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Saphnelo

(Anifrolumab)

ApprovedMonoclonal antibody

Anifrolumab is used to treat systemic lupus erythematosus (SLE), an autoimmune disease where the body's immune system attacks its own tissues, causing inflammation and damage to joints, skin, kidneys, and other organs.[2] Saphnelo is currently approved and in use across 6 indications[4].[1]

Saphnelo is one of 120 monoclonal antibody programs targeting Lupus. It is currently in Approved.

6

Indications

32

Total Trials

15

Active Trials

119

Competitors

7

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

LupusNot yet recruiting

Systemic Lupus ErythematosusRecruiting

Lupus Erythematosus, SystemicNot yet recruiting

Lupus NephritisActive, not recruiting

VitiligoRecruiting

LupusPhase 3

Not yet recruiting

Systemic Lupus ErythematosusApproved

Recruiting

Lupus Erythematosus, SystemicPhase 3

Not yet recruiting

Lupus NephritisPhase 3

Active, not recruiting

VitiligoPhase 2

Recruiting

Competition

Competitive Landscape

134 competitors in Systemic Lupus Erythematosus

#DrugCompanyPhaseTrials

Saphnelo

Rituxan

Medrol

Rinvoq

Cytoxan

BBaxter Healthcare Corporation

Gazyva

Sotyktu

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Rapamune

PPrism Pharmaceuticals

Ianalumab

Fludara

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Not yet recruiting

Fatigue

NCT06784076

Q3 2027

Phase 2Recruiting

Systemic Lupus Erythematosus

NCT05440422

ApprovedRecruiting

Systemic Lupus Erythematosus

NCT06594068

Q2 2028

Active, not recruiting

Lupus Erythematosus, Systemic

NCT06673043

Q3 2028

Phase 3Not yet recruiting

Lupus Erythematosus, Systemic

NCT07751848

Lupus Erythematosus, Systemic

NCT07330245

Clinical

Trials by Indication[1]

Systemic Lupus Erythematosus14 trials

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT04931563·277 enrolled

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02446899·373 enrolled

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01438489·626 enrolled

Show 11 more trials

Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05001698·15 enrolled

Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02794285·559 enrolled

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

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT02962960·36 enrolled

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02446912·460 enrolled

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

Recruiting·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 2·NCT05440422·45 enrolled

A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab

Recruiting· AstraZeneca logo

AstraZeneca··NCT07000110·3,506 enrolled

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

Recruiting· AstraZeneca logo

AstraZeneca·Approved·NCT06594068·16 enrolled

Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program

Recruiting· AstraZeneca logo

AstraZeneca··NCT06795893·240 enrolled

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

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05835310·100 enrolled

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)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07430306·245 enrolled

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab

Recruiting· AstraZeneca logo

AstraZeneca··NCT06659029·442 enrolled

Lupus Erythematosus, Systemic3 trials

Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study

Active, not recruiting· AstraZeneca logo

AstraZeneca··NCT06673043·105 enrolled

DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosus in Italy

Recruiting· AstraZeneca logo

AstraZeneca··NCT07330245·218 enrolled

Multicentre, Open-Label, Single-Arm, 52-Week, Ph3b Study to Evaluate the Efficacy and Safety Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Moderate-Severe Systemic Lupus Erythematosus (SLE)

Not yet recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07751848·417 enrolled

ESS2 trials

Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05339100·180 enrolled

Anifrolumab Early Access Program

No longer available· AstraZeneca logo

AstraZeneca··NCT04750057

Lupus Nephritis2 trials

Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT02547922·147 enrolled

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 recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05138133·363 enrolled

Female1 trial

Saphnelo Use in Females of Child-bearing Potential

Not yet recruiting· AstraZeneca logo

AstraZeneca··NCT07431775·26,000,000 enrolled

10 more indications

Vitiligo1 trial

Efficacy and Tolerance of the Association of ANIFROLUMAB (300mg) IV Every Four Weeks and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

Recruiting·UUniversity Hospital, Bordeaux·Phase 2·NCT05917561·48 enrolled

Fatigue1 trial

Establishing the Salience of Type 1 Interferon Pathway Blockade in the Central Mechanisms of SLE Related Fatigue

Not yet recruiting·NNHS Greater Glasgow and Clyde··NCT06784076·20 enrolled

Immunity1 trial

Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE

Unknown status·OOklahoma Medical Research Foundation·Phase 1·NCT04726553·20 enrolled

Single Dose1 trial

A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02601625·30 enrolled

Intravenous1 trial

Pharmacokinetic and Safety Study of Subcutaneous and Intravenous Anifrolumab Delivered in Healthy Adult Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06662123·24 enrolled

Primary Sjögren's Syndrome1 trial

Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome

Unknown status·UUniversity Medical Center Groningen·Phase 2·NCT05383677·30 enrolled

Treatment1 trial

An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01753193·218 enrolled

Hidradenitis Suppurativa1 trial

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

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT06374212·15 enrolled

Lupus1 trial

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 recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07691970·1,072 enrolled

Unspecified1 trial

A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)

Unknown status·JJosef Smolen, Univ. Prof. Dr.·Phase 2·NCT03435601·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 30, 2021

SAPHNELO

NDA BLA761123

Jul 30, 2021

SAPHNELO

BLA BLA761123

Dec 1, 2023

SAPHNELO

NDA BLA761123

Aug 7, 2024

SAPHNELO

NDA BLA761123

Apr 24, 2026

SAPHNELO

BLA BLA761451

Apr 24, 2026

SAPHNELO

NDA BLA761451

Aug 7, 2026

SAPHNELO

NDA BLA761123

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Anifrolumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Saphnelo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Anifrolumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Anifrolumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761123). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Anifrolumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Type I IFN Receptor Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Key Publications[6]

Anifrolumab in Systemic Lupus Erythematosus: TULIP-2 Extended Analysis

Lancet RheumatolFeb 8, 2023DOI: 10.1016/S2665-9913(23)00025-X

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