Brivaracetam
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2016
- First approval year
- 2016
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Brivaracetam
- Molecular weight
- 212.29
- Structure (SMILES)
- CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
- briviact
- Briviact
- Briviact (in italy: nubriveo)
- Briviact (in italy: nubriveo)
- briviact in italy nubriveo
- britzilam sr brivaracetam sustained release tablets 200 mg
- brivaracetam
- Brivaracetam
- BRIVARACETAM
- Brivaracetam (BRV)
- Brivaracetam (BRV) intravenous (iv)
- Brivaracetam (BRV) oral
- brivaracetam (BRV) tablet
- Brivaracetam (ucb 34714)
- Brivaracetam (ucb34714)
- Brivaracetam [EP MONOGRAPH]
- brivaracetam [INN]
- BRIVARACETAM [JAN]
- BRIVARACETAM [MART.]
- BRIVARACETAM [MI]
- BRIVARACETAM [ORANGE BOOK]
- BRIVARACETAM [USAN]
- Brivaracetam [WHO-DD]
- Brivaracetam 10 mg
- Brivaracetam 10 mg oral tablet
- Brivaracetam 100 mg oral tablet
- Brivaracetam 2.5 mg
- Brivaracetam 25 mg
- Brivaracetam 50 mg
- Brivaracetam 50 mg oral tablet
And 32 more, listed on the interactive page.
- ATC classification codes
- N03AX23
Sources for recorded values
- CAS registry numbers
- 357336-20-0
- ChEMBL ID
- CHEMBL607400
- InChIKey
- MSYKRHVOOPPJKU-BDAKNGLRSA-N
- PubChem compound IDs
- 9837243
- RxNorm IDs (RxCUI)
- 1739745
- FDA ingredient codes (UNII)
- U863JGG2IA
- Applicant
- UCB INC
- Approval date
- 18 Feb 2016
- Application number
- NDA205836
- Status
- Authorised
- Status date
- 13 Jan 2016
- Authorisation date
- 13 Jan 2016
- Approved indications
- 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.
- Product number
- EMEA/H/C/003898
- Authorisation holder
- UCB Pharma SA
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Epilepsy
European medicines record
- Patents
- 4
- Designations
- 1
- Earliest recorded loss of exclusivity
- 9 Apr 2030
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- brivaracetam
- Type
- Synthetic organic
- Drug name stem
- -racetam
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
Mechanisms of action
- Mechanism
- Synaptic vesicle glycoprotein 2A modulator
- Action type
- MODULATOR
- Target
- Synaptic vesicle glycoprotein 2A
- Protein identifier
- Q7L0J3
Open Targets mechanisms
- Mechanism
- Synaptic vesicle glycoprotein 2A modulator
- Action type
- MODULATOR
- Target
- Synaptic vesicle glycoprotein 2A
DrugCentral mechanisms
- Action type
- MODULATOR
- Gene symbol
- SV2A
- Protein identifier
- Q7L0J3
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Epilepsy
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000474
- Subject identifier
- D004827
- Condition
- Brain Neoplasms
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0003833
- Subject identifier
- D001932
- Condition
- Spinal Cord Injuries
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001919
- Subject identifier
- D013119
- Condition
- Epilepsy
- Highest recorded phase
- 4
- Condition identifier
- HP:0001250
- Subject identifier
- D004827
- Condition
- Seizures
- Highest recorded phase
- 4
- Condition identifier
- HP:0001250
- Subject identifier
- D012640
- Condition
- Seizures
- Highest recorded phase
- 4
- Condition identifier
- HP:0007359
- Subject identifier
- D012640
- Condition
- Epilepsy, Absence
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0010826
- Subject identifier
- D004832
- Condition
- Neuralgia, Postherpetic
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0041052
- Subject identifier
- D051474
- Condition
- Epilepsy, Absence
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0800453
- Subject identifier
- D004832
- Condition
- Unverricht-Lundborg Syndrome
- Highest recorded phase
- 3
- Condition identifier
- Orphanet:308
- Subject identifier
- D020194
- Condition identifier
- EFO_0000474
- Condition identifier
- EFO_0003833
- Condition identifier
- EFO_0005762
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008526
- Condition identifier
- HP_0001250
- Condition identifier
- HP_0001250
- Highest recorded phase
- 4
- Condition identifier
- HP_0001336
- Highest recorded phase
- 3
- Condition identifier
- HP_0002197
- Highest recorded phase
- 3
- Condition identifier
- HP_0002384
- Condition identifier
- HP_0002384
- Highest recorded phase
- 4
- Condition identifier
- HP_0007359
- Highest recorded phase
- 1
- Condition identifier
- HP_0007359
- Highest recorded phase
- 3
- Condition identifier
- HP_0012531
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004975
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005027
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005384
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0010826
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0015643
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0021211
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0041052
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0043797
- Condition identifier
- MONDO_0043797
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0800453
- Highest recorded phase
- 3
- Condition identifier
- Orphanet_308
- Highest recorded phase
- 3
- Event
- abnormal behaviour
- Reports
- 21
- Reporting signal score
- 26.7955
- Event
- affective disorder
- Reports
- 15
- Reporting signal score
- 37.7191
- Event
- aggression
- Reports
- 72
- Reporting signal score
- 159.29
- Event
- anger
- Reports
- 19
- Reporting signal score
- 31.7371
- Event
- anxiety
- Reports
- 42
- Reporting signal score
- 25.1363
- Event
- anxiety disorder
- Reports
- 7
- Reporting signal score
- 18.1887
- Event
- arthralgia
- Reports
- 1
- Reporting signal score
- 16.5132
- Event
- atonic seizures
- Reports
- 7
- Reporting signal score
- 27.2052
- Event
- aura
- Reports
- 16
- Reporting signal score
- 64.7398
- Event
- balance disorder
- Reports
- 20
- Reporting signal score
- 16.5868
- Event
- behaviour disorder
- Reports
- 21
- Reporting signal score
- 74.3062
- Event
- brain operation
- Reports
- 6
- Reporting signal score
- 21.1818
- Event
- carbon monoxide poisoning
- Reports
- 3
- Reporting signal score
- 12.6131
- Event
- change in seizure presentation
- Reports
- 5
- Reporting signal score
- 20.8715
- Event
- deja vu
- Reports
- 3
- Reporting signal score
- 13.1719
- Event
- depression
- Reports
- 71
- Reporting signal score
- 73.9545
- Event
- diarrhoea
- Reports
- 10
- Reporting signal score
- 13.3141
- Event
- dizziness
- Reports
- 76
- Reporting signal score
- 31.7699
- Event
- drug level fluctuating
- Reports
- 4
- Reporting signal score
- 12.0275
- Event
- dystonia
- Reports
- 10
- Reporting signal score
- 12.4275
- Event
- epilepsy
- Reports
- 25
- Reporting signal score
- 36.491
- Event
- fatigue
- Reports
- 74
- Reporting signal score
- 13.8217
- Event
- feeling drunk
- Reports
- 6
- Reporting signal score
- 11.807
- Event
- focal dyscognitive seizures
- Reports
- 20
- Reporting signal score
- 95.3588
- Event
- generalised tonic-clonic seizure
- Reports
- 72
- Reporting signal score
- 221.351
And 33 more, listed on the interactive page.
- NCT00150800
- NCT00175825
- NCT00175916
- NCT00175929
- NCT00401648
- NCT00422422
- NCT00426673
- NCT00464269
- NCT00490035
- NCT00504881
- NCT00698581
- NCT00699283
- NCT00736931
- NCT00761774
- NCT01261325
- NCT01339559
- NCT01364597
- NCT01405508
- NCT01653262
- NCT01728077
- NCT03021018
- NCT03405714
- NCT03685630
- NCT03695094
- NCT04715646
And 10 more, listed on the interactive page.
- Dose
- 50 mg
- Route
- Oral
- How often
- Twice daily
- Hydrogen bond acceptors
- 2
- Hydrogen bond donors
- 1
- Polar surface area
- 63.4
- Calculated partition coefficient (ALogP)
- 0.9
- Calculated partition coefficient (XLogP)
- 1
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 5
- Heavy atoms
- 15
- Molecular formula
- C11H20N2O2
- Monoisotopic mass
- 212.152477885
- Natural product
- Yes
- 0121-1074
- 0121-1075
- 14335-420
- 42571-370
- 50228-556
- 50228-557
- 50228-558
- 50228-559
- 50228-560
- 50474-370
- 50474-470
- 50474-570
- 50474-670
- 50474-770
- 50474-870
- 50474-970
- 59651-995
- 67877-904
- 70748-411
- 71921-410
- 72205-033
- 72205-267
- 72205-268
- 72205-269
- 72205-270
And 37 more, listed on the interactive page.
- Recorded assays
- 29
- Active assays
- 1
Active assay types
- Other
- Anticonvulsants
Oral bioavailability
- Median
- 100
- Mean
- 100
- Minimum
- 100
- Maximum
- 100
- Unit
- %
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (80)
- A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
- A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants
- 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
- A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
- 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
- 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
- A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia)
- A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body
- A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil
- A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects
- A Study of Brivaracetam in Subjects With Partial Onset Seizures
- A Study of LY3337641 in Healthy Participants
- A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761
- A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants
- A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
- A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
- A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
- A Study to Compare Blood Levels of Different Dosage Formulations of the Study Medicine That Is a CGRP Receptor Antagonist in Healthy Adults
- A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy Adults
- A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Approved for (2)
- Epilepsy
- Visual epilepsy
In development for (6)
- Brain neoplasm Early phase 1
- Childhood absence epilepsy Phase 3
- Juvenile absence epilepsy Phase 3
- Postherpetic neuralgia Phase 2
- Spinal cord injury Phase 1
- Unverricht-Lundborg syndrome Phase 3
Targets (1)
- SV2A Synaptic vesicle glycoprotein 2A modulator