Ianalumab

Phase 3Monoclonal antibody

Novartis

Ianalumab is one of 203 biologic programs targeting Systemic Lupus Erythematosus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

202

Competitors

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Autoimmune DiseaseActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

Systemic SclerosisActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

Warm Autoimmune Hemolytic AnemiaActive, not recruiting

Lupus NephritisActive, not recruiting

Primary Immune Thrombocytopenia (ITP)Not yet recruiting

Sjogren's SyndromeActive, not recruiting

Diffuse Cutaneous Systemic SclerosisRecruiting

Systemic Lupus ErythematosusPhase 3

Active, not recruiting

Autoimmune DiseasePhase 1

Active, not recruiting

Rheumatoid ArthritisPhase 1

Active, not recruiting

Systemic SclerosisPhase 2

Active, not recruiting

Immune ThrombocytopeniaPhase 2

Active, not recruiting

Warm Autoimmune Hemolytic AnemiaPhase 3

Active, not recruiting

Lupus NephritisPhase 3

Active, not recruiting

Primary Immune Thrombocytopenia (ITP)Phase 2

Not yet recruiting

Sjogren's SyndromePhase 3

Active, not recruiting

Diffuse Cutaneous Systemic SclerosisPhase 2

Recruiting

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Ianalumab

Novartis

Phase 3

1 2

Rituxan

Roche

Preclinical

61 3

Orencia

Bristol-Myers Squibb

Preclinical

47 4

Simponi

Johnson & Johnson

Preclinical

19 5

Enbrel

IImmunex

Preclinical

64 6

Kevzara

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

14 7

Celexa

AbbVie

Preclinical

1 8

Zelhou

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

7 9

Kineret

SSwedish Orphan Biovitrum

Preclinical

6 10

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

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

Timeline

Expected Milestones

Q2 2028

Phase 3Active, not recruiting

Immune Thrombocytopenia

NCT05653219

Q3 2028

Phase 3Active, not recruiting

Immune Thrombocytopenia

NCT05653349

Q4 2028

Phase 3Active, not recruiting

Warm Autoimmune Hemolytic Anemia

NCT05648968

Q1 2029

Phase 2Active, not recruiting

Immune Thrombocytopenia

NCT05885555

Phase 3Active, not recruiting

Systemic Lupus Erythematosus

NCT05639114

Clinical

Trials by Indication[1]

Immune Thrombocytopenia4 trials

Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab

Recruiting· Novartis logo

Novartis·Phase 2·NCT07039422·60 enrolled

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05653349·226 enrolled

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05653219·152 enrolled

Show 1 more trial

A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT05885555·41 enrolled

Systemic Lupus Erythematosus3 trials

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05639114·436 enrolled

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05624749·288 enrolled

A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

Recruiting· Novartis logo

Novartis·Phase 3·NCT06133972·550 enrolled

Lupus Nephritis2 trials

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Recruiting· Novartis logo

Novartis·Phase 3·NCT05126277·462 enrolled

An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)

Recruiting· Novartis logo

Novartis·Phase 3·NCT06711887·348 enrolled

Primary Immune Thrombocytopenia (ITP)2 trials

A Phase 2 Open-label Study to Evaluate the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least One Treatment (VAY2EXPLORE)

Recruiting· Novartis logo

Novartis·Phase 2·NCT07421167·164 enrolled

A Phase 2, Open-label, Single-arm Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary Immune Thrombocytopenia Who Had an Insufficient Response to or Relapsed After First-line Corticosteroid Treatment (VAYHIT-P).

Not yet recruiting· Novartis logo

Novartis·Phase 2·NCT07660172·36 enrolled

ESS1 trial

Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.

Completed· Novartis logo

Novartis·Phase 2·NCT05124925·21 enrolled

6 more indications

Warm Autoimmune Hemolytic Anemia1 trial

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05648968·90 enrolled

Rheumatoid Arthritis1 trial

Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Completed· Novartis logo

Novartis·Phase 1·NCT03574545·48 enrolled

Autoimmune Disease1 trial

Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Withdrawn· Novartis logo

Novartis·Phase 1·NCT06411639

Aged1 trial

Managed Access Programs for VAY736, Ianalumab

Available· Novartis logo

Novartis··NCT07244289

Diffuse Cutaneous Systemic Sclerosis1 trial

A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

Recruiting· Novartis logo

Novartis·Phase 2·NCT06470048·200 enrolled

Sjogren's Syndrome1 trial

A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjögren's Syndrome

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05985915·612 enrolled

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Ianalumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ianalumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ianalumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Novartis

Ianalumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Q3 2028

Q4 2028

Q1 2029

Trials by Indication[1]

Immune Thrombocytopenia4 trials

Systemic Lupus Erythematosus3 trials

Lupus Nephritis2 trials

Primary Immune Thrombocytopenia (ITP)2 trials

ESS1 trial

Warm Autoimmune Hemolytic Anemia1 trial

Rheumatoid Arthritis1 trial

Autoimmune Disease1 trial

Aged1 trial

Diffuse Cutaneous Systemic Sclerosis1 trial

Sjogren's Syndrome1 trial

References

Drug Info

Quick Facts

Related News