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levetiracetam

Trade name: keppra

Small moleculeapproved

Approved

Nov 30, 1999

Levetiracetam is an anticonvulsant medication used to treat epilepsy. Levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity. The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. The antiepileptic activity of levetiracetam was assessed in a number of animal models of epileptic seizures. Levetiracetam did not inhibit single seizures induced by maximal stimulation with electrical current or different chemoconvulsants and showed only minimal activity in submaximal stimulation and in threshold tests. Levetiracetam also displayed inhibitory properties in the kindling model in rats, another model of human complex partial seizures, both during kindling development and in the fully kindled state. The predictive value of these animal models for specific types of human epilepsy is uncertain. In vitro and in vivo recordings of epileptiform activity from the hippocampus have shown that levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting that levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity. Levetiracetam at concentrations of up to 10 µM did not demonstrate binding affinity for a variety of known receptors, such as those associated with benzodiazepines, GABA (gamma-aminobutyric acid), glycine, NMDA (Nmethyl-D-aspartate), re-uptake sites, and second messenger systems. Furthermore, in vitro studies have failed to find an effect of levetiracetam on neuronal voltage-gated sodium or T-type calcium currents and levetiracetam does not appear to directly facilitate GABAergic neurotransmission. However, in vitro studies have demonstrated that levetiracetam opposes the activity of negative modulators of GABA- and glycine-gated currents and partially inhibits N-type calcium currents in neuronal cells. A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis. Interaction of levetiracetam with the SV2A protein may contribute to the antiepileptic mechanism of action of the drug. Levetiracetam, along with other anti-epileptic drugs, can increase the risk of suicide behavior or thoughts. People taking levetiracetam should be monitored closely for signs of worsening depression, suicidal thoughts or tendencies, or any altered emotional or behavioral states. — NCATS

Clinical trial activity

239 trials · 209 clinical orgs · 89 marketing orgs

Phase 1
24
Phase 2
130
Phase 3
70
Phase 4
53

Earliest trial started Feb 1, 1998 (NCT00150709)

Timeline

1990s

  1. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

  2. Nov 30, 1999

    UCB — Earliest FDA Approval

  3. Nov 30, 1999

    UCB — NDA Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Dr. Reddy's Laboratories — Earliest Phase 1 Sponsor(trial)

  3. Nov 4, 2008

    Mylan — Marketing Organization

  4. Jan 15, 2009

    Orbion Pharms — Marketing Organization

  5. Jan 15, 2009

    ACI Limited — Marketing Organization

  6. Jan 15, 2009

    Watson Pharmaceuticals — Marketing Organization

  7. Jan 15, 2009

    Wockhardt — Marketing Organization

  8. Jan 15, 2009

    Aurobindo Pharma — Marketing Organization

  9. Jan 15, 2009

    Dr. Reddy's Laboratories — Marketing Organization

  10. Jan 15, 2009

    Fosun — Marketing Organization

  11. Jan 15, 2009

    Invagen Pharms — Marketing Organization

  12. Jan 15, 2009

    Lupin — Marketing Organization

  13. Jan 15, 2009

    Orchid Pharma — Marketing Organization

  14. Jan 15, 2009

    Teva — Marketing Organization

  15. Jan 15, 2009

    Tolmar Inc. — Marketing Organization

  16. Jan 15, 2009

    Torrent Pharmaceuticals Limited — Marketing Organization

  17. Jan 15, 2009

    ANDA Repository — Marketing Organization

  18. Jan 15, 2009

    STALLION LABS — Marketing Organization

  19. Jan 16, 2009

    Esteve Labs — Marketing Organization

  20. Jan 16, 2009

    Bionpharma Inc — Marketing Organization

  21. Feb 10, 2009

    Prinston Inc — Marketing Organization

  22. Feb 10, 2009

    Taro Pharmaceuticals — Marketing Organization

  23. Mar 13, 2009

    Apotex — Marketing Organization

  24. Mar 13, 2009

    Viwit Pharm — Marketing Organization

  25. Mar 20, 2009

    Oxford Pharmaceuticals — Marketing Organization

  26. Apr 3, 2009

    Lannett Company, Inc. — Marketing Organization

  27. Apr 29, 2009

    Zydus Discovery DMCC — Marketing Organization

  28. Oct 27, 2009

    Amneal Pharmaceuticals — Marketing Organization

2010s

  1. Mar 3, 2010

    Xttrium Laboratories — Marketing Organization

  2. May 26, 2010

    Fresenius — Marketing Organization

  3. Jul 28, 2010

    Acic Pharmaceuticals — Marketing Organization

  4. Jul 28, 2010

    VKT Pharma — Marketing Organization

  5. Sep 30, 2010

    Tris Pharma, Inc. — Marketing Organization

  6. Sep 30, 2010

    Belcher Pharmaceuticals — Marketing Organization

  7. Oct 8, 2010

    Hetero Labs Ltd — Marketing Organization

  8. Nov 5, 2010

    Lotus Pharmaceutical — Marketing Organization

  9. Dec 14, 2010

    Vintage — Marketing Organization

  10. Dec 14, 2010

    Jingxin — Marketing Organization

  11. Feb 14, 2011

    Accord Research — Marketing Organization

  12. Jun 14, 2011

    Chartwell Pharmaceuticals — Marketing Organization

  13. Aug 5, 2011

    X Gen Pharmaceuticals — Marketing Organization

  14. Aug 5, 2011

    BEOWULF ASSET — Marketing Organization

  15. Aug 18, 2011

    Nostrum Laboratories — Marketing Organization

  16. Sep 12, 2011

    Actavis — Marketing Organization

  17. Sep 12, 2011

    Virtus Pharms — Marketing Organization

  18. Oct 4, 2011

    Anchen Pharmaceuticals, Inc — Marketing Organization

  19. Oct 4, 2011

    Par Pharmaceuticals — Marketing Organization

  20. Oct 13, 2011

    Hikma — Marketing Organization

  21. Nov 9, 2011

    Hq Speciality Pharma — NDA Secondary Org

  22. Nov 9, 2011

    Hq Speciality Pharma — Marketing Organization

  23. Jan 31, 2012

    Sankyo — Marketing Organization

  24. Jan 31, 2012

    Lutipold — Marketing Organization

  25. Jan 31, 2012

    Daiichi Sankyo — Marketing Organization

  26. Feb 28, 2012

    Hi-Tech Pharmacal — Marketing Organization

  27. Apr 6, 2012

    Hospira — Marketing Organization

  28. Apr 11, 2012

    Genus Oncology, LLC — Marketing Organization

  29. Apr 11, 2012

    Quagen Pharma — Marketing Organization

  30. May 25, 2012

    Pharmadax Inc — Marketing Organization

  31. Aug 27, 2012

    Rouses Point Pharms — Marketing Organization

  32. Nov 1, 2012

    Sandoz — Marketing Organization

  33. Nov 1, 2012

    Novartis — Marketing Organization

  34. May 9, 2013

    Orit Labs Llc — Marketing Organization

  35. May 9, 2013

    Alembic — Marketing Organization

  36. Jun 26, 2013

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  37. Sep 9, 2013

    Sun Pharmaceuticals — Marketing Organization

  38. Jun 4, 2015

    Pharmaceutical Associates — Marketing Organization

  39. Jul 31, 2015

    Aprecia Pharmaceuticals — NDA Secondary Org

  40. Sep 4, 2015

    Dexcel Pharma Technologies Ltd. — Marketing Organization

  41. Sep 4, 2015

    Lachman Consultants — Marketing Organization

  42. Dec 16, 2015

    Secan — Marketing Organization

  43. Feb 1, 2016

    Eugia Pharma — Marketing Organization

  44. Feb 23, 2016

    Intellipharmaceutics — Marketing Organization

  45. Jun 2, 2016

    Jubilant Innovation Ltd. — Marketing Organization

  46. Jun 6, 2016

    Alvogen — Marketing Organization

  47. Aug 26, 2016

    Eci Pharmaceuticals Llc — Marketing Organization

  48. Aug 26, 2016

    Pharma Life Sciences LLC — Marketing Organization

  49. Aug 26, 2016

    AiPing Pharm Inc — Marketing Organization

  50. Sep 28, 2017

    Pharmtak Inc — Marketing Organization

  51. Sep 28, 2017

    Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization

  52. Oct 25, 2017

    Gland Pharma Ltd — Marketing Organization

  53. Mar 20, 2018

    Hainan Poly Pharm — Marketing Organization

  54. May 4, 2018

    Akorn, Inc. — Marketing Organization

  55. Dec 20, 2018

    SPARC — NDA Secondary Org

  56. Dec 20, 2018

    Tripoint — Marketing Organization

  57. Dec 20, 2018

    Tripoint — NDA Secondary Org

  58. Aug 9, 2019

    Micro Labs Ltd India — Marketing Organization

2020s

  1. Jun 11, 2020

    Overseas Pharmaceuticals, Ltd. — Marketing Organization

  2. Jul 6, 2020

    Nexus Pharmaceuticals — Marketing Organization

  3. Nov 27, 2020

    Sciegen Pharmaceticals — Marketing Organization

  4. May 27, 2022

    Alkem Labs Ltd — Marketing Organization

  5. Jul 15, 2022

    MSN Laboratories — Marketing Organization

  6. Jun 13, 2023

    Granules India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 30, 1999

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@@H](C(N)=O)N1C[C@H](C=C(F)F)CC1=O
Mol. weight
232.23 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • (2s)-2-((4s)-4-(2,2-difluoroethenyl)-2-oxopyrrolidin-1-yl)butanamide
  • (2s)-2-((4s)-4-(2,2-difluoroethenyl)-2-oxopyrrolidin-1-yl)butanamide
  • alpha-ethyl-2-oxo-1-pyrrolidineacetamide
  • desitrend
  • etiracetam
  • etiracetam
  • etiracetam, r-isomer
  • etiracetam, s-isomer
  • keppra
  • keppra
  • keppra
  • keppra
  • keppra
  • keppra
  • keppra
  • keppra xr
  • keppra xr
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • levetiracetam
  • (-)-levetiracetam
  • levetiracetame
  • levetiracetame
  • levetiracetam in sodium chloride
  • levetiracetam in sodium chloride
  • levetiracetamum
  • levetiracetamum
  • levitiracetam
  • levitiracetam
  • levroxa
  • matever
  • matever
  • matever
  • seletracetam
  • seletracetam
  • seletracetam
  • seletracetam
  • seletracetam
  • ucb-22059
  • ucb-22059
  • ucb-44212
  • ucb-44212
  • ucb-44212
  • ucb 6474
  • ucb 6474
  • ucb-6474
  • ucb-6474
  • ucb brand of levetiracetam
  • ucb l059
  • ucb-l059
  • ucb-l059
  • ucb-l059
  • ucb l060
  • ucb-l060

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07239115Phase 3Jan 31, 2026Capital Medical University
NCT07284498Phase 4Jan 1, 2026Mansoura University
NCT07220902Phase 3Jan 1, 2026Nebraska Methodist Health System
NCT07234695Phase 3Nov 24, 2025Universidad Autonoma de Madrid, University Hospital Virgen de las Nieves, University of Barcelona, University of Cantabria
NCT07130786Phase 2Sep 30, 2025Harvard University
NCT06907173Phase 3Aug 31, 2025Georgetown University, Harvard University, Medical University of South Carolina, University of Michigan, University of Virginia
NCT07118449Phase 2Aug 27, 2025XyloCor Therapeutics, Inc.
NCT07072624Phase 4Jul 23, 2025All India Institute of Medical Sciences, Indian Council of Medical Research, Postgraduate Institute of Medical Education and Research
NCT07098728N/AJul 22, 2025Government of Myanmar
NCT07046611Phase 2/Phase 3 (Phase 3)Jul 2, 2025Sohag University
NCT06773364Phase 3Apr 30, 2025Fudan University, Huazhong University of Science and Technology
NCT06866691Phase 4Apr 30, 2025Wake Forest University
NCT06919926Phase 2Apr 17, 2025AgeneBio, Johns Hopkins University, National Institute on Aging (NIA)
NCT06851078Phase 3Mar 15, 2025Assistance Publique - Hôpitaux de Paris
NCT07163572N/AJan 16, 2025RESnTEC, Institute of Research
NCT05986721Phase 3Dec 31, 2024AgeneBio
NCT07052136N/ANov 1, 2024RESnTEC, Institute of Research
NCT06345495Phase 2Oct 1, 2024Incyte, University of Texas at Houston
NCT07163585N/AAug 1, 2024RESnTEC, Institute of Research
NCT06442748Phase 3Jul 4, 2024Tata Memorial Hospital
Showing 20 of 239 trials
Page 1 / 12

Organizations

Research & Development (209)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Hoosier Cancer Research NetworkAcademic/Hospital946251998
Harvard UniversityAcademic/Hospital8632003
Johns Hopkins UniversityAcademic/Hospital7622005
University of MinnesotaAcademic/Hospital6432011
MDS PharmaFor profit5022003
National Institute of Neurological Disorders and Stroke (NINDS)Government5132012
Yale UniversityAcademic/Hospital5442005
AgeneBioFor profit4222018
Duke UniversityAcademic/Hospital4422005
National Institute on Aging (NIA)Government4022009
Roxane LaboratoriesFor profit4412005
TevaFor profit4412005
UCBFor profit4232017
University of California, San DiegoAcademic/Hospital4412007
University of California, San FranciscoAcademic/Hospital4322004
University of CincinnatiAcademic/Hospital4442006
Vanderbilt UniversityAcademic/Hospital4422005
National Cancer Institute (NCI)Government3032007
New York UniversityAcademic/Hospital3212009
RESnTEC, Institute of ResearchAcademic/Hospital3312024
209 organizations
Page 1 / 11

Marketing (112)

OrganizationOrg typeRelationshipDate
ACI LimitedFor profitMKTGJan 15, 2009
ACI LimitedFor profitMKTGJan 15, 2009
ANDA RepositoryFor profitMKTGJan 15, 2009
Accord ResearchFor profitMKTGFeb 14, 2011
Acic PharmaceuticalsFor profitMKTGJul 28, 2010
ActavisFor profitMKTGSep 12, 2011
ActavisFor profitSYNMar 2, 2009
ActavisFor profitSYNJan 15, 2009
AiPing Pharm IncFor profitMKTGAug 26, 2016
Akorn, Inc.For profitMKTGMay 4, 2018
AlembicFor profitMKTGMay 9, 2013
AlembicFor profitSYNMay 9, 2013
Alkem Labs LtdFor profitMKTGMay 27, 2022
AlvogenFor profitMKTGJun 6, 2016
Amneal PharmaceuticalsFor profitMKTGOct 27, 2009
Anchen Pharmaceuticals, IncFor profitMKTGOct 4, 2011
ApotexFor profitSYNFeb 25, 2015
ApotexFor profitMKTGMar 13, 2009
Aprecia PharmaceuticalsFor profitNDA2Jul 31, 2015
Aurobindo PharmaFor profitMKTGJan 15, 2009
Aurobindo PharmaFor profitSYNJan 15, 2009
Aurobindo PharmaFor profitSYNDec 19, 2011
BEOWULF ASSETFor profitMKTGAug 5, 2011
Belcher PharmaceuticalsFor profitMKTGSep 30, 2010
Bionpharma IncFor profitMKTGJan 16, 2009
Chartwell PharmaceuticalsFor profitMKTGJun 14, 2011
Chartwell PharmaceuticalsFor profitSYNApr 3, 2009
Daiichi SankyoFor profitMKTGJan 31, 2012
Dexcel Pharma Technologies Ltd.For profitMKTGSep 4, 2015
Dexcel Pharma Technologies Ltd.For profitSYNSep 4, 2015
Dr. Reddy's LaboratoriesFor profitMKTGJan 15, 2009
Eci Pharmaceuticals LlcFor profitMKTGAug 26, 2016
Esteve LabsFor profitMKTGJan 16, 2009
Esteve LabsFor profitSYNJan 16, 2009
Eugia PharmaFor profitMKTGFeb 1, 2016
FosunFor profitMKTGJan 15, 2009
FreseniusFor profitMKTGMay 26, 2010
Genus Oncology, LLCFor profitMKTGApr 11, 2012
Genus Oncology, LLCFor profitSYNAug 26, 2016
Gland Pharma LtdFor profitMKTGOct 25, 2017
Granules IndiaFor profitMKTGJun 13, 2023
Hainan Poly PharmFor profitMKTGMar 20, 2018
Hetero Labs LtdFor profitMKTGOct 8, 2010
Hi-Tech PharmacalFor profitMKTGFeb 28, 2012
HikmaFor profitMKTGOct 13, 2011
HospiraFor profitMKTGApr 6, 2012
Hq Speciality PharmaFor profitNDA2Nov 9, 2011
Hq Speciality PharmaFor profitMKTGNov 9, 2011
IntellipharmaceuticsFor profitMKTGFeb 23, 2016
Invagen PharmsFor profitMKTGJan 15, 2009
JingxinFor profitMKTGDec 14, 2010
Jubilant Innovation Ltd.For profitMKTGJun 2, 2016
Lachman ConsultantsFor profitMKTGSep 4, 2015
Lannett Company, Inc.For profitMKTGApr 3, 2009
Lotus PharmaceuticalFor profitMKTGNov 5, 2010
LupinFor profitMKTGJan 15, 2009
LupinFor profitSYNSep 12, 2011
LutipoldFor profitMKTGJan 31, 2012
MSN LaboratoriesFor profitMKTGJul 15, 2022
Micro Labs Ltd IndiaFor profitMKTGAug 9, 2019
MylanFor profitMKTGNov 4, 2008
MylanFor profitSYNSep 16, 2016
MylanFor profitSYNDec 19, 2011
Nexus PharmaceuticalsFor profitMKTGJul 6, 2020
Nexus PharmaceuticalsFor profitSYNJul 6, 2020
Nostrum LaboratoriesFor profitMKTGAug 18, 2011
NovartisFor profitMKTGNov 1, 2012
Orbion PharmsFor profitMKTGJan 15, 2009
Orchid PharmaFor profitMKTGJan 15, 2009
Orit Labs LlcFor profitMKTGMay 9, 2013
Overseas Pharmaceuticals, Ltd.For profitMKTGJun 11, 2020
Oxford PharmaceuticalsFor profitMKTGMar 20, 2009
Par PharmaceuticalsFor profitMKTGOct 4, 2011
Pharma Life Sciences LLCFor profitMKTGAug 26, 2016
Pharmaceutical AssociatesFor profitMKTGJun 4, 2015
Pharmadax IncFor profitMKTGMay 25, 2012
Pharmtak IncFor profitMKTGSep 28, 2017
Prinston IncFor profitMKTGFeb 10, 2009
Quagen PharmaFor profitMKTGApr 11, 2012
Rouses Point PharmsFor profitMKTGAug 27, 2012
SPARCFor profitNDA2Dec 20, 2018
STALLION LABSFor profitMKTGJan 15, 2009
Sagent Pharmaceuticals, Inc.For profitMKTGJun 26, 2013
SandozFor profitMKTGNov 1, 2012
SankyoFor profitMKTGJan 31, 2012
Sciegen PharmaceticalsFor profitMKTGNov 27, 2020
SecanFor profitMKTGDec 16, 2015
Sun PharmaceuticalsFor profitSYNSep 9, 2013
Sun PharmaceuticalsFor profitMKTGSep 9, 2013
Sun PharmaceuticalsFor profitSYNJun 16, 2010
Sun PharmaceuticalsFor profitSYNSep 12, 2011
Taro PharmaceuticalsFor profitMKTGFeb 10, 2009
TevaFor profitMKTGJan 15, 2009
Tolmar Inc.For profitMKTGJan 15, 2009
Torrent Pharmaceuticals LimitedFor profitSYNMay 29, 2012
Torrent Pharmaceuticals LimitedFor profitMKTGJan 15, 2009
TripointFor profitMKTGDec 20, 2018
TripointFor profitNDA2Dec 20, 2018
Tris Pharma, Inc.For profitMKTGSep 30, 2010
UCBFor profitNDANov 30, 1999
VKT PharmaFor profitMKTGJul 28, 2010
VintageFor profitMKTGDec 14, 2010
Virtus PharmsFor profitMKTGSep 12, 2011
Viwit PharmFor profitMKTGMar 13, 2009
Watson PharmaceuticalsFor profitMKTGJan 15, 2009
WockhardtFor profitMKTGJan 15, 2009
WockhardtFor profitSYNMar 3, 2010
X Gen PharmaceuticalsFor profitMKTGAug 5, 2011
X Gen PharmaceuticalsFor profitSYNAug 5, 2011
Xttrium LaboratoriesFor profitMKTGMar 3, 2010
Zhejiang Hisun Pharmaceutical Co. Ltd.For profitMKTGSep 28, 2017
Zydus Discovery DMCCFor profitMKTGApr 29, 2009