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Anifrolumab · Saphnelo, Medi-546

Monoclonal antibody · Antagonist of IFNAR1 · developed by Astrazeneca

Approved FDA, Jul 2021

AZN Developer

2 Registered trials

What is Anifrolumab?

Anifrolumab-fnia is a human IgG1κ monoclonal antibody that binds to IFNAR1 and blocks type I interferon signaling. It inhibits interferon-responsive gene expression and downstream inflammatory processes, reducing plasma cell differentiation and normalizing T-cell subsets.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Saphnelo, Medi-546, (MEDI-546)
Drug type: Monoclonal antibody
Targets: IFNAR1
Mechanism: Antagonist of IFNAR1
Pathways: type I interferon signaling, plasma cell differentiation, T-cell subset normalization
Therapy area: Immunology
Developer: Astrazeneca Ab (AZN)
Also in trials of: IQV
FDA status: Approved as Saphnelo (July 30, 2021), BLA761123 · FDA label
UNII: 38RL9AE51Q

✅ FDA-approved uses

Moderate to severe systemic lupus erythematosus

From the indications section of the FDA label (version of Apr 24, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05835310	Phase 3	Systemic Lupus Erythematosus	Recruiting	AZN
NCT04877691	Phase 3	Systemic Lupus Erythematosus	Active not recruiting	IQV

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Systemic Lupus Erythematosus

Other drugs acting on IFNAR1

Interferon Alfa-2b FDA approved Interferon Beta-1A FDA approved

More from Astrazeneca

Acalabrutinib FDA approved Benralizumab FDA approved Camizestrant FDA approved Durvalumab FDA approved Olaparib FDA approved Tremelimumab FDA approved Actinium Ac 225 FPI-2068 Phase 1 Adavosertib Phase 2 AZD0240 Phase 1 AZD4144 Phase 1 AZD4916 Phase 1 AZD5492 Phase 1/2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the AZN page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z