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Drug

Brivaracetam

Approved · FDA / EMA
Emerging researchLate-stage developmentSteady momentum

Also known as Briviact.

RxNorm1739745ChEMBLCHEMBL607400UNIIU863JGG2IA
19
Research papers
5
Active clinical trials
11
Regulatory events
Latest activity
beta

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

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

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 trial2026-03-13Results expected Q3 2026 · ClinicalTrials.gov

Epileptic Hippocampus in Alzheimer's Disease

Clinical trial2026-01-27Results expected Q2 2029 · 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

Label change: BRIVARACETAM (NDA205836)

Regulatory2025-08-28FDA

Label change: BRIVARACETAM (NDA205836)

Regulatory2023-05-17FDA

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
UNII
U863JGG2IA
Regulatory jurisdictions
fdaema

Regulatory timeline

11 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
2026-07-13
Authorities
FDA · EMA
Total events
11
fdaU.S. Food and Drug Administration· 10 events
2026-07-13Approval
Approval: BRIVARACETAM (ANDA219766)
Evidence ↗
2026-07-01Approval
Approval: BRIVARACETAM (ANDA219952)
Evidence ↗
2025-08-28Label change
Label change: BRIVARACETAM (NDA205836)
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 2025
5
Active studies
3
Recruiting
27
Late-stage (III+)
37
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

Active, not recruitingPH 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.

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

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

CompletedPH IIIUniversity of Minnesotan=442024

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.