Etanercept clinical trials
Etanercept is named as an intervention in 10 current clinical trials in our Poland, Canada, USA, China, Germany, Italy, Netherlands, Belgium, Australia, India, Spain, Switzerland, Norway and South Korea registers. 7 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Janssen Research & Development, LLC (1). The most-studied condition is Rheumatoid Arthritis. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Etanercept is approved
All regulators →Of the three regulators tracked here, the first to approve Etanercept was the US, on 2 Nov 1998. It is approved in 3 of the 3 regulators tracked here.
- 2 FDA-approved biosimilars, 1 interchangeable: Erelzi, Eticovo
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.
What health systems spend on Etanercept
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 Etanercept works
All drug targets →- TNF-alpha inhibitor InhibitorTarget: TNF tumor necrosis factorChEMBL only
- AnorexiaPhase 3
- SciaticaPhase 3
- Stevens-Johnson syndromePhase 3
- Acute graft versus host diseasePhase 3
- Chronic kidney diseasePhase 3
- Enthesitis-related juvenile idiopathic arthritisPhase 3
- Extended oligoarticular juvenile idiopathic arthritisPhase 3
- Myocardial ischemiaPhase 3
- Palmoplantar pustulosisPhase 3
- PneumoniaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201572, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6789, 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 Etanercept
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 13 technology appraisals of Etanercept. 9 are current, and 9 of these recommend it for at least some patients. 4 older appraisals were replaced or withdrawn.
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 Etanercept
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 23 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- 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 Etanercept
- ATC code
- L04AB01
- ChEMBL
- CHEMBL1201572
- DrugBank
- DB00005
- CAS number
- 185243-69-0
- FDA UNII
- OP401G7OJC
- Wikidata
- Q415343
- Wikipedia
- Etanercept
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 Etanercept
10 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.
Etanercept in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Etanercept. 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.
Etanercept 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)
23 single-substance products containing Etanercept on the HPRA medicines list.
- Benepali 25 mg solution for injection in pre-filled syringeSamsung Bioepis NL B.V. · EU/1/15/1074/005-007
- Benepali 50 mg solution for injection in pre-filled penSamsung Bioepis NL B.V. · EU/1/15/1074/002
- Benepali 50 mg solution for injection in pre-filled syringeSamsung Bioepis NL B.V. · EU/1/15/1074/001
- Enbrel 10 mg Powder and solvent for solution for injectionPfizer Europe MA EEIG · EU/1/99/126/022
- Enbrel 25 mg Powder for solution for injectionPfizer Europe MA EEIG · EU/1/99/126/001-003
Supply shortages
- EnbrelEU (EMA) · Shortage resolved · first published 19 Feb 2014
Recent approvals
- FubelvEMA · 23 Apr 2026 · biosimilar · Biosimilar Collaborations Ireland Limited
Conditions studied with Etanercept
10 conditionsSponsors
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 Etanercept trials
How many clinical trials are testing Etanercept?
10 current trials in our Poland, Canada, USA, China, Germany, Italy, Netherlands, Belgium, Australia, India, Spain, Switzerland, Norway and South Korea registers name Etanercept as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Etanercept trials recruiting patients?
Yes. 7 of the 10 trials are recruiting: 1 with sites in Poland, 2 with sites in Canada, 2 with sites in China, 1 with sites in Switzerland and 1 with sites in South Korea. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Etanercept clinical trials?
Janssen Research & Development, LLC (1), Sun Pharmaceutical Industries Limited (1), Nanfang Hospital, Southern Medical University (1) and First Affiliated Hospital of Zhejiang University (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Etanercept licensed in Ireland?
Yes. The HPRA medicines list includes 23 single-substance products containing Etanercept, for example Benepali 25 mg solution for injection in pre-filled syringe (Samsung Bioepis NL B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Etanercept shortage?
The registers we track list 1 entry for Etanercept: Enbrel (EU: shortage resolved). 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 Etanercept 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 Etanercept 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 Etanercept (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.