drugset
Drugs / Anifrolumab
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Anifrolumab

also known as MEDI-546 · Anifrolumab fnia · Saphnelo

Monoclonal antibody targets IFNAR1

Developed for
systemic lupus erythematosus · lupus nephritis · systemic sclerosis · autoimmune disease · cutaneous lupus erythematosus · hidradenitis suppurativa · idiopathic inflammatory myopathy · primary antiphospholipid syndrome
+3 more · rheumatoid arthritis · vitiligo · Sjogren syndrome
Investigated by
AstraZeneca · MedImmune LLC · Parexel · PRA Health Sciences · Aurinia Pharmaceuticals Inc. · Clinigen, Inc.
+12 more · Columbia University · ICON plc · IQVIA Pty Ltd · Josef Smolen, Univ. Prof. Dr. · NYU Langone Health · National and Kapodistrian University of Athens · Oklahoma Medical Research Foundation · PPD Development, LP · Piedmont Heart Institute, Inc., Atlanta, GA · University Hospital, Bordeaux · University of North Carolina, Chapel Hill · Yale University

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Saphnelo — 2022-02-14 europa.eu ↗

Trials 31 · a red edge is where a trial was stopped

today
EU approved 2022
NCT07688980 · Ph 1 NCT07691970 · Ph 3 NCT07630714 · Ph 2 NCT07584083 · Ph 2 NCT07611214 · Ph 4 NCT07430306 · Ph 3 NCT06594068 · Ph 4 NCT06662123 · Ph 1 NCT06015737 · Ph 3 NCT06374212 · Ph 2 NCT06455449 · Ph 3 NCT05835310 · Ph 3 NCT05917561 · Ph 2 NCT05925803 · Ph 3 NCT05339100 · Ph 1 NCT05138133 · Ph 3 NCT05001698 · Ph 1 NCT04877691 · Ph 3 NCT04726553 · Ph 0 NCT03435601 · Ph 2 NCT02962960 · Ph 2 NCT02794285 · Ph 3 NCT02601625 · Ph 1 NCT02547922 · Ph 2 NCT02446899 · Ph 3 NCT02446912 · Ph 3 NCT01753193 · Ph 2 NCT01559090 · Ph 2 NCT01438489 · Ph 2 NCT00930683 · Ph 1
201020112012201320142015201620172018201920202021202220232024202520262027202820292030203120322033
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04726553 Jan 2021 → Dec 2023 systemic lupus erythematosus Oklahoma Medical Research Foundation Unknown No outcome recorded
Phase 16 trials
Phase 1 NCT07688980 Oct 2026 → Apr 2029 expected systemic lupus erythematosus AstraZeneca Not yet recruiting No outcome recorded
Phase 1 NCT06662123 Oct 2024 → Jan 2025 — AstraZeneca Completed No outcome recorded
Phase 1 NCT05339100 Mar 2022 → Apr 2023 — AstraZeneca Completed No outcome recorded
Phase 1 NCT05001698 Jul 2021 → Jun 2022 systemic lupus erythematosus AstraZeneca Completed No outcome recorded
Phase 1 NCT02601625 Nov 2015 → May 2016 — AstraZeneca Completed No outcome recorded
Phase 1 NCT00930683 Sep 2009 → May 2010 systemic sclerosis MedImmune LLC Completed No outcome recorded
Phase 210 trials
Phase 2 NCT07630714 Jul 2026 → Sep 2030 expected systemic lupus erythematosus AstraZeneca Not yet recruiting No outcome recorded
Phase 2 NCT07584083 Apr 2026 → Jun 2028 expected primary antiphospholipid syndrome National and Kapodistrian University of Athens Recruiting No outcome recorded
Phase 2 NCT06374212 Jun 2024 → Jan 2026 overdue hidradenitis suppurativa University of North Carolina, Chapel Hill Active not recruiting No outcome recorded
Phase 2 NCT05917561 Dec 2023 → May 2026 vitiligo University Hospital, Bordeaux Unknown No outcome recorded
Phase 2 NCT03435601 Apr 2018 → Mar 2021 rheumatoid arthritis Josef Smolen, Univ. Prof. Dr. Unknown No outcome recorded
Phase 2 NCT02962960 Feb 2017 → Jan 2018 systemic lupus erythematosus AstraZeneca Completed No outcome recorded
Phase 2 NCT02547922 Nov 2015 → Nov 2019 lupus nephritis AstraZeneca Completed No outcome recorded
Phase 2 NCT01753193 Mar 2013 → Jul 2018 systemic lupus erythematosus MedImmune LLC Completed No outcome recorded
Phase 2 NCT01559090 Apr 2012 → Aug 2014 systemic lupus erythematosus AstraZeneca Completed No outcome recorded
Phase 2 NCT01438489 Jan 2012 → Apr 2015 systemic lupus erythematosus MedImmune LLC Completed No outcome recorded
Phase 311 trials
Phase 3 NCT07691970 Sep 2026 → Dec 2032 expected autoimmune disease AstraZeneca Not yet recruiting No outcome recorded
Phase 3 NCT07430306 Apr 2026 → Jan 2029 expected systemic lupus erythematosus AstraZeneca Recruiting No outcome recorded
Phase 3 NCT06015737 Jun 2024 → Dec 2026 expected cutaneous lupus erythematosus AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT06455449 Jun 2024 → May 2027 expected idiopathic inflammatory myopathy AstraZeneca Recruiting No outcome recorded
Phase 3 NCT05835310 Mar 2024 → Oct 2028 expected systemic lupus erythematosus AstraZeneca Recruiting No outcome recorded
Phase 3 NCT05925803 Nov 2023 → Jan 2027 expected systemic sclerosis AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT05138133 Feb 2022 → Feb 2027 expected lupus nephritis AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT04877691 Jun 2021 → Aug 2025 overdue systemic lupus erythematosus AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT02794285 Jun 2016 → Dec 2021 systemic lupus erythematosus AstraZeneca Completed No outcome recorded
Phase 3 NCT02446899 Jul 2015 → Sep 2018 systemic lupus erythematosus AstraZeneca Completed No outcome recorded
Phase 42 trials
Phase 4 NCT07611214 Apr 2026 → Mar 2029 expected lupus nephritis Aurinia Pharmaceuticals Inc. Recruiting No outcome recorded
Phase 4 NCT06594068 Jan 2026 → Aug 2027 expected systemic lupus erythematosus AstraZeneca Recruiting No outcome recorded
Phase not stated1 trial
— NCT04750057 — systemic lupus erythematosus AstraZeneca No longer available No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT05440422 Comparator Dec 2023 → Aug 2027 expected atherosclerosis, systemic lupus erythematosus National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Recruiting No outcome recorded
Phase 2 NCT05383677 Comparator Oct 2022 → May 2024 Sjogren syndrome University Medical Center Groningen Unknown No outcome recorded
Phase 31 trial
Phase 3 NCT04931563 Comparator Sep 2021 → Apr 2025 systemic lupus erythematosus AstraZeneca Completed No outcome recorded

Press releases naming this drug 6 releases

DateIssuerRelease
2026-04-27 AstraZeneca Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus astrazeneca.com ↗
2026-02-03 AstraZeneca Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus astrazeneca.com ↗
2026-01-06 AstraZeneca Saphnelo self-administration TULIP-SC trial demonstrates statistically significant and clinically meaningful reduction in systemic lupus erythematosus disease activity astrazeneca.com ↗
2025-12-16 AstraZeneca Saphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus astrazeneca.com ↗
2025-10-17 AstraZeneca Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus astrazeneca.com ↗
2025-09-17 AstraZeneca Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis astrazeneca.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 37 sources stand behind the page.

FieldValueCited text
Known as Anifrolumab ClinicalTrials.gov intervention name — accepted as the source's own label NCT04726553 ↗
30

NCT01753193 ↗

NCT05138133 ↗

NCT02962960 ↗

NCT04931563 ↗

NCT06015737 ↗

NCT01438489 ↗

NCT05339100 ↗

NCT02547922 ↗

NCT05440422 ↗

NCT06594068 ↗

NCT07430306 ↗

NCT04750057 ↗

NCT05835310 ↗

NCT05383677 ↗

NCT02794285 ↗

NCT07688980 ↗

NCT07691970 ↗

NCT05917561 ↗

NCT07630714 ↗

NCT07611214 ↗

NCT06374212 ↗

NCT02601625 ↗

NCT03435601 ↗

NCT05001698 ↗

NCT07584083 ↗

NCT05925803 ↗

NCT02446899 ↗

NCT06455449 ↗

NCT06662123 ↗

NCT02446912 ↗
Known as Anifrolumab fnia ChEMBL registry synonym — accepted as the source's own label CHEMBL2364653 ↗
Known as MEDI-546 “The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).” NCT01753193 ↗
3

“intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR)” NCT01559090 ↗

NCT04877691 ↗

NCT00930683 ↗
Known as Saphnelo “Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment” NCT07691970 ↗
Action Inhibit “anifrolumab, a type I interferon (IFN) receptor antagonist” PMID 35157371 ↗ Feb 2022
Modality Monoclonal antibody “MEDI-546 is an investigational human monoclonal antibody directed against the type I IFN receptor.” PMID 24559157 ↗ Feb 2014
Route Intravenous “single and multiple intravenous doses of MEDI-546” NCT00930683 ↗
Target IFNAR1 “a Fully Human Monoclonal Antibody Directed Against Subunit 1 of the Type I Interferon Receptor” NCT00930683 ↗