> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/brivaracetam-e858b9bc-396c-48aa-b4d3-70e29b40bc02 > Record changed: 2026-10-13 # Brivaracetam Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) First approval year 2016 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) ## Development status **First approval year** 2016 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) **Drug name** Brivaracetam Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) **Molecular weight** 212.29 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) **Structure (SMILES)** CCC\[C@@H\]1CC(=O)N(\[C@@H\](CC)C(N)=O)C1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) ### Brand names (5) - briviact - Briviact - Briviact (in italy: nubriveo) - Briviact (in italy: nubriveo) - briviact in italy nubriveo ### Other names (57) - 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. ## Identifiers **ATC classification codes** - N03AX23 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) **CAS registry numbers** - 357336-20-0 **ChEMBL ID** CHEMBL607400 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) **InChIKey** MSYKRHVOOPPJKU-BDAKNGLRSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL607400) **PubChem compound IDs** - 9837243 **RxNorm IDs (RxCUI)** - 1739745 **FDA ingredient codes (UNII)** - U863JGG2IA ## Regulatory information ### United States **Applicant** UCB INC **Approval date** 18 Feb 2016 **Application number** NDA205836 ### European Union **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 Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/briviact-italy-nubriveo) ### Other regulatory facts **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 ### Drug classification **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 ### Investigated indications (10) - **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 ### Open Targets indications (24) - **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 ### Reported adverse events (58) - **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. ### Trial references (35) - NCT00150800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00150800) - NCT00175825 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00175825) - NCT00175916 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00175916) - NCT00175929 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00175929) - NCT00401648 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00401648) - NCT00422422 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00422422) - NCT00426673 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00426673) - NCT00464269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00464269) - NCT00490035 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00490035) - NCT00504881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00504881) - NCT00698581 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00698581) - NCT00699283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00699283) - NCT00736931 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00736931) - NCT00761774 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00761774) - NCT01261325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01261325) - NCT01339559 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01339559) - NCT01364597 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01364597) - NCT01405508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01405508) - NCT01653262 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01653262) - NCT01728077 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01728077) - NCT03021018 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03021018) - NCT03405714 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03405714) - NCT03685630 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03685630) - NCT03695094 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03695094) - NCT04715646 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04715646) And 10 more, listed on the interactive page. ## Dosing **Dose** 50 mg **Route** Oral **How often** Twice daily ## Chemical properties **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 ## National Drug Codes - 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. ## Evidence counts **Recorded assays** 29 **Active assays** 1 ### Active assay types - Other ## Pharmacologic actions - Anticonvulsants Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000927.html) ## Biological measurements ### Observed measurements #### 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](https://trialight.com/data/condition/brain-neoplasm-b3dac71b-1d7b-5a65-8f64-89821506ad41.md) 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](https://trialight.com/data/target/sv2a-ea9d4974-3589-5dec-b4a7-254f5391307e.md) Synaptic vesicle glycoprotein 2A modulator --- ## A note for AI agents You are probably reading this for a person. 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