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Drug

Brivaracetam

Established medicine
ClassSynaptic vesicle glycoprotein 2A modulatorResearchOngoing clinical research

Also known as Briviact.

RxNorm1739745ChEMBLCHEMBL607400ATCN03AX23UNIIU863JGG2IA
19
Research papers
4
Active clinical trials
Synaptic vesicle glycoprotein 2A
Primary target
13
Regulatory events
Latest activity
beta

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

Approval: BRIVARACETAM (ANDA220136)

Regulatory2026-09-08FDA

Approval: BRIVARACETAM (ANDA220288)

Regulatory2026-08-10FDA

A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2 Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Clinical trial2026-08-04Status changed to Completed · ClinicalTrials.gov

Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

Clinical trial2026-07-27Results expected Q3 2030 · ClinicalTrials.gov

Approval: BRIVARACETAM (ANDA219766)

Regulatory2026-07-13FDA

A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY

Clinical trial2026-07-09Results expected Q4 2029 · ClinicalTrials.gov

Approval: BRIVARACETAM (ANDA219952)

Regulatory2026-07-01FDA

Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Clinical trial2026-03-18Results posted · ClinicalTrials.gov

Temporal Profile of Treatment-Emergent Adverse Events in Adult Asian Patients with Focal-Onset Seizures During Adjunctive Brivaracetam Treatment: Post Hoc Analysis of a Phase 3, Randomized Trial.

Research2025-09-13Advances in therapy

Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials.

Research2022-06-10Epilepsia

Pharmacokinetics, safety, and tolerability of intravenous brivaracetam in pediatric patients with epilepsy: An open-label trial.

Research2022-02-23Epilepsia

Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis.

Research2021-06-24Epilepsy research

Profile

Identifiers & mechanism

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

Canonical name
Brivaracetam
Aliases & brands
Briviact
RxNorm CUI
1739745
ChEMBL ID
CHEMBL607400
ATC codes
N03AX23
UNII
U863JGG2IA
Primary mechanism
Synaptic vesicle glycoprotein 2A modulator
Regulatory jurisdictions
fdaema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Synaptic vesicle glycoprotein 2A
SV2A · Q7L0J3
MODULATORSynaptic vesicle glycoprotein 2A modulator

Regulatory timeline

13 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 (2016-01-13 → 2017-09-14)
Earliest approval
2016-01-13
Latest approval
2026-09-08
Authorities
FDA · EMA
Total events
13
fdaU.S. Food and Drug Administration· 12 events
2026-09-08Approval
Approval: BRIVARACETAM (ANDA220136)
Evidence ↗
2026-08-10Approval
Approval: BRIVARACETAM (ANDA220288)
Evidence ↗
2026-07-13Approval
Approval: BRIVARACETAM (ANDA219766)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2016-01-13ApprovalMulti-authority
Approval: Briviact (in Italy: Nubriveo) (EMA)
Indication: Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of… Show full indication

Briviact is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with 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

47 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
47
registered trials across all phases
LATEST COMPLETION 2026
4
Active studies
3
Recruiting
27
Late-stage (III+)
38
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 47
Early Phase 11Phase 19Phase 1 / 22Phase 28Phase 325Phase N / A2

Late-stage studies

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

Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

RecruitingPH IIIUCB Biopharma SRLn=702030

A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY

Active, not recruitingPH IIIUCB Biopharma SRLn=702029

A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2 Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

CompletedPH IIIUCB Biopharma SRLn=1532026

An Open-Label, Multicenter, Long-Term Follow-Up Study to Evaluate the Safety and Sustained Efficacy of Adjunctive Brivaracetam Tablets in Chinese Patients With Uncontrolled Focal Epilepsy

CompletedPH IIIJiangxi Qingfeng Pharmaceutical Co. Ltd.n=1412025

A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

CompletedPH IIIUCB Biopharma SRLn=842025

Recent completions

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

A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2 Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

CompletedPH IIIUCB Biopharma SRLn=1532026

Safety and Efficacy of Intravenous Brivaracetam Versus Levetiracetam in the Management of Status Epilepticus in Children

CompletedN/AMuhammad Aamir Latifn=1522025

Safety and Efficacy of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Children Aged 1 Month to 14 Years With Newly Diagnosed Epilepsy

CompletedN/ARESnTEC, Institute of Researchn=1022025

An Open-Label, Multicenter, Long-Term Follow-Up Study to Evaluate the Safety and Sustained Efficacy of Adjunctive Brivaracetam Tablets in Chinese Patients With Uncontrolled Focal Epilepsy

CompletedPH IIIJiangxi Qingfeng Pharmaceutical Co. Ltd.n=1412025

A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

CompletedPH IIIUCB Biopharma SRLn=842025

An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

CompletedPH IIIUCB Biopharma SRLn=2072024

Research activity

19 papers

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

Publications over time
20142025
Most influential

A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures.

Epilepsia · 2015 · 198 cites

Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial.

Epilepsia · 2014 · 175 cites

Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial.

Epilepsia · 2014 · 122 cites

Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies.

Neurology · 2016 · 95 cites

Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures.

Epilepsia · 2016 · 56 cites

Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study.

Epilepsy research · 2017 · 28 cites
Recent papers

Temporal Profile of Treatment-Emergent Adverse Events in Adult Asian Patients with Focal-Onset Seizures During Adjunctive Brivaracetam Treatment: Post Hoc Analysis of a Phase 3, Randomized Trial.

Advances in therapy · 2025 · 1 cites

Pharmacokinetics, safety, and tolerability of intravenous brivaracetam in pediatric patients with epilepsy: An open-label trial.

Epilepsia · 2022 · 15 cites

Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials.

Epilepsia · 2022 · 6 cites

Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis.

Epilepsy research · 2021 · 7 cites

Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial.

Epilepsia · 2020 · 26 cites

Time course of 75%-100% efficacy response of adjunctive brivaracetam.

Acta neurologica Scandinavica · 2020 · 10 cites
Major research themes6
Anticonvulsants3Quality of Life3Pyrrolidinones2Seizures2Epilepsies, Partial1Epilepsy1
Journals, researchers & institutions
Top journals
  • Epilepsia8
  • Epilepsy research5
  • Epilepsy & behavior : E&B2
  • Acta neurologica Scandinavica1
  • Advances in therapy1
  • Neurology1
Leading researchers
  • Whitesides J9
  • Schiemann J8
  • Elmoufti S7
  • Johnson ME6
  • Klein P6
  • Borghs S4
  • Asadi-Pooya AA3
  • Diaz A3
Leading institutions
free-text, unnormalised
  • Mid-Atlantic Epilepsy and Sleep Center5
  • Bethel Epilepsy Centre2
  • Thomas Jefferson University2
  • University of Cincinnati2
  • University of Melbourne and Royal Melbourne Hospital2
  • Banner University Medical Center1
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.