Febuxostat clinical trials
Febuxostat is named as an intervention in 8 current clinical trials in our China, Japan, Egypt, Australia and South Korea registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Tanta University (2). The most-studied condition is Gout. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Febuxostat is approved
All regulators →Of the three regulators tracked here, the first to approve Febuxostat was the EU, on 21 Apr 2008. It is approved in 3 of the 3 regulators tracked here.
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.
Febuxostat patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Febuxostat, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 8 Sep 2031 (US 8372872).
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 Febuxostat
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 Febuxostat works
All drug targets →- Xanthine dehydrogenase inhibitor InhibitorTarget: XDH xanthine dehydrogenase✓ In ChEMBL and the Guide to Pharmacology
- Endothelial dysfunctionPhase 2/3
- Calcium oxalate nephrolithiasisPhase 2
- AlbuminuriaPhase 2
- Angina pectorisPhase 2
- Chronic kidney diseasePhase 2
- Hypertensive disorderPhase 2
- Kidney disorderPhase 2
- Metabolic dysfunction-associated steatohepatitisPhase 2
- Non-alcoholic fatty liverPhase 2
- Non-small cell lung carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1164729, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6817, 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 Febuxostat
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Febuxostat. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Febuxostat for the management of hyperuricaemia in people with gout NICE TA164 | Recommended | 17 Dec 2008 | 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 Febuxostat
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: Adenuric, Febuxostat Krka (generic), Febuxostat Viatris (previously Febuxostat Mylan) (generic)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 Febuxostat
- ATC code
- M04AA03
- ChEMBL
- CHEMBL1164729
- DrugBank
- DB04854
- PubChem CID
- 134018
- CAS number
- 144060-53-7
- FDA UNII
- 101V0R1N2E
- Wikidata
- Q417296
- Wikipedia
- Febuxostat
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 Febuxostat
8 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.
Febuxostat in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Febuxostat. 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 |
|---|---|---|---|---|
|
Boosting osimertinib Blood Brain Barrier penetration in patients with epidermal growth factor receptor mutated non-small cell lung cancer (OSIBBBOOST)
2025-523033-26-00 · CTIS ↗ · Respiratory Tract Diseases
|
Phase 2 | Authorised | Academisch Ziekenhuis Maastricht | Netherlands |
Febuxostat 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 Febuxostat on the HPRA medicines list.
- Febuxostat Clonmel 120 mg Film-coated tabletsClonmel Healthcare Ltd · PA0126/295/002 · Marketed
- Febuxostat Clonmel 80 mg Film-coated tabletsClonmel Healthcare Ltd · PA0126/295/001 · Marketed
- Febuxostat Rowex 120 mg Film-coated TabletsRowex Limited, · PA0711/273/002 · Marketed
- Febuxostat Rowex 80 mg Film-coated TabletsRowex Limited, · PA0711/273/001 · Marketed
- Adenuric 80 mg film-coated tabletsMenarini International Operations Luxembourg S.A. · EU/1/08/447/001-002
Supply shortages
No entry for Febuxostat in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Febuxostat
10 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Tanta University | 2 |
| Jiangsu HengRui Medicine Co., Ltd | 1 |
| Atom Therapeutics Co., Ltd | 1 |
| Innovent Biologics Technology Limited (Shanghai R&D Center) | 1 |
| Fujita Health University | 1 |
| Saga University | 1 |
| Seoul National University Hospital | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 3 | 2 |
| Clinical trials in Japan | 2 | 2 |
| Clinical trials in Egypt | 2 | 1 |
| Clinical trials in Australia | 1 | 1 |
| Clinical trials in South Korea | 1 | 1 |
| EU register (CTIS) | 1 | — |
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 Febuxostat trials
How many clinical trials are testing Febuxostat?
8 current trials in our China, Japan, Egypt, Australia and South Korea registers name Febuxostat as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Febuxostat trials recruiting patients?
Yes. 6 of the 8 trials are recruiting: 2 with sites in China, 2 with sites in Japan, 1 with sites in Egypt, 1 with sites in Australia 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 Febuxostat clinical trials?
Tanta University (2), Jiangsu HengRui Medicine Co., Ltd (1), Atom Therapeutics Co., Ltd (1) and Innovent Biologics Technology Limited (Shanghai R&D Center) (1), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Febuxostat licensed in Ireland?
Yes. The HPRA medicines list includes 12 single-substance products containing Febuxostat, for example Febuxostat Clonmel 120 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 Febuxostat shortage?
Not in the lists we track: Febuxostat 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 Febuxostat 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 Febuxostat 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 Febuxostat (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.