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Drug

Anifrolumab

Approved · EMA
ClassInterferon-alpha/beta receptor alpha chain antagonistEmerging researchLate-stage development

Also known as Saphnelo.

RxNorm2565265ChEMBLCHEMBL2364653ATCL04AG11UNII38RL9AE51Q
1
Research papers
9
Active clinical trials
Interferon alpha/beta receptor 1
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy

Clinical trial2026-07-17Results expected Q4 2028 · ClinicalTrials.gov

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

Clinical trial2026-07-09Results expected Q4 2032 · ClinicalTrials.gov

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

Clinical trial2026-06-29Results expected Q1 2029 · ClinicalTrials.gov

A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared With Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive With Systemic Sclerosis

Clinical trial2026-06-26Results expected Q1 2027 · ClinicalTrials.gov

PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab

Clinical trial2026-06-26Results expected Q3 2027 · ClinicalTrials.gov

The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus

Clinical trial2026-06-25Results expected Q3 2027 · ClinicalTrials.gov

A Phase II Open-Label Pilot Trial Assessing the Safety of Anifrolumab in Adult Patients With Primary Antiphospholipid Syndrome (APS). The AnifAPS Trial

Clinical trial2026-06-02Results expected Q2 2028 · ClinicalTrials.gov

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus

Clinical trial2026-05-20Results posted · ClinicalTrials.gov

A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Clinical trial2026-02-24Results expected Q1 2027 · ClinicalTrials.gov

A Prospective Open-label Trial Examining the Efficacy and Safety of Anifrolumab for Hidradenitis Suppurativa (HS)

Clinical trial2026-01-22Primary completion · ClinicalTrials.gov

Type I interferon blockade with anifrolumab in patients with systemic lupus erythematosus modulates key immunopathological pathways in a gene expression and proteomic analysis of two phase 3 trials.

Research2024-07-15Annals of the rheumatic diseases

Approval: Saphnelo (EMA)

Regulatory2022-02-14EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Anifrolumab
Aliases & brands
Saphnelo
RxNorm CUI
2565265
ChEMBL ID
CHEMBL2364653
ATC codes
L04AG11
UNII
38RL9AE51Q
Primary mechanism
Interferon-alpha/beta receptor alpha chain antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interferon alpha/beta receptor 1
IFNAR1 · P17181
ANTAGONISTInterferon-alpha/beta receptor alpha chain antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-02-14
Latest approval
2022-02-14
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-02-14Approval
Approval: Saphnelo (EMA)
Indication: Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite… Show full indication

Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

24 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
24
registered trials across all phases
LATEST COMPLETION 2025
9
Active studies
6
Recruiting
10
Late-stage (III+)
12
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 24
Early Phase 11Phase 14Phase 29Phase 39Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab

RecruitingPH IVAstraZenecan=162027

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

Not yet recruitingPH IIIKey trialAstraZenecan=1,0722032

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy

RecruitingPH IIIAstraZenecan=1002030

Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

RecruitingPH IIIAstraZenecan=2452029

A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

Active, not recruitingPH IIIAstraZenecan=3592028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus

CompletedPH IIIAstraZenecan=2772025

A Randomized, Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Subcutaneously and Intravenously Delivered Anifrolumab in Healthy Chinese Participants

CompletedPH IAstraZenecan=242025

A Multicenter, Randomized, Open-label, Parallel Phase 1 Comparability Study of Anifrolumab Administered Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers

CompletedPH IAstraZenecan=1802023

A Phase I, Open-label, Single-Arm, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Anifrolumab in Chinese Participants With Systemic Lupus Erythematosus (SLE)

CompletedPH IAstraZenecan=152022

A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.

CompletedPH IIIAstraZenecan=5592021

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis

CompletedPH IIAstraZenecan=1472021

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes4
Antibodies, Monoclonal, Humanized1Interferon Type I1Lupus Erythematosus, Systemic1Proteomics1
Journals, researchers & institutions
Top journals
  • Annals of the rheumatic diseases1
Leading researchers
  • Al-Mossawi H1
  • Baker T1
  • Brohawn PZ1
  • Chamberlain C1
  • Csomor E1
  • Ferrari N1
  • Furie RA1
  • Gavin PG1
Leading institutions
free-text, unnormalised
  • Centre for Inflammatory Diseases1
  • Clinical & Quantitative Pharmacology1
  • Clinical Development1
  • Donald and Barbara Zucker School of Medicine at Hofstra/Northwell1
  • Leeds Institute of Rheumatic and Musculoskeletal Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.