Brivaracetam clinical trials
Brivaracetam is named as an intervention in 2 current clinical trials in our USA, Italy, Germany, France, Spain, Belgium, Poland, Czechia, Mexico and Japan registers. 1 is recruiting patients now. All registered phases are Phase 3. The lead sponsor is UCB Biopharma SRL. The most-studied condition is Epilepsy.
Where Brivaracetam is approved
All regulators →Of the three regulators tracked here, the first to approve Brivaracetam was the EU, on 13 Jan 2016. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: quality defect for Briviact (in Italy: Nubriveo), 18 Dec 2021
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Brivaracetam patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Brivaracetam, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 1 listed patent; the last listed expires 9 Apr 2030 (US 10729653).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Brivaracetam
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Brivaracetam works
All drug targets →- Synaptic vesicle glycoprotein 2A modulator ModulatorTarget: SV2A synaptic vesicle glycoprotein 2A✓ In ChEMBL and the Guide to Pharmacology
- Focal-onset seizurePhase 3
- Generalized-onset seizurePhase 3
- MyoclonusPhase 3
- PainPhase 3
- Unverricht-Lundborg syndromePhase 3
- Childhood absence epilepsyPhase 3
- Focal epilepsyPhase 3
- Juvenile absence epilepsyPhase 3
- Neuropathic painPhase 3
- Spinal cord injuryPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL607400, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9041, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Brivaracetam
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 12 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Briviact (in Italy: Nubriveo)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Brivaracetam
- ATC code
- N03AX23
- ChEMBL
- CHEMBL607400
- DrugBank
- DB05541
- PubChem CID
- 9837243
- CAS number
- 357336-20-0
- FDA UNII
- U863JGG2IA
- Wikidata
- Q408099
- Wikipedia
- Brivaracetam
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Brivaracetam
2 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
NCT04715646 · Epilepsy
|
Phase 3 | Recruiting | UCB Biopharma SRL | USA, Germany, France, Spain, Italy, Belgium, Poland, Czechia, Mexico, Japan |
|
A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
NCT06315322 · Childhood Absence Epilepsy, Juvenile Absence Epilepsy
|
Phase 3 | Active, closed | UCB Biopharma SRL | USA, Italy |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Brivaracetam across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
12 single-substance products containing Brivaracetam on the HPRA medicines list.
- Brivaracetam Clonmel 10 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/403/001 · Marketed
- Brivaracetam Clonmel 100 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/403/005 · Marketed
- Brivaracetam Clonmel 25 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/403/002 · Marketed
- Brivaracetam Clonmel 50 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/403/003 · Marketed
- Brivaracetam Clonmel 75 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/403/004 · Marketed
Supply shortages
No entry for Brivaracetam in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Brivaracetam
3 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| UCB Biopharma SRL | 2 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Brivaracetam trials
How many clinical trials are testing Brivaracetam?
2 current trials in our USA, Italy, Germany, France, Spain, Belgium, Poland, Czechia, Mexico and Japan registers name Brivaracetam as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Brivaracetam trials recruiting patients?
Yes. 1 of the 2 trials is recruiting: 1 with sites in USA, 1 with sites in Italy, 1 with sites in Germany, 1 with sites in France, 1 with sites in Spain, 1 with sites in Belgium, 1 with sites in Poland, 1 with sites in Czechia, 1 with sites in Mexico and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Brivaracetam clinical trials?
The lead sponsor is UCB Biopharma SRL. The number in brackets is how many trials each organisation leads.
Is Brivaracetam licensed in Ireland?
Yes. The HPRA medicines list includes 12 single-substance products containing Brivaracetam, for example Brivaracetam Clonmel 10 mg film-coated tablets (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Brivaracetam shortage?
Not in the lists we track: Brivaracetam has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Brivaracetam works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Brivaracetam works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Brivaracetam (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.