Ianalumab

Phase 3Monoclonal antibody

Novartis

Ianalumab is one of 125 biologic programs targeting Systemic Lupus Erythematosus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

124

Competitors

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusRecruiting

Lupus NephritisActive, not recruiting

Primary Immune Thrombocytopenia (ITP)Active, not recruiting

Sjogren's SyndromeActive, not recruiting

Primary Immune ThrombocytopeniaActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

Systemic Lupus ErythematosusPhase 3

Recruiting

Lupus NephritisPhase 3

Active, not recruiting

Primary Immune Thrombocytopenia (ITP)Phase 2

Active, not recruiting

Sjogren's SyndromePhase 3

Active, not recruiting

Primary Immune ThrombocytopeniaPhase 3

Active, not recruiting

Immune ThrombocytopeniaPhase 3

Active, not recruiting

Competition

Competitive Landscape

134 competitors in Systemic Lupus Erythematosus

#DrugCompanyPhaseTrials

Rituxan

Roche

Phase 3

9 2

Medrol

Pfizer

Phase 3

5 3

Rinvoq

AbbVie

Phase 3

3 4

Cytoxan

BBaxter Healthcare Corporation

Phase 3

12 5

Gazyva

Roche

Phase 3

2 6

Sotyktu

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

3 7

Rapamune

PPrism Pharmaceuticals

Phase 3

1 8

Glucocorticoid

AbbVie

Phase 3

1 9

Blincyto

Amgen

Phase 2

2 10

Telitacicept

VVor Biopharma

Phase 3

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

Timeline

Expected Milestones

Q2 2028

Phase 3Active, not recruiting

Primary Immune Thrombocytopenia

NCT05653219

Q3 2028

Phase 3Active, not recruiting

Immune Thrombocytopenia

NCT05653349

Q4 2028

Phase 3Active, not recruiting

Warm Autoimmune Hemolytic Anemia (waiha)

NCT05648968

Q1 2029

Phase 2Active, not recruiting

Primary Immune Thrombocytopenia (ITP)

NCT05885555

Phase 3Active, not recruiting

Systemic Lupus Erythematosus

NCT05639114

Clinical

Trials by Indication[1]

Primary Immune Thrombocytopenia (ITP)3 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 Study to Evaluate the Efficacy and Safety of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least a Corticosteroid and a Thrombopoietin Receptor Agonist (TPO-RA)

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT05885555·41 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

Systemic Lupus Erythematosus3 trials

A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 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

A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 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

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

A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN).

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05126277·452 enrolled

Primary Immune Thrombocytopenia2 trials

A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05653219·152 enrolled

A Phase 2 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

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

7 more indications

Immune Thrombocytopenia1 trial

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

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

Warm Autoimmune Hemolytic Anemia (wAIHA)1 trial

A Phase 3, Randomized, Double-blind, Study to Assess Efficacy and Safety of Ianalumab (VAY736) Versus Placebo in Warm Autoimmune Hemolytic Anemia (wAIHA) Patients Who Failed at Least One Line of Treatment

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05648968·90 enrolled

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]

Primary Immune Thrombocytopenia (ITP)3 trials

Systemic Lupus Erythematosus3 trials

Lupus Nephritis2 trials

Primary Immune Thrombocytopenia2 trials

ESS1 trial

Immune Thrombocytopenia1 trial

Rheumatoid Arthritis1 trial

Autoimmune Disease1 trial

Aged1 trial

Warm Autoimmune Hemolytic Anemia (wAIHA)1 trial

Diffuse Cutaneous Systemic Sclerosis1 trial

Sjogren's Syndrome1 trial

References

Drug Info

Quick Facts

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