brivaracetam

Trade name: briviact

Small moleculeapproved

Approved

Feb 18, 2016

Brivaracetam (UCB 34714, trade name Briviact), the 4-n-propyl analog of levetiracetam, is a racetam derivative with anticonvulsant properties. Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. Brivaracetam is believed to act by binding to the ubiquitous synaptic vesicle glycoprotein 2A (SV2A), like levetiracetam, but with 20-fold greater affinity. There is some evidence that racetams including levetiracetam and brivaracetam access the luminal side of recycling synaptic vesicles during vesicular endocytosis. They may reduce excitatory neurotransmitter release and enhance synaptic depression during trains of high-frequency activity, such as is believed to occur during epileptic activity. — NCATS

Clinical trial activity

52 trials · 16 clinical orgs · 9 marketing orgs

Phase 1
15
Phase 2
33
Phase 3
26
Phase 4
0

Earliest trial started Sep 1, 2002 (NCT00401648)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Feb 18, 2016

    UCB — Earliest FDA Approval

  2. Feb 18, 2016

    UCB — NDA Secondary Org

  3. Feb 18, 2016

    UCB — NDA Organization

2020s

  1. Jun 11, 2021

    Zydus Discovery DMCC — Marketing Organization

  2. Aug 13, 2021

    Lupin — Marketing Organization

  3. Apr 20, 2022

    MSN Laboratories — Marketing Organization

  4. Jun 1, 2022

    Annora Pharma — Marketing Organization

  5. Jun 9, 2022

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  6. Jun 13, 2022

    Aurobindo Pharma — Marketing Organization

  7. Jul 12, 2022

    Apotex — Marketing Organization

  8. Aug 12, 2024

    Hainan Poly Pharm — Marketing Organization

Indications

Approved for

Mechanism of action

Approval history

  • approvedFeb 18, 2016

Chemistry & pharmacology

Loading structure…

SMILES

CCC[C@H]1CN([C@@H](CC)C(N)=O)C(=O)C1
Mol. weight
212.2887 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningFirst in class

Sources

Also known as

  • 1-pyrrolidineacetamide, alpha-ethyl-2-oxo-4-propyl-, (alphas,4r)-
  • 2-(2-oxo-4-propylpyrrolidin-1-yl)butanamide
  • (2s)-2-((4r)-2-oxo-4-propylpyrrolidin-1-yl)butanamide
  • bay 59-7939
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • brivaracetam
  • briviact
  • briviact
  • briviact
  • briviact
  • briviact
  • repatoxaban
  • ucb34714
  • ucb 34714
  • ucb 34714
  • ucb-34714
  • ucb-34714
  • ucb-34714
  • ucb-34714
  • xarelto
  • xarelto
  • xarelto
  • xarelto
  • xarelto
  • xarelto

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07163572N/AJan 16, 2025RESnTEC, Institute of Research
NCT06762743Phase 1Oct 21, 2024Government of China, Nanjing University
NCT07163585N/AAug 1, 2024RESnTEC, Institute of Research
NCT06315322Phase 3Jul 10, 2024UCB
NCT06312566Phase 1Mar 25, 2024UCB
NCT05899764Phase 1/Phase 2 (Phase 2)Jun 1, 2023University of California, Los Angeles
NCT05639946Phase 3Jan 1, 2023University of Minnesota
NCT05622370Phase 1Sep 13, 2022Overseas Pharmaceuticals, Ltd.
NCT05315947Phase 1Apr 4, 2022UCB
NCT05109234Phase 3Dec 31, 2021UCB
NCT05029960Early Phase 1 (Phase 1)Dec 31, 2021University of Rochester
NCT04882540Phase 1May 19, 2021UCB
NCT04715646Phase 3Mar 11, 2021UCB
NCT04666610Phase 2/Phase 3 (Phase 3)Dec 31, 2020UCB
NCT04379011Phase 1/Phase 2 (Phase 2)Sep 1, 2020Swedish Hospital, University of Minnesota
NCT03685630Phase 3Oct 31, 2018UCB
NCT03325439Phase 2/Phase 3 (Phase 3)Sep 30, 2018UCB
NCT03695094Phase 1Sep 18, 2018UCB
NCT03580707Phase 2/Phase 3 (Phase 3)Jun 1, 2018Comprehensive Epilepsy Care Center for Children & Adults, Pharmaceutical Research Associates, Inc. (PRA), UCB, Utrecht University
NCT03405714Phase 2Jun 1, 2018UCB
Showing 20 of 52 trials
Page 1 / 3

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Hoosier Cancer Research NetworkAcademic/Hospital282832002
UCBFor profit151442013
Pharmaceutical Research Associates, Inc. (PRA)For profit3032014
RESnTEC, Institute of ResearchAcademic/Hospital2212024
University of MinnesotaAcademic/Hospital2222020
Comprehensive Epilepsy Care Center for Children & AdultsAcademic/Hospital1112018
Genuine Research Center, EgyptFor profit1112015
Government of ChinaGovernment1112024
Horus PharmaFor profit1012015
Nanjing UniversityAcademic/Hospital1012024
Overseas Pharmaceuticals, Ltd.For profit1112022
Swedish HospitalAcademic/Hospital1012020
University of California, Los AngelesAcademic/Hospital1112023
University of RochesterAcademic/Hospital1112021
Utrecht UniversityAcademic/Hospital1012018
Yale UniversityAcademic/Hospital1012015
16 organizations
Page 1 / 1

Marketing (13)

OrganizationOrg typeRelationshipDate
Annora PharmaFor profitMKTGJun 1, 2022
ApotexFor profitMKTGJul 12, 2022
Aurobindo PharmaFor profitMKTGJun 13, 2022
Hainan Poly PharmFor profitMKTGAug 12, 2024
LupinFor profitMKTGAug 13, 2021
MSN LaboratoriesFor profitMKTGApr 20, 2022
MSN LaboratoriesFor profitSYNJun 7, 2022
MSN LaboratoriesFor profitSYNNov 13, 2025
Sunshine Lake Pharma Co., Ltd.For profitMKTGJun 9, 2022
UCBFor profitNDA2Feb 18, 2016
UCBFor profitNDAFeb 18, 2016
Zydus Discovery DMCCFor profitSYNOct 3, 2022
Zydus Discovery DMCCFor profitMKTGJun 11, 2021