Anifrolumab

Summary

Anifrolumab (CHEMBL2364653) is an approved antibody (ATC L04AG11) targeting IFNAR1; indicated across 8 conditions including systemic lupus erythematosus and lupus nephritis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L04AG11
• Targets: 1 (IFNAR1)
• Indications: 8 conditions
• Clinical trials: 35

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2364653
Name	Anifrolumab
Type	Antibody
Max phase	4
ATC	L04AG11

Also known as: Anifrolumab, Anifrolumab fnia, Anifrolumab-fnia, MEDI-546, Saphnelo, ANIFROLUMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
IFNAR1	interferon α/β receptor 1	Binding	10	0.1%	P17181

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): IFNAR1.

Top Reactome pathways

16 total, by targets touching each:

Pathway	Targets	Genes
Cytokine Signaling in Immune system	1	IFNAR1
Disease	1	IFNAR1
Immune System	1	IFNAR1
Infectious disease	1	IFNAR1
Interferon alpha/beta signaling	1	IFNAR1
Regulation of IFNA/IFNB signaling	1	IFNAR1
Interferon Signaling	1	IFNAR1
Potential therapeutics for SARS	1	IFNAR1
SARS-CoV Infections	1	IFNAR1
SARS-CoV-2 Infection	1	IFNAR1
SARS-CoV-2 activates/modulates innate and adaptive immune responses	1	IFNAR1
SARS-CoV-2-host interactions	1	IFNAR1
Respiratory Syncytial Virus Infection Pathway	1	IFNAR1
Viral Infection Pathways	1	IFNAR1
Evasion by RSV of host interferon responses	1	IFNAR1
RSV-host interactions	1	IFNAR1

Dominant GO biological processes

GO term	Targets
cell surface receptor signaling pathway via JAK-STAT	1
response to virus	1
response to lipopolysaccharide	1
cellular response to interferon-alpha	1
cellular response to interferon-beta	1
type I interferon-mediated signaling pathway	1
cellular response to virus	1
positive regulation of cellular respiration	1
regulation of transcription by RNA polymerase II	1
positive regulation of metabolic process	1
cytokine-mediated signaling pathway	1
regulation of receptor signaling pathway via JAK-STAT	1
positive regulation of protein localization to nucleus	1

Indications & clinical

Indications

8 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
systemic lupus erythematosus	4	MONDO:0007915	MONDO:0007915
lupus nephritis	3	MONDO:0005556	EFO:0005761
cutaneous lupus erythematosus	3	MONDO:0005282	EFO:0003834
rheumatoid arthritis	2	MONDO:0008383	EFO:0000685
Sjogren syndrome	2	MONDO:0010030	EFO:0000699
vitiligo	2	MONDO:0008661	EFO:0004208
hidradenitis suppurativa	2	MONDO:0006559	EFO:1000710
scleroderma	1	MONDO:0019340	EFO:1001993

Clinical trials

Total trials: 35.

Phase distribution

Phase	Trials
PHASE3	11
PHASE2	10
Not specified	8
PHASE1	4
PHASE4	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06594068	PHASE4	RECRUITING	Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
NCT04877691	PHASE3	ACTIVE_NOT_RECRUITING	Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
NCT05138133	PHASE3	ACTIVE_NOT_RECRUITING	Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
NCT05835310	PHASE3	RECRUITING	An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
NCT05925803	PHASE3	ACTIVE_NOT_RECRUITING	Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
NCT06015737	PHASE3	ACTIVE_NOT_RECRUITING	A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
NCT06455449	PHASE3	RECRUITING	A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
NCT07430306	PHASE3	RECRUITING	A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
NCT02446899	PHASE3	COMPLETED	Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446912	PHASE3	COMPLETED	Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02794285	PHASE3	COMPLETED	Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
NCT04931563	PHASE3	COMPLETED	Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
NCT05440422	PHASE2	RECRUITING	The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD
NCT06374212	PHASE2	ACTIVE_NOT_RECRUITING	Anifrolumab for Hidradenitis Suppurativa
NCT07584083	PHASE2	NOT_YET_RECRUITING	Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)
NCT01438489	PHASE2	COMPLETED	A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
NCT01559090	PHASE2	COMPLETED	Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
NCT01753193	PHASE2	COMPLETED	An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
NCT02547922	PHASE2	COMPLETED	Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
NCT02962960	PHASE2	COMPLETED	A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
NCT03435601	PHASE2	UNKNOWN	A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)
NCT05383677	PHASE2	UNKNOWN	Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren’s Syndrome
NCT00930683	PHASE1	COMPLETED	A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma
NCT05001698	PHASE1	COMPLETED	Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)
NCT05339100	PHASE1	COMPLETED	Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab
NCT06662123	PHASE1	COMPLETED	Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants
NCT04726553	EARLY_PHASE1	UNKNOWN	Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE
NCT06659029	Not specified	RECRUITING	Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
NCT06673043	Not specified	RECRUITING	Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus
NCT06784076	Not specified	NOT_YET_RECRUITING	Establishing the Salience of Type 1 Interferon Pathway Blockade in the Central Mechanisms of SLE Related Fatigue
NCT06795893	Not specified	RECRUITING	The Anifrolumab PRIM Program
NCT07000110	Not specified	RECRUITING	Anifrolumab Malignancy and Serious Infections Study
NCT07330245	Not specified	RECRUITING	Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
NCT07431775	Not specified	NOT_YET_RECRUITING	Saphnelo Use in Females of Child-bearing Potential
NCT04750057	Not specified	NO_LONGER_AVAILABLE	Anifrolumab Early Access Program

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).