Brivaracetam
Small molecule targets SV2A
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed simple partial epilepsy 1 milestone | |||||
| Filed | Japan (PMDA) | BRIVIACT | simple partial epilepsy | — | “In July 2023 , UCB submitted the marketing authorization application for the epilepsy medicine BRIVIACT ® (brivaracetam) to PMDA in Japan.” ucb.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 Stop: Enrollment |
| 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 · 1 met primary · 2 missed | ||||||
| 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 Stop: Enrollment |
| 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 | Met primary |
| Phase 2 | NCT00175929 | May 2005 → Mar 2006 | focal epilepsy | UCB Pharma | Completed | Missed primary |
| Phase 2 | NCT00160667 | Oct 2004 → Jan 2006 | postherpetic neuralgia | UCB Pharma | Completed | Missed primary |
| Phase 2 | NCT00401648 | Sep 2002 → Jun 2003 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 326 trials · 4 met primary · 4 missed | ||||||
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00761774 | Nov 2008 → Mar 2017 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00699283 | Aug 2008 → Mar 2010 | epilepsy | UCB Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT00698581 | Aug 2008 → Jan 2010 | epilepsy | UCB Pharma | Terminated | Met primary |
| Phase 3 | NCT00504881 | Oct 2007 → Nov 2008 | epilepsy | UCB Pharma | Completed | Missed primary |
| Phase 3 | NCT00490035 | Sep 2007 → Feb 2009 | epilepsy | UCB Pharma | Completed | Missed primary |
| Phase 3 | NCT00464269 | Sep 2007 → Dec 2008 | epilepsy | UCB Pharma | Completed | Met primary |
| Phase 3 | NCT00357669 | Nov 2006 → Oct 2007 | Unverricht-Lundborg syndrome | UCB Pharma | Completed | Missed primary |
| Phase 3 | NCT00368251 | Nov 2006 → Jan 2008 | Unverricht-Lundborg syndrome | UCB Pharma | Completed | Missed primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT03580707 Comparator | Jun → Dec 2018 | photosensitive epilepsy | Rosenfeld, William E., M.D. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-06-26 | UCB Pharma | Regulatory UCB’s epilepsy drug BRIVIACT[®](brivaracetam)[1] approved in Japan for treatment of focal onset seizures ucb.com ↗
“Today’s approval from the Japanese Ministry of Health, Labor and Welfare is exciting news for those in Japan who are living with epilepsy and need alternative treatment options,” said Kanako Kikuchi, Head of UCB Japan. |
| 2022-10-13 | UCB Pharma | Results UCB announces positive preliminary results for major brivaracetam (Briviact[®]) study in Asia ucb.com ↗
UCB, a global biopharmaceutical company, announced today positive top-line results from the latest Phase 3 study of brivaracetam (Briviact). |
| 2022-02-02 | UCB Pharma | Regulatory UCB Receives Positive CHMP Opinion Recommending Approval of BRIVIACT[®] (brivaracetam) and VIMPAT[®] (lacosamide) in the EU for Partial-Onset Seizures in Pediatric Patients From Two to Four Years ucb.com ↗ |
All press releases naming this drug 3 releases
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 |
| 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 |