Briviact

(Brivaracetam)

ApprovedSmall molecule

Brivaracetam is used to treat a type of seizure disorder called partial-onset seizures, either on its own or combined with other anti-seizure medications.[2] Briviact is currently approved and in use across 12 indications[4].[1]

Briviact is one of 209 small molecule programs targeting Focal impaired awareness seizure. It is currently in Approved.

Indications

Total Trials

Active Trials

208

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Focal Impaired Awareness SeizureActive, not recruiting

Focal-Onset SeizureApproved

Juvenile Absence EpilepsyApproved

Postherpetic NeuralgiaApproved

Brain NeoplasmApproved

Status EpilepticusActive, not recruiting

AdultEnrolling by invitation

Childhood Absence EpilepsyActive, not recruiting

EpilepsyCompleted

GliomaActive, not recruiting

Focal Impaired Awareness SeizureApproved

Active, not recruiting

Focal-Onset SeizureApproved

Approved

Juvenile Absence EpilepsyApproved

Approved

Postherpetic NeuralgiaApproved

Approved

Brain NeoplasmApproved

Approved

Status EpilepticusPreclinical

Active, not recruiting

AdultPhase 1

Enrolling by invitation

Childhood Absence EpilepsyPhase 3

Active, not recruiting

EpilepsyPhase 3

Completed

GliomaPhase 1

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

127 competitors in Adult

#DrugCompanyPhaseTrials

Briviact

UCB

Approved

1 2

Tebrazid

AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Phase 3

1 3

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

1 4

Mounjaro

Eli Lilly

Phase 2

1 5

Rifampicin

Boehringer Ingelheim

Phase 3

3 6

Myqorzo

CCytokinetics

Phase 3

1 7

Opzelura

DDizal Pharmaceuticals

Phase 2

1 8

NM8074

NNovelMed Therapeutics

Phase 2

2 9

EB-1020

Otsuka

Phase 3

1 10

Hytrin

AAbbott

Phase 1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2029

Phase 1/2Not yet recruiting

Alzheimer's Disease

NCT05899764

Q4 2029

Phase 3Active, not recruiting

Childhood Absence Epilepsy

NCT06315322

Q3 2030

Phase 3Recruiting

Epilepsy

NCT04715646

Clinical

Trials by Indication[1]

Epilepsy15 trials

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy

Completed· UCB logo

UCB·Phase 2·NCT03405714·50 enrolled

Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT00504881·480 enrolled

This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

Completed· UCB logo

UCB·Phase 3·NCT00150800·668 enrolled

Show 12 more trials

Comparison of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Epilepsy

Completed·RRESnTEC, Institute of Research·N/A·NCT07163585·102 enrolled

A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil

Completed· UCB logo

UCB·Phase 1·NCT03695094·31 enrolled

Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT00175916·853 enrolled

Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT01364597·257 enrolled

An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.

Completed· UCB logo

UCB·Phase 1·NCT00426673·15 enrolled

A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

Completed· UCB logo

UCB·Phase 2·NCT03021018·46 enrolled

Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT01728077·26 enrolled

A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT03083665·449 enrolled

Compassionate Use Program With Brivaracetam for the Treatment of Patients With Epilepsy

Available· UCB logo

UCB··NCT03532516

Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

Completed· UCB logo

UCB·Phase 2·NCT00422422·100 enrolled

Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT01339559·767 enrolled

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

Recruiting· UCB logo

UCB·Phase 3·NCT04715646·70 enrolled

Seizure11 trials

Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT00490035·399 enrolled

A Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam (BRV) as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Completed· UCB logo

UCB·Phase 3·NCT03685630·10 enrolled

Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT01261325·768 enrolled

Show 8 more trials

A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

Completed· UCB logo

UCB·Phase 2·NCT00175825·210 enrolled

A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Completed· UCB logo

UCB·Phase 3·NCT03250377·207 enrolled

A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Terminated· UCB logo

UCB·Phase 3·NCT00698581·88 enrolled

A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures

Terminated· UCB logo

UCB·Phase 3·NCT03325439·9 enrolled

Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures

Terminated· UCB logo

UCB·Phase 2·NCT02088957·1 enrolled

Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT00464269·400 enrolled

A Study of Brivaracetam in Subjects With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 2·NCT00175929·157 enrolled

A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Terminated· UCB logo

UCB·Phase 3·NCT00699283·62 enrolled

Childhood Absence Epilepsy3 trials

A Study to Test the 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

Completed· UCB logo

UCB·Phase 3·NCT05109234·84 enrolled

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 recruiting· UCB logo

UCB·Phase 3·NCT06315322·70 enrolled

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

Completed· UCB logo

UCB·Phase 3·NCT04666610·153 enrolled

ART2 trials

A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants

Completed· UCB logo

UCB·Phase 1·NCT05315947·24 enrolled

A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants

Completed· UCB logo

UCB·Phase 1·NCT06312566·64 enrolled

Neuropathic Pain1 trial

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

Completed·UUniversity of Minnesota·Phase 3·NCT05639946·44 enrolled

17 more indications

Safety and Efficacy1 trial

An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

Completed· UCB logo

UCB·Phase 3·NCT00761774·108 enrolled

Observational Study1 trial

Brivaracetam: a Prospective and Multicentre Post-marketing Observational Study

Completed·—··NCT03517423·51 enrolled

Drug Interactions1 trial

A Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects

Completed· UCB logo

UCB·Phase 1·NCT01710670·18 enrolled

Side Effects1 trial

Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)

Completed· UCB logo

UCB·Phase 3·NCT01653262·29 enrolled

Tics1 trial

A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects

Completed· UCB logo

UCB·Phase 1·NCT04882540·12 enrolled

Drug1 trial

Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam

Completed· UCB logo

UCB·Phase 1·NCT00736931·20 enrolled

Spinal Cord Injury1 trial

Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

Completed·UUniversity of Minnesota·Phase 1/2·NCT04379011·24 enrolled

Intravenous1 trial

Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy

Completed· UCB logo

UCB·Phase 3·NCT01405508·105 enrolled

Adult1 trial

Bioequivalence Study of Two Brivaracetam Oral Solutions in Healthy Adults Under Fasting and High-Fat Meal Conditions

Enrolling by invitation·JJiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.·Phase 1·NCT06762743·60 enrolled

Status Epilepticus1 trial

Comparison of Intravenous Brivaracetam Versus Levetiracetam in the Management of Status Epilepticus

Completed·MMuhammad Aamir Latif·N/A·NCT07163572·152 enrolled

Fasting Conditions1 trial

An Open Label, Balanced, Randomized, 3×3 Latin Square Design Comparing of Brivaracetam Sustained-release Tablets and Brivaracetam Tablets in the Oral Comparative Pharmacokinetic(PK) Study in Chinese Healthy Adult Subjects Under Fasting Conditions.

Unknown status·OOverseas Pharmaceuticals, Ltd.·Phase 1·NCT05622370·12 enrolled

Unverricht-Lundborg disease1 trial

Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults

Completed· UCB logo

UCB·Phase 3·NCT00357669·50 enrolled

Alzheimer's Disease1 trial

Epileptic Hippocampus in Alzheimer's Disease

Not yet recruiting·UUniversity of California, Los Angeles·Phase 1/2·NCT05899764·25 enrolled

Glioma1 trial

Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas

Active, not recruiting·UUniversity of Rochester·Phase 1·NCT05029960·30 enrolled

Imaging1 trial

A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers

Completed· UCB logo

UCB·Phase 1·NCT02602860·13 enrolled

Neuralgia1 trial

A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)

Completed· UCB logo

UCB·Phase 2·NCT00160667·152 enrolled

Unspecified1 trial

Effect of Brivaracetam in Photosensitive Epileptic Subjects

Completed· UCB logo

UCB·Phase 2·NCT00401648·20 enrolled

Regulatory

FDA Approval Timeline[5]

May 12, 2016

BRIVIACT

NDA NDA205837

May 12, 2016

BRIVIACT

NDA NDA205838

May 12, 2016

BRIVIACT

NDA NDA205836

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Brivaracetam. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Briviact drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Brivaracetam compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Brivaracetam. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA205837). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Briviact. U.S. Food & Drug Administration.
[7]
SEC EDGAR — UCB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Synaptic Vesicle Glycoprotein 2a Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: UCB

Patent Landscape[6]

Patent Cliff

Apr 9, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

6911461Feb 21, 2026

10729653Apr 9, 2030

Briviact

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2029

Q4 2029

Q3 2030

Trials by Indication[1]

Epilepsy15 trials

Seizure11 trials

Childhood Absence Epilepsy3 trials

ART2 trials

Neuropathic Pain1 trial

Safety and Efficacy1 trial

Observational Study1 trial

Drug Interactions1 trial

Side Effects1 trial

Tics1 trial

Drug1 trial

Spinal Cord Injury1 trial

Intravenous1 trial

Adult1 trial

Status Epilepticus1 trial

Fasting Conditions1 trial

Unverricht-Lundborg disease1 trial

Alzheimer's Disease1 trial

Glioma1 trial

Imaging1 trial

Neuralgia1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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