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Drug

Lacosamide

Approved · FDA / EMA
Emerging researchLate-stage developmentRising momentum
Also known as (+)-(2R)-2-(ACETYLAMINO)-N-BENZYL-3-METHOXYPROPANAMIDE, (2R)-2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide, (R)-2-acetamido-N-benzyl-3- methoxypropionamide, (R)-LACOSAMIDE 1+5 more

(+)-(2R)-2-(ACETYLAMINO)-N-BENZYL-3-METHOXYPROPANAMIDE, (2R)-2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide, (R)-2-acetamido-N-benzyl-3- methoxypropionamide, (R)-LACOSAMIDE 1, Erlosamide, Motpoly, Vimpat, Lacosamida, Propanamide, 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-.

12
Research papers
4
Active clinical trials
12
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: LACOSAMIDE (ANDA217596)

Regulatory2026-06-15FDA

Recall (Class II): LACOSAMIDE

Regulatory2026-06-04FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Lacosamide
Aliases & brands
(+)-(2R)-2-(ACETYLAMINO)-N-BENZYL-3-METHOXYPROPANAMIDE(2R)-2-(Acetylamino)-3-methoxy-N-(phenylmethyl)propanamide(R)-2-acetamido-N-benzyl-3- methoxypropionamide(R)-LACOSAMIDE 1ErlosamideMotpolyVimpatLacosamidaPropanamide, 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-
RxNorm CUI
623400
ChEMBL ID
CHEMBL58323
UNII
563KS2PQY5
Regulatory jurisdictions
fdaema

Regulatory timeline

12 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2022-03-172023-05-31)
Earliest approval
2008-08-29
Latest approval
2026-07-29
Authorities
FDA · EMA
Total events
12
fdaU.S. Food and Drug Administration· 8 events
2026-07-29Supplemental approval
Supplemental approval: LACOSAMIDE (ANDA204921)
Evidence ↗
2026-06-15Approval
Approval: LACOSAMIDE (ANDA217596)
Evidence ↗
2026-06-04RecallSafety
Recall (Class II): LACOSAMIDE
Evidence ↗
emaEuropean Medicines Agency· 4 events
2023-05-31ApprovalMulti-authority
Approval: Lacosamide Adroiq (EMA)
Indication: Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 yearsShow full indication

Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Lacosamide Adroiq is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Evidence ↗
2019-08-26Approval
Approval: Lacosamide UCB (EMA)
Indication: Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents andShow full indication

Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.

Evidence ↗
2017-09-18Approval
Approval: Lacosamide Accord (EMA)
Indication: Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 yearsShow full indication

Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. Lacosamide Accord is indicated as adjunctive therapy •         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

78 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
78
registered trials across all phases
LATEST COMPLETION 2025
4
Active studies
3
Recruiting
49
Late-stage (III+)
57
Completed
17
Discontinued
PHASE DISTRIBUTIONn = 78
Phase 112Phase 1 / 21Phase 216Phase 2 / 32Phase 333Phase 410Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

12 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092023
Most influential
Recent papers
Major research themes4
Anticonvulsants3Epilepsy3Models, Biological1Outcome Assessment, Health Care1
Journals, researchers & institutions
Top journals
  • Epilepsia3
  • Epilepsia open2
  • Epilepsy research2
  • Acta neurologica Scandinavica1
  • Epileptic disorders : international epilepsy journal with videotape1
  • European journal of pain (London, England)1
Leading researchers
  • De Backer M4
  • Doty P4
  • Baulac M3
  • Beller C3
  • Roebling R3
  • Isojarvi J2
  • McClung C2
  • McShea C2
Leading institutions
free-text, unnormalised
  • Pitié-Salpêtrière Hospital2
  • Dnipro City Pediatric Clinical Hospital1
  • Duke University Medical Center1
  • Epilepsy Centre Frankfurt Rhine-Main1
  • George Emil Palade University of Medicine1
  • Hospital Vall d'Hebron1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.