg/tablet Lot No.: 7883201 Content: 50mg/tablet Expiration date: September 2026 Storage condition: not more than...” NCT05788159
Known as Lacosamide ucb ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as LCM “The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR)...” NCT01530022
7

“continued access to Lacosamide (LCM) for monotherapy use” NCT03559673

“lacosamide (LCM) added to levetiracetam (LEV)” PMID 27714769 Oct 2016

“Strength: Lacosamide (LCM) 50 mg, LCM 100 mg” NCT01832038

“start dose Lacosamide (LCM) is 100 mg/day” NCT01375374

“lacosamide (LCM)” NCT01382017

“Lacosamide (LCM)” NCT01243177

NCT01458522

Known as Motpoly ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as Motpoly xr ChEMBL registry synonym — accepted as the source's own label CHEMBL58323
Known as SPM 927 “Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target...” NCT00220415
6

“The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for...” NCT00136019

“400mg/Day and 600mg/Day SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy” NCT00238524

“Oral SPM 927NCT00238511

NCT00235469

NCT00135109

NCT00800215

Known as SPM 929 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00350103
Known as SPM927 / Lacosamide / Vimpat SPM927 / Lacosamide / Vimpat®” NCT00861042
Known as Vimpat “The purpose of this study is to investigate the impact of the anti-seizure medication Lacosamide (Vimpat®) on sleep and wakefulness in adults with focal (partial onset) seizures.” NCT01190098
3

“INTERVENTION: Four- to six-week Titration Phase followed by 12-week maintenance treatment with adjunctive lacosamide (Vimpat®) [200, 400 or 600 mg/day] or placebo.” PMID 21090839 Dec 2010

“Lacosamide, Vimpat®” NCT00861068

“Lacosamide, Vimpat®” NCT00861445

Action Inhibit “This mechanism of action results in stabilization of hyperexcitable neuronal membranes, inhibition of neuronal firing, and reduction in long-term channel availability without...” PMID 23859801 Jul 2013
Modality Other / unclassified “belongs to a novel class of functionalized amino acids.” NCT01190098
Route Oral “The efficacy and tolerability of oral lacosamide (200, 400, and 600 mg/day) was evaluated in patients with painful diabetic neuropathy” PMID 19409861 May 2009
Target SCN9A “The finding of voltage-gated sodium channel mutations in small fibre neuropathy (with mutations in SCN9A, encoding for Nav1.7) being most frequently reported suggest a specific...” PMID 30649227 Feb 2019