Roxadustat clinical trials
Roxadustat is named as an intervention in 7 current clinical trials in our China, Sweden, Egypt, Ireland, UK, Germany, Spain, Italy, Netherlands, Belgium, Denmark, Poland, Norway and Turkey registers. 2 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Mansoura University (2). The most-studied condition is Anemia in End Stage Renal Disease.
Where Roxadustat is approved
All regulators →Of the three regulators tracked here, the first to approve Roxadustat was the EU, on 18 Aug 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.
What health systems spend on Roxadustat
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 Roxadustat works
All drug targets →- Hypoxia-inducible factor prolyl hydroxylase inhibitor InhibitorTarget: Hypoxia-inducible factor prolyl hydroxylase✓ In ChEMBL and the Guide to Pharmacology
- Kidney disorderPhase 3
- Myelodysplastic syndromePhase 3
- Stage 5 chronic kidney diseasePhase 3
- Diabetic kidney diseasePhase 2
- Abnormal mineralization disorderPhase 1/2
- AnxietyPhase 1/2
- Cardiovascular disorderPhase 1/2
- Depressive disorderPhase 1/2
- Major depressive disorderPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2338329, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8454, 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 Roxadustat
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Roxadustat. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Roxadustat for treating symptomatic anaemia in chronic kidney disease NICE TA807 | Optimised | 13 Jul 2022 | 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 Roxadustat
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 5 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: EvrenzoEMA 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 Roxadustat
- ATC code
- B03XA05
- ChEMBL
- CHEMBL2338329
- DrugBank
- DB04847
- PubChem CID
- 11256664
- CAS number
- 808118-40-3
- FDA UNII
- X3O30D9YMX
- Wikidata
- Q27088611
- Wikipedia
- Roxadustat
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 Roxadustat
7 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.
Roxadustat 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)
5 single-substance products containing Roxadustat on the HPRA medicines list.
- Evrenzo 100 mg Film-coated tabletAstellas Pharma Europe B.V. · EU/1/21/1574/004
- Evrenzo 150 mg Film-coated tabletAstellas Pharma Europe B.V. · EU/1/21/1574/005
- Evrenzo 20 mg Film-coated tabletAstellas Pharma Europe B.V. · EU/1/21/1574/001
- Evrenzo 50 mg Film-coated tabletAstellas Pharma Europe B.V. · EU/1/21/1574/002
- Evrenzo 70 mg Film-coated tabletAstellas Pharma Europe B.V. · EU/1/21/1574/003
Supply shortages
No entry for Roxadustat in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Roxadustat
18 conditionsAll 18 conditions
| Condition (as registered) | Trials |
|---|---|
| Anemia in End Stage Renal Disease | 2 |
| Chronic Kidney Disease | 1 |
| Renal Anemia | 1 |
| Perioperative Anemia | 1 |
| Heart Failure | 1 |
| CKD | 1 |
| Anemia | 1 |
| Coronary Artery Disease | 1 |
| Coronary Artery Bypass Grafting | 1 |
| Hypoxia-Inducible Factor 1, Alpha Subunit | 1 |
| Prolyl-Hydroxylase Inhibitors | 1 |
| Diabetes Complications | 1 |
| Diabetes; Nephropathy (Manifestation) | 1 |
| Kidney Failure, Chronic | 1 |
| Malnutrition-Inflammation Syndrome | 1 |
| Cardiovascular Diseases (CVD) | 1 |
| Kidney Failure,Chronic | 1 |
| Depression Anxiety Disorder | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Roxadustat trials
How many clinical trials are testing Roxadustat?
7 current trials in our China, Sweden, Egypt, Ireland, UK, Germany, Spain, Italy, Netherlands, Belgium, Denmark, Poland, Norway and Turkey registers name Roxadustat (also registered as ASP1517) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Roxadustat trials recruiting patients?
Yes. 2 of the 7 trials are recruiting: 2 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Roxadustat clinical trials?
Mansoura University (2), Astellas Pharma Global Development, Inc (1), Second Affiliated Hospital, Zhejiang University, School of Medicine (1) and Zhongda Hospital (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Roxadustat clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Roxadustat licensed in Ireland?
Yes. The HPRA medicines list includes 5 single-substance products containing Roxadustat, for example Evrenzo 100 mg Film-coated tablet (Astellas Pharma Europe B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Roxadustat shortage?
Not in the lists we track: Roxadustat 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 Roxadustat 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 Roxadustat 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 Roxadustat (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.