Drugs / Lacosamide
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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 · 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, painful · 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
+48 more · Kafrelsheikh University · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Parexel · 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 · Patient-Centered Outcomes Research Institute · Pharmaceutical Research Associates · RIKEN · Riphah International University · SCHWARZ BIOSCIENCES GmbH - Part of UCB Group · 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 Michigan · 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 · 11 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed epilepsy with generalized tonic-clonic seizures 1 milestone
Filed Japan (PMDA) VIMPAT epilepsy with generalized tonic-clonic seizures 2020-02-27

“a supplemental application for VIMPAT® (generic name: lacosamide) was filed in Japan to expand the indication for adjunctive therapy for tonic-clonic seizures in epilepsy patients” daiichisankyo.com ↗

Filed simple partial epilepsy 1 milestone
Filed Japan (PMDA) — simple partial epilepsy 2015-06-26

“UCB Japan has applied for marketing authorization for lacosamide in Japan as adjunctive therapy in the treatment of partial onset seizures” daiichisankyo.com ↗

Approved Indication not stated 4 milestones
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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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials · 1 met primary
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 Met primary
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 · 1 met primary · 1 missed
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 Stop: Enrollment
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 Stop: Enrollment
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 · 1 met primary
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 Met primary
Phase 334 trials · 8 met primary · 3 missed
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 Met primary
Phase 3 NCT02477839 Jun 2015 → May 2020 focal epilepsy UCB BIOSCIENCES, Inc. Completed Missed primary
Phase 3 NCT02408523 Apr 2015 → Apr 2019 epilepsy UCB BIOSCIENCES, Inc. Completed Met primary
Phase 411 trials
Phase 4 NCT07795593 Oct 2026 → May 2031 expected diabetic kidney disease, diabetic neuropathy University of Michigan Not yet recruiting No outcome recorded
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 Stop: Enrollment
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 Stop: Enrollment
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 not applicable5 trials
— NCT06969417 Apr → Jul 2025 overdue herpes zoster, postherpetic neuralgia CMH Kharian Medical College Recruiting No outcome recorded
— NCT06549426 Apr 2025 → Dec 2029 expected epilepsy University of Twente 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 Stop: Enrollment
Phase not stated1 trial
— NCT03559673 — focal epilepsy UCB Biopharma S.P.R.L. No longer available No outcome recorded
Comparator or background therapy9 trials
Phase 2 NCT03436433 Comparator Jan 2019 → Dec 2020 brain glioma Duke University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03777956 Comparator Jan 2019 → Jun 2022 diabetic neuropathy, neuropathy, painful Danish Pain Research Center Terminated No outcome recorded Stop: Enrollment
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 Stop: Enrollment
Phase 3 NCT01981447 Comparator Apr 2010 → Aug 2012 epilepsy Le Bonheur Children's Hospital Completed No outcome recorded

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2023-12-16 Zydus Lifesciences Limited Regulatory Zydus receives final approval from the USFDA for Lacosamide Tablets zyduslife.com ↗
Zydus receives final approval from the USFDA for Lacosamide Tablets
2022-03-21 Glenmark Pharmaceuticals Ltd. India Regulatory Glenmark receives ANDA approval for Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg glenmarkpharma.com ↗
The FDA approval for generic Lacosamide Tablets USP reiterates our ongoing commitment to make treatment options more accessible for patients.
2022-03-01 Alembic Pharmaceuticals Ltd. Regulatory 21st March, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg.
2022-02-02 UCB Pharma Regulatory UCB Receives Positive CHMP Opinion Recommending Approval of BRIVIACT[®] (brivaracetam) and VIMPAT[®] (lacosamide) in the EU for Partial-Onset Seizures in Pediatric Patients From Two to Four Years ucb.com ↗
2020-02-27 Daiichi Sankyo Regulatory Anti-epilepsy Drug VIMPAT ®, Submission for Supplemental Application for Approval in Japan daiichisankyo.com ↗
2019-01-08 Daiichi Sankyo Regulatory Pediatric Dosage and Administration Approved for Anti-epileptic Drug VIMPAT® Tablets 50 mg and 100 mg daiichisankyo.com ↗
VIMPAT® Tablets 50 mg and 100 mg (generic name: lacosamide) has been approved, adding a new dosage and administration regimen for pediatric patients (4 years and older)
2017-09-01 Daiichi Sankyo Regulatory Restriction on prescription period lifted for antiepileptic VIMPAT® Tablets 50 mg and 100 mg daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (headquarters: Chuo-ku, Tokyo; hereafter referred to as “Daiichi Sankyo”) and UCB Japan Co., Ltd. (headquarters: Shinjuku-ku, Tokyo; hereafter referred to as “UCB Japan”; when referring to the global UCB group, “UCB” ) are pleased to announce today that the Ministry of Health, Labor and Welfare issued a notification announcing the lifting of “the 14-day restriction on the prescription period” for the antiepileptic VIMPAT® Tablets 50 mg and 100 mg (generic name: lacosamide).
2017-08-25 Daiichi Sankyo Regulatory Antiepileptic VIMPAT® Tablets 50 mg and 100 mg approved for monotherapy for Partial-onset Seizures in Epilepsy Patients daiichisankyo.com ↗
It had already been approved for partial-onset seizure (including secondary generalized seizures) in adult patients with epilepsy in combination with other agents, as a result of partial amendment of approval, today VIMPAT® was approved for monotherapy.
2016-08-26 Daiichi Sankyo Regulatory Antiepileptic lacosamide filed for partial amendment of approval to add a new indication in Japan daiichisankyo.com ↗
Antiepileptic lacosamide filed for partial amendment of approval to add a new indication in Japan
2016-07-04 Daiichi Sankyo Regulatory 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 ↗
Daiichi Sankyo Company, Limited ("Daiichi Sankyo"; TSE: 4568) and UCB Biopharma SPRL ("UCB") today announced the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for lacosamide (brand name VIMPAT®) as an adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adult patients with epilepsy who have not obtained sufficient response to other antiepileptic drugs.
2015-12-21 Daiichi Sankyo Results Results of Analysis of Data from Clinical Trial of Lacosamide (Generic Name) Announced at 2015 Annual Meeting of the American Epilepsy Society daiichisankyo.com ↗
The study met its primary endpoint for the change in POS frequency per 28 days from baseline to maintenance in the lacosamide 200 mg/day and 400 mg/day.
2015-06-26 Daiichi Sankyo Regulatory Application for Marketing Authorization for Lacosamide (Generic Name) in Japan for the Treatment of Epilepsy daiichisankyo.com ↗
UCB Japan has applied for marketing authorization for lacosamide in Japan as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in patients who have not obtained sufficient response to other antiepileptic drugs.

All press releases naming this drug 18 releases

DateIssuerRelease

Evidence & citations 22 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 ↗
90

“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 ↗

“Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide” NCT07795593 ↗

“long-term administration of Lacosamide” NCT00238511 ↗

NCT02408549 ↗

Show 80 more sources

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)” NCT01243177 ↗

“lacosamide (LCM)” NCT01382017 ↗

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 927” NCT00238511 ↗

NCT00800215 ↗

NCT00135109 ↗

NCT00235469 ↗

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