Anifrolumab clinical trials
Anifrolumab is named as an intervention in 13 current clinical trials in our USA, Germany, Poland, France, Spain, Italy, Mexico, China, Japan, UK, Turkey, Canada, Brazil, Taiwan, India, Netherlands, Belgium, Portugal, Austria, Czechia, South Korea, Australia, Israel, Denmark and Sweden registers. 10 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is AstraZeneca (12). The most-studied condition is Systemic Lupus Erythematosus. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Anifrolumab is approved
All regulators →Of the three regulators tracked here, the first to approve Anifrolumab was the US, on 30 Jul 2021. 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.
What health systems spend on Anifrolumab
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 Anifrolumab works
All drug targets →- Interferon-alpha/beta receptor alpha chain antagonist AntagonistTarget: IFNAR1 interferon alpha and beta receptor subunit 1✓ In ChEMBL and the Guide to Pharmacology
- Cutaneous lupus erythematosusPhase 3
- DermatomyositisPhase 3
- Lupus nephritisPhase 3
- PolymyositisPhase 3
- Systemic sclerosisPhase 3
- Antiphospholipid syndromePhase 2
- Hidradenitis suppurativaPhase 2
- Ovarian cancerPhase 2
- Rheumatoid arthritisPhase 2
- VitiligoPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2364653, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8258, 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 Anifrolumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Anifrolumab. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Anifrolumab for treating active autoantibody-positive systemic lupus erythematosus (terminated appraisal) NICE TA793 | Terminated (no company submission) | 8 Jun 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 Anifrolumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: SaphneloEMA 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.
Trials by status
Trials by phase
Clinical trials of Anifrolumab
13 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.
Anifrolumab in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Anifrolumab. 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 |
|---|---|---|---|---|
|
ROSY-S: Rollover Study for Participants Who have Completed a Previous Study with Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment
2026-526419-13-00 · CTIS ↗ · Musculoskeletal Diseases
|
Phase 3 | Authorised | AstraZeneca AB | Netherlands, Belgium, Bulgaria + 10 more |
|
A Multicenter, Open-Label, Phase II Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Systemic Lupus Erythematosus.
2025-524578-41-00 · Immune System Diseases
|
Phase 2 | Ongoing | AstraZeneca AB | Belgium, Portugal, Netherlands |
|
A Phase II Open-Label Pilot Trial Assessing the Safety of Anifrolumab in Adult Patients with Primary Antiphospholipid Syndrome (APS). The AnifAPS trial.
2025-520918-64-00 · CTIS ↗ · Immune System Diseases
|
Phase 2 | Ongoing | National And Kapodistrian University Of Athens | Greece |
Anifrolumab 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)
3 single-substance products containing Anifrolumab on the HPRA medicines list.
- Saphnelo 120 mg solution for injection in pre-filled penAstraZeneca AB · EU/1/21/1623/003-005
- Saphnelo 120 mg solution for injection in pre-filled syringeAstraZeneca AB · EU/1/21/1623/002
- Saphnelo 300 mg Concentrate for solution for infusionAstraZeneca AB · EU/1/21/1623/001
Supply shortages
No entry for Anifrolumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Anifrolumab
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| AstraZeneca | 12 |
| Aurinia Pharmaceuticals Inc | 1 |
By 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 Anifrolumab trials
How many clinical trials are testing Anifrolumab?
13 current trials in our USA, Germany, Poland, France, Spain, Italy, Mexico, China, Japan, UK, Turkey, Canada, Brazil, Taiwan, India, Netherlands, Belgium, Portugal, Austria, Czechia, South Korea, Australia, Israel, Denmark and Sweden registers name Anifrolumab (also registered as Medi-546) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Anifrolumab trials recruiting patients?
Yes. 10 of the 13 trials are recruiting: 6 with sites in USA, 4 with sites in Germany, 3 with sites in Poland, 4 with sites in France, 4 with sites in Spain, 4 with sites in Italy, 3 with sites in Mexico, 3 with sites in China, 2 with sites in Japan, 2 with sites in UK, 2 with sites in Turkey, 3 with sites in Canada, 2 with sites in Brazil, 2 with sites in Taiwan, 1 with sites in India, 1 with sites in Netherlands, 1 with sites in Belgium, 2 with sites in Portugal, 1 with sites in Austria, 1 with sites in Czechia, 1 with sites in South Korea, 1 with sites in Australia, 1 with sites in Israel, 1 with sites in Denmark and 1 with sites in Sweden. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Anifrolumab clinical trials?
AstraZeneca (12) and Aurinia Pharmaceuticals Inc (1). The number in brackets is how many trials each organisation leads.
Is Anifrolumab licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Anifrolumab, for example Saphnelo 120 mg solution for injection in pre-filled pen (AstraZeneca AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Anifrolumab shortage?
Not in the lists we track: Anifrolumab 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 Anifrolumab 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 Anifrolumab 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 Anifrolumab (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.