Levetiracetam clinical trials
Levetiracetam is named as an intervention in 14 current clinical trials in our China, Egypt, India, Canada, USA, Spain, Netherlands, Denmark and Mexico registers. 10 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Myrtelle Inc (1). The most-studied condition is Seizures. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Levetiracetam is approved
All regulators →Of the three regulators tracked here, the first to approve Levetiracetam was the US, on 30 Nov 1999. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: medication error for Keppra, 16 Dec 2024
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.
Levetiracetam patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Levetiracetam, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 14 Mar 2034 (US 9339489).
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 Levetiracetam
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 Levetiracetam works
All drug targets →- Synaptic vesicle glycoprotein 2A modulator ModulatorTarget: SV2A synaptic vesicle glycoprotein 2A✓ In ChEMBL and the Guide to Pharmacology
- Voltage-gated N-type calcium channel alpha-1B subunit blocker BlockerTarget: CACNA1B calcium voltage-gated channel subunit alpha1 BChEMBL only
- EncephalopathyPhase 3
- Focal-onset seizurePhase 3
- Generalized non-motor (absence) seizurePhase 3
- Generalized-onset seizurePhase 3
- Alcohol withdrawalPhase 3
- Focal epilepsyPhase 3
- Idiopathic generalized epilepsyPhase 3
- Infantile epileptic encephalopathyPhase 3
- Movement disorderPhase 3
- Status epilepticusPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1286, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6826, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Levetiracetam
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Levetiracetam. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Newer drugs for epilepsy in adults NICE TA76 | Recommended | 24 Mar 2004 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Levetiracetam
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 45 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Keppra, Levetiracetam Accord (generic), Levetiracetam Actavis (generic), Levetiracetam Actavis Group (generic), Levetiracetam Hospira (generic), Levetiracetam Sun (generic), Levetiracetam Teva (generic), Levetiracetam ratiopharm (generic) and 1 moreEMA 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 Levetiracetam
- ATC code
- N03AX14
- ChEMBL
- CHEMBL1286
- DrugBank
- DB01202
- PubChem CID
- 5284583
- CAS number
- 102767-28-2
- FDA UNII
- 44YRR34555
- Wikidata
- Q417227
- Wikipedia
- Levetiracetam
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 Levetiracetam
14 trialsRegisters 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.
Levetiracetam in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Levetiracetam. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Efficacy of prophylactic levetiracetam for improving functional outcome in the acute phase of intracerebral haemorrhage:
a randomised, double-blind, placebo-controlled, phase 3 trial
PEACH 2
2024-515663-59-00 · CTIS ↗ · Nervous System Diseases
|
Phase 3 | Authorised | Hospices Civils De Lyon | France |
Levetiracetam 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)
45 single-substance products containing Levetiracetam on the HPRA medicines list.
- Levetiracetam 100 mg/ml Concentrate for solution for infusionNoridem Enterprises Limited · PA1122/026/001 · Marketed
- Levetiracetam Clonmel 1000 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/326/003 · Marketed
- Levetiracetam Clonmel 250 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/326/001 · Marketed
- Levetiracetam Clonmel 500 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/326/002 · Marketed
- Levetiracetam Thame 100 mg/ml oral solutionSyri Pharma Limited t/a Thame Laboratories · PA22697/012/001 · Marketed
Supply shortages
- Levetiracetam HEXAL 100 mg/ml Konzentrat zur Herstellung einer InfusionslösungGermany (BfArM) · Other reason · 6 Jul 2026 to 20 Nov 2026
- Levetiracetam Holsten 1000 mg FilmtablettenGermany (BfArM) · Production problem · 10 Aug 2026 to 31 Dec 2026
- Levetiracetam Holsten 1000 mg FilmtablettenGermany (BfArM) · Production problem · 10 Aug 2026 to 31 Dec 2026
- LEVETIRACETAM BASICS 500 mg FilmtablettenGermany (BfArM) · Production problem · 14 Jul 2026 to 31 Dec 2026
- LEVETIRACETAM BASICS 500 mg FilmtablettenGermany (BfArM) · Production problem · 14 Jul 2026 to 31 Dec 2026
- LEVETIRACETAM BASICS 1000 mg FilmtablettenGermany (BfArM) · Other reason · 2 Dec 2025 to 31 Dec 2026
+ 14 more German shortage notices.
Conditions studied with Levetiracetam
25 conditionsAll 25 conditions
| Condition (as registered) | Trials |
|---|---|
| Seizures | 2 |
| Canavan Disease | 1 |
| Brain Tumors | 1 |
| Antiepileptics | 1 |
| Levetiracetam | 1 |
| Traumatic Brain Injuries | 1 |
| Traumatic Brain Injury (TBI) Patients | 1 |
| Glioblastoma | 1 |
| Postoperative Seizures After Brain Tumor Surgery | 1 |
| Suspected Stroke | 1 |
| Down Syndrome | 1 |
| Down Syndrome (DS) | 1 |
| Down Syndrome (Trisomy 21) | 1 |
| Alzheimer Dementia | 1 |
| Glioma | 1 |
| Epilepsy | 1 |
| Lactating Women on Select DOI | 1 |
| Breastfed Infants of Mothers on Select DOI | 1 |
| Hippocampal Hyperactivation | 1 |
| Prodromal Alzheimer Disease | 1 |
| Neonatal Seizures | 1 |
| HIE - Hypoxic - Ischemic Encephalopathy | 1 |
| Generalized Convulsive Status Epilepticus | 1 |
| Hypoxic Ischemic Encephalopathy of Newborn | 1 |
| Neuro-protection | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Levetiracetam trials
How many clinical trials are testing Levetiracetam?
14 current trials in our China, Egypt, India, Canada, USA, Spain, Netherlands, Denmark and Mexico registers name Levetiracetam (also registered as [11C]-UCB-J PET-MR scan) as a drug or biological intervention, as of the registry sync on 8 November 2026. Completed and withdrawn studies are not counted.
Are Levetiracetam trials recruiting patients?
Yes. 10 of the 14 trials are recruiting: 2 with sites in China, 1 with sites in Egypt, 2 with sites in India, 2 with sites in Canada, 1 with sites in Spain, 1 with sites in Netherlands, 1 with sites in Denmark and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Levetiracetam clinical trials?
Myrtelle Inc (1), Tata Memorial Centre (1), All India Institute of Medical Sciences, Jodhpur (1) and Tianjin Medical University General Hospital (1), among 14 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Levetiracetam licensed in Ireland?
Yes. The HPRA medicines list includes 45 single-substance products containing Levetiracetam, for example Levetiracetam 100 mg/ml Concentrate for solution for infusion (Noridem Enterprises Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Levetiracetam shortage?
The registers we track list 20 entries for Levetiracetam: 20 German notices. Shortages are product- and country-specific; check with a pharmacist.
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 Levetiracetam 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 Levetiracetam 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 Levetiracetam (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 8 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.