Ianalumab

Summary

Ianalumab (CHEMBL4594357) is a phase-3 clinical-stage antibody targeting TNFRSF13C; indicated across 20 conditions including sjogren syndrome and lupus nephritis.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (TNFRSF13C)
• Indications: 20 conditions
• Clinical trials: 31

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4594357
Name	Ianalumab
Type	Antibody
Max phase	3

Also known as: Ianalumab, NVP-VAY736, VAY-736, Vay736, VAY736, IANALUMAB

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
TNFRSF13C	BAFF receptor	Antagonist	10.72	0%	Q96RJ3

Bioactivity

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

Target pathways

Aggregated over 1 target gene(s): TNFRSF13C.

Top Reactome pathways

2 total, by targets touching each:

Pathway	Targets	Genes
TNFR2 non-canonical NF-kB pathway	1	TNFRSF13C
TNF receptor superfamily (TNFSF) members mediating non-canonical NF-kB pathway	1	TNFRSF13C

Dominant GO biological processes

GO term	Targets
adaptive immune response	1
positive regulation of B cell proliferation	1
T cell costimulation	1
B cell costimulation	1
tumor necrosis factor-mediated signaling pathway	1
positive regulation of T cell proliferation	1
immune system process	1

Indications & clinical

Indications

20 indications (0 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
Sjogren syndrome	3	MONDO:0010030	EFO:0000699
lupus nephritis	3	MONDO:0005556	EFO:0005761
autoimmune thrombocytopenic purpura	3	MONDO:0008558	EFO:0007160
autoimmune hemolytic anemia	3	MONDO:0020108	EFO:1001264
thrombocytopenia	3	MONDO:0002049	HP:0001873
idiopathic pulmonary fibrosis	2	MONDO:0800504	EFO:0000768
pemphigus vulgaris	2	MONDO:0008219	EFO:0004719
autoimmune hepatitis	2	MONDO:0016264	EFO:0005676
multiple sclerosis	2	MONDO:0005301	MONDO:0005301
diffuse scleroderma	2	MONDO:0005019	EFO:0000404
hidradenitis suppurativa	2	MONDO:0006559	EFO:1000710
rheumatoid arthritis	1	MONDO:0008383	EFO:0000685
B-cell chronic lymphocytic leukemia	1	MONDO:0004948	EFO:0000095
diffuse large B-cell lymphoma	1	MONDO:0018905	EFO:0000403
marginal zone lymphoma	1	MONDO:0017604	EFO:1000630
mantle cell lymphoma	1	MONDO:0018876	EFO:1001469
follicular lymphoma	1	MONDO:0018906	MONDO:0018906
neoplasm	1	MONDO:0005070	EFO:0000616
autoimmune disease	1	MONDO:0007179	EFO:0005809

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 31.

Phase distribution

Phase	Trials
PHASE2	13
PHASE3	10
PHASE1	6
PHASE2/PHASE3	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05349214	PHASE3	ACTIVE_NOT_RECRUITING	Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren’s Syndrome
NCT05350072	PHASE3	ACTIVE_NOT_RECRUITING	Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren’s Syndrome
NCT05624749	PHASE3	ACTIVE_NOT_RECRUITING	Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
NCT05639114	PHASE3	ACTIVE_NOT_RECRUITING	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)
NCT05648968	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
NCT05653219	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
NCT05653349	PHASE3	ACTIVE_NOT_RECRUITING	Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
NCT05985915	PHASE3	ACTIVE_NOT_RECRUITING	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 Sjogrens Syndrome.
NCT06133972	PHASE3	RECRUITING	Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
NCT06711887	PHASE3	RECRUITING	Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
NCT03217422	PHASE2/PHASE3	COMPLETED	ADCC Mediated B-Cell dEpletion and BAFF-R Blockade
NCT03827798	PHASE2	ACTIVE_NOT_RECRUITING	Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
NCT05885555	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
NCT06293365	PHASE2	ACTIVE_NOT_RECRUITING	Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
NCT06470048	PHASE2	RECRUITING	A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
NCT07039422	PHASE2	RECRUITING	Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
NCT07421167	PHASE2	RECRUITING	A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator’s Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
NCT01930175	PHASE2	TERMINATED	Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris
NCT02038049	PHASE2	TERMINATED	A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis
NCT02149420	PHASE2	COMPLETED	PD of VAY736 in Patients With Primary Sjögren’s Syndrome
NCT02962895	PHASE2	COMPLETED	Safety and Efficacy of VAY736 in Patients With Primary Sjogren’s Syndrome (pSS)
NCT03287414	PHASE2	TERMINATED	Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
NCT03656562	PHASE2	COMPLETED	Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
NCT05124925	PHASE2	COMPLETED	Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.
NCT02137889	PHASE1	TERMINATED	Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VAY736 in Relapsed or Refractory CLL Patients
NCT02675803	PHASE1	COMPLETED	Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis Patients
NCT03400176	PHASE1	TERMINATED	VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib
NCT03574545	PHASE1	COMPLETED	Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis
NCT04903197	PHASE1	TERMINATED	Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
NCT06411639	PHASE1	WITHDRAWN	Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases
NCT07244289	Not specified	AVAILABLE	Managed Access Programs for VAY736, Ianalumab

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).