Drugs / Anifrolumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Saphnelo | — | 2022-02-14 | europa.eu ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07630714 | Aug 2026 → Sep 2030 expected | systemic lupus erythematosus | AstraZeneca | 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 | Missed primary |
| 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 | Met primary |
| Phase 312 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT07691970 | Aug 2026 → Dec 2032 expected | autoimmune disease | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT07751848 | Aug 2026 → Aug 2028 expected | systemic lupus erythematosus | AstraZeneca | 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 → Jan 2028 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02446912 | Jun 2015 → Jul 2018 | systemic lupus erythematosus | AstraZeneca | Completed | Missed primary |
| 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 |
| Comparator or background therapy3 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 3 | NCT04931563 Comparator | Sep 2021 → Apr 2025 | systemic lupus erythematosus | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-04-27 | AstraZeneca | Regulatory Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus astrazeneca.com ↗
AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. |
| 2026-02-03 | AstraZeneca | Regulatory Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus astrazeneca.com ↗
The US Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo (anifrolumab) for subcutaneous administration in adult patients with systemic lupus erythematosus (SLE). |
| 2026-01-06 | AstraZeneca | Results Saphnelo self-administration TULIP-SC trial demonstrates statistically significant and clinically meaningful reduction in systemic lupus erythematosus disease activity astrazeneca.com ↗
Positive full results from the Phase III TULIP-SC trial showed the subcutaneous (SC) administration of Saphnelo (anifrolumab) demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo in patients with systemic lupus erythematosus (SLE). |
| 2025-12-16 | AstraZeneca | Regulatory Saphnelo approved in the EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus astrazeneca.com ↗
AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union (EU) for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. |
| 2025-10-17 | AstraZeneca | Regulatory Saphnelo subcutaneous self-administration recommended for approval in EU by CHMP for systemic lupus erythematosus astrazeneca.com ↗
AstraZeneca's Saphnelo (anifrolumab) has been recommended for approval in the European Union (EU) as a self-administered once-weekly pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. |
| 2025-09-17 | AstraZeneca | Results Saphnelo self-administration TULIP-SC Phase III trial meets primary endpoint in patients with systemic lupus erythematosus based on an interim analysis astrazeneca.com ↗
Subcutaneous administration of first-in-class biologic Saphnelo demonstrates statistically significant and clinically meaningful reduction in disease activity |
| 2022-02-16 | AstraZeneca | Regulatory Saphnelo approved in the EU for the treatment of moderate to severe systemic lupus erythematosus astrazeneca.com ↗
AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. |
| 2021-12-20 | AstraZeneca | Regulatory Saphnelo recommended for approval in the EU by CHMP for the treatment of patients with systemic lupus erythematosus astrazeneca.com ↗
AstraZeneca’s Saphnelo (anifrolumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. |
| 2021-09-28 | AstraZeneca | Regulatory Saphnelo approved in Japan for systemic lupus erythematosus astrazeneca.com ↗
AstraZeneca’s Saphnelo (anifrolumab) has been approved in Japan for the treatment of adult patients with systemic lupus erythematosus (SLE), a serious autoimmune disease, who show insufficient response to currently available treatment. |
| 2021-08-02 | AstraZeneca | Regulatory Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus astrazeneca.com ↗
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. |
| 2021-06-02 | AstraZeneca | Results Anifrolumab showed benefit across different measures of skin and joint disease activity in patients with systemic lupus erythematosus astrazeneca.com ↗
For skin rash, the difference in response rates for anifrolumab versus placebo at week 52 were 13.5% SLE Disease Activity Index (SLEDAI), 15.5% British Isles Lupus Assessment Group index (BILAG) and 15.6% modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI). |
| 2019-11-11 | AstraZeneca | Results Anifrolumab demonstrated superiority across multiple efficacy endpoints in patients with systemic lupus erythematosus in Phase III TULIP 2 trial astrazeneca.com ↗
51.5% of anifrolumab patients receiving oral corticosteroids (OCS) greater than or equal to 10mg achieved a sustained reduction in OCS use compared with 30.2% of patients on placebo. |
| 2019-08-29 | AstraZeneca | Results Anifrolumab Phase III trial meets primary endpoint in systemic lupus erythematosus astrazeneca.com ↗
The positive BICLA response in TULIP 2 was consistent with a pre-specified analysis of the previous Phase III TULIP 1 trial, which did not meet its primary endpoint of SLE Responder Index 4 (SRI4). |
| 2018-08-31 | AstraZeneca | Results Update on TULIP 1 Phase III trial for anifrolumab in systemic lupus erythematosus astrazeneca.com ↗
The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE as measured by the SLE Responder Index 4 (SRI4) at 12 months. |
| 2015-11-10 | AstraZeneca | Results AstraZeneca presents positive new data on anifrolumab in lupus at American College of Rheumatology Annual Scientific Meeting astrazeneca.com ↗
Trial results demonstrated that anifrolumab significantly reduced disease activity as measured by several SLE composite endpoints and improved symptoms of lupus such as rash and arthritis. |
All press releases naming this drug 16 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Anifrolumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06455449 ↗ |
| 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 ↗ |
| 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 ↗ |