Brivaracetam
Small molecule targets SV2A
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | BRIVIACT | — | 2017-09-14 – 2021-08-27 | fda.gov ↗ |
| Approved | US (FDA) | BRIVIACT | — | 2016-02-18 | fda.gov ↗ |
| Approved | EU (EMA) | Briviact (in Italy: Nubriveo) | — | 2016-01-13 | europa.eu ↗ |
Trials 47 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05029960 | May 2022 → May 2024 | brain neoplasm | University of Rochester | Terminated | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT05622370 | Sep 2022 → Mar 2023 | epilepsy | Overseas Pharmaceuticals, Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04882540 | May → Jun 2021 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT03695094 | Sep 2018 → May 2019 | epilepsy | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 1 | NCT02602860 | Nov 2015 → Sep 2017 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01710670 | Sep → Nov 2012 | — | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00736931 | Jul → Oct 2008 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00426673 | Apr 2005 → Jun 2006 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05899764 | Jan 2026 → Jun 2029 expected | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | University of California, Los Angeles | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04379011 | Feb 2021 → Mar 2024 | spinal cord injury | University of Minnesota | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT03405714 | Jun 2018 → Nov 2020 | epilepsy | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 2 | NCT03021018 | Feb 2017 → Apr 2018 | epilepsy | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 2 | NCT02088957 | Mar → Oct 2014 | epilepsy syndrome | UCB BIOSCIENCES, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00422422 | Jul 2011 → Mar 2013 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00175825 | Nov 2005 → Jun 2006 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00175929 | May 2005 → Mar 2006 | focal epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00160667 | Oct 2004 → Jan 2006 | postherpetic neuralgia | UCB Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00401648 | Sep 2002 → Jun 2003 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 326 trials | ||||||
| Phase 3 | NCT06315322 | Jul 2024 → Nov 2029 expected | childhood absence epilepsy, juvenile absence epilepsy | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05639946 | Jan 2023 → Oct 2024 | neuropathy, painful, spinal cord injury | University of Minnesota | Completed | No outcome recorded |
| Phase 3 | NCT05109234 | Mar 2022 → Mar 2025 | childhood absence epilepsy, juvenile absence epilepsy | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT04666610 | Jul 2021 → Aug 2026 overdue | childhood absence epilepsy, juvenile absence epilepsy | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04715646 | Mar 2021 → Jul 2030 expected | epilepsy | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 3 | NCT07563634 | Feb 2021 → May 2024 | focal epilepsy | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03325439 | May 2019 → Sep 2020 | neonatal epilepsy syndrome | UCB Biopharma SRL | Terminated | No outcome recorded |
| Phase 3 | NCT03685630 | Jan 2019 → Mar 2021 | focal epilepsy | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 3 | NCT03083665 | Aug 2017 → Jun 2022 | focal epilepsy | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT03250377 | Aug 2017 → Dec 2024 | focal epilepsy | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT01728077 | Oct 2012 → Aug 2016 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01653262 | Jul 2012 → Nov 2013 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01364597 | Aug 2011 → Feb 2022 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01405508 | Aug 2011 → Jul 2012 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT01339559 | May 2011 → Apr 2019 | epilepsy | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01261325 | Dec 2010 → May 2014 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00761774 | Nov 2008 → Mar 2017 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00698581 | Aug 2008 → Jan 2010 | epilepsy | UCB Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT00699283 | Aug 2008 → Mar 2010 | epilepsy | UCB Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT00504881 | Oct 2007 → Nov 2008 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00490035 | Sep 2007 → Feb 2009 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00464269 | Sep 2007 → Dec 2008 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00368251 | Nov 2006 → Jan 2008 | Unverricht-Lundborg syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00357669 | Nov 2006 → Oct 2007 | Unverricht-Lundborg syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00150800 | Jan 2006 → Sep 2017 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00175916 | Sep 2005 → May 2019 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07163572 | Jan → Aug 2025 | — | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT07163585 | Aug 2024 → Jul 2025 | epilepsy | RESnTEC, Institute of Research | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03532516 | — | epilepsy | UCB Biopharma SRL | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT03580707 Comparator | Jun → Dec 2018 | photosensitive epilepsy | Rosenfeld, William E., M.D. | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Brivaracetam | “Both levetiracetam (LEV) and brivaracetam (BRV) eliminate the electroencephalogram photoparoxysmal response (PPR) in the human phase IIa photosensitivity model of epilepsy.” PMID 32949370 ↗ Oct 202047“Brivaracetam (BRV), a selective, high-affinity ligand for synaptic vesicle protein 2A, is a new antiepileptic drug (AED)” PMID 29486396 ↗ Feb 2018 “Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults” NCT00368251 ↗ |
| Known as | Brivaracetam sustained-release tablets | “Brivaracetam sustained-release tablets Specification: 100mg/ tablet Batch number: 22081201 Content: 102.5% Date of production: August 12, 2022” NCT05622370 ↗ |
| Known as | Brivaracetam tablets | “Brivaracetam tablets (trade name: Briviact) Specification: 50mg/ piece Batch number: 34244 Content: 100.0% Date of purchase: September 2022” NCT05622370 ↗ |
| Known as | BRIVIACT (IN ITALY: NUBRIVEO) | ChEMBL registry synonym — accepted as the source's own label CHEMBL607400 ↗ |
| Known as | Briviact() | “Brivaracetam (Briviact(®)), a 4-n-propyl analogue of levetiracetam developed by UCB Pharma, has been approved in the EU as an adjunctive therapy for the treatment of...” PMID 26899665 ↗ Mar 2016 |
| Known as | BRV | “The purpose of the study is to evaluate the safety and tolerability of intravenous (iv) brivaracetam (BRV) as adjunctive therapy administered as a replacement for oral BRV at...” NCT03685630 ↗21“This long-term open-label extension (OLE) trial was conducted to evaluate the long-term safety and tolerability of brivaracetam (BRV) at individualized doses in patients with...” PMID 33461041 ↗ Dec 2020 “This Compassionate Use Program (CUP) is setup to provide study patients with continuous access to Brivaracetam (BRV) for the time period between closures of the long-term...” NCT03532516 ↗ “This post hoc analysis was conducted to evaluate the efficacy, tolerability, and health-related quality of life during long-term adjunctive brivaracetam (BRV) treatment in...” PMID 34218211 ↗ Jun 2021 “OBJECTIVE: The objective of this analysis was to provide a comprehensive analysis of safety data for adjunctive brivaracetam (BRV), an antiepileptic drug (AED) of the racetam...” PMID 31937513 ↗ Jan 2020 “Brivaracetam (BRV), a selective, high-affinity ligand for synaptic vesicle protein 2A, is a new antiepileptic drug (AED) approved for monotherapy (in the USA) and adjunctive...” PMID 29486396 ↗ Feb 2018 “Brivaracetam (BRV), a selective, high-affinity ligand for synaptic vesicle protein 2A, is a new antiepileptic drug (AED) for adjunctive treatment of focal (partial-onset)...” PMID 28279891 ↗ Feb 2017 “All subjects will receive a single oral dose of Brivaracetam (BRV) 200 mg, given as 50 mg tablets times 4 followed by an adequate volume of water (approximately 200 ml) in 2 of...” NCT01710670 ↗ “This trial evaluated long-term safety, tolerability, and maintenance of efficacy of adjunctive brivaracetam (BRV) in Japanese and Chinese patients aged ≥ 16 years with...” PMID 40549270 ↗ Jun 2025 “PURPOSE: To evaluate the safety and tolerability of adjunctive brivaracetam (BRV), a high-affinity synaptic vesicle protein 2A (SV2A) ligand, in adults with uncontrolled epilepsy.” PMID 24116853 ↗ Oct 2013 “Both levetiracetam (LEV) and brivaracetam (BRV) eliminate the electroencephalogram photoparoxysmal response (PPR) in the human phase IIa photosensitivity model of epilepsy.” PMID 32949370 ↗ Oct 2020 “Brivaracetam (BRV), a selective and high-affinity synaptic vesicle protein 2A ligand, is in development as adjunctive treatment for partial-onset (focal) seizures (POS).” PMID 26471380 ↗ Oct 2015 “Brivaracetam (BRV), a selective, high-affinity ligand for synaptic vesicle 2A (SV2A), has been shown to be useful for the adjunctive treatment of focal seizures.” PMID 27608437 ↗ Sep 2016 “OBJECTIVE: To evaluate the pharmacokinetics, safety, and tolerability of brivaracetam (BRV) as 15-min intravenous (IV) infusion and bolus (≤2-min injection).” PMID 35196395 ↗ Feb 2022 “We evaluated nonpsychotic behavioral adverse events (BAEs) in patients receiving levetiracetam (LEV) who switched to brivaracetam (BRV).” PMID 26432008 ↗ Sep 2015 “Brivaracetam (BRV) and levetiracetam (LEV) are antiepileptic drugs that bind synaptic vesicle glycoprotein 2A (SV2A).” PMID 30924924 ↗ Mar 2019 “adjunctive brivaracetam (BRV), a novel high-affinity synaptic vesicle protein 2A ligand” PMID 22813235 ↗ Jul 2012 “adjunctive brivaracetam (BRV) treatment in pediatric patients with epilepsy” PMID 37597326 ↗ Sep 2023 “Brivaracetam (BRV) is a new anticonvulsant under development.” PMID 20887370 ↗ Sep 2010 “adjunctive brivaracetam (BRV) treatment” PMID 40944847 ↗ Sep 2025 “Brivaracetam (BRV) intravenous (iv)” NCT03325439 ↗ “Brivaracetam (BRV) tablets” NCT01405508 ↗ |
| Known as | ucb 34714 | “Brivaracetam (ucb 34714)” NCT00175916 ↗1“Brivaracetam (ucb34714)” NCT00426673 ↗ |
| Action | Inhibit | “inhibitory activity at neuronal voltage-dependent sodium channels” PMID 22813235 ↗ Jul 2012 |
| Modality | Small molecule | “Brivaracetam (Briviact(®)), a 4-n-propyl analogue of levetiracetam developed by UCB Pharma, has been approved in the EU as an adjunctive therapy for the treatment of...” PMID 26899665 ↗ Mar 2016 |
| Route | Oral | “* Route of Administration: Oral” NCT00150800 ↗ |
| Target | SV2A | “brivaracetam binds to synaptic vesicle glycoprotein 2a (SV2A) in the brain” PMID 26899665 ↗ Mar 2016 |