Ianalumab History and Updates

65 events · 2018 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: October 16, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-10-16Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Ianalumab since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (3)

2026

Primary completionIanalumab Phase 3 wAIHA Trial Reaches Primary Completion· Feb 20, 2026
Pivotal publicationIanalumab Plus Eltrombopag Trial Results in Immune Thrombocytopenia Published· Jan 1, 2026

2025

Primary completionIanalumab Phase 3 Primary Immune Thrombocytopenia Trial Completes· Jun 19, 2025

Upcoming & expected milestones

Primary completionOct 29, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05653349

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

Trial startedNov 11, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Trial startedFeb 8, 2027· ClinicalTrials.gov

Phase 2 trial started: NCT07660172

A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.

Primary completionMar 3, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Primary completionMar 24, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05639114

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

Primary completionMar 26, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05639114

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

Primary completionApr 12, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05624749

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

Primary completionJun 22, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05126277

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

Primary completionJul 6, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06470048

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

Primary completionJul 30, 2027· ClinicalTrials.gov

Phase 2 primary completion: NCT06470048

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

Primary completionSep 21, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05126277

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

Primary completionApr 1, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Primary completionMay 9, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Primary completionDec 26, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Primary completionJan 10, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Primary completionJan 18, 2029· ClinicalTrials.gov

Phase 2 primary completion: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Primary completionApr 8, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT06133972

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Primary completionJul 16, 2030· ClinicalTrials.gov

Phase 3 primary completion: NCT06711887

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephriti

Primary completionAug 30, 2030· ClinicalTrials.gov

Phase 2 primary completion: NCT07039422

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

Primary completionApr 22, 2033· ClinicalTrials.gov

Phase 3 primary completion: NCT05985915

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 I

Primary completionApr 22, 2033· ClinicalTrials.gov

Phase 2 primary completion: NCT07660172

A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.

Primary completionApr 3, 2034· ClinicalTrials.gov

Phase 3 primary completion: NCT06133972

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Primary completionAug 1, 2035· ClinicalTrials.gov

Phase 3 primary completion: NCT06711887

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephriti

Past events

2026

Trial startedJun 29, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Trial startedJun 26, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07039422

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

Trial registeredJun 22, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07660172

A Phase 2, Single-arm Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.

Trial startedApr 27, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT07039422

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

Primary completionFeb 20, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05648968

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

Trial registeredFeb 19, 2026· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07421167

A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients

Pivotal publicationJan 1, 2026· PubMed

Ianalumab plus Eltrombopag in Immune Thrombocytopenia. (N Engl J Med)

VAYHIT2 — A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

2025

Primary completionDec 17, 2025· ClinicalTrials.gov

Phase 1 primary completion: NCT06411639

Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Trial registeredNov 24, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07244289

Managed Access Programs for VAY736, Ianalumab

Trial registeredJun 26, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT07039422

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

Primary completionJun 19, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05653219

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

Trial startedMay 19, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06711887

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephriti

Primary completionFeb 5, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05885555

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

2024

Trial registeredDec 2, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06711887

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephriti

Trial startedNov 25, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06411639

Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Trial startedOct 9, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06470048

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

Primary completionJul 18, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT03574545

Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Primary completionJun 26, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05124925

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

Trial registeredJun 24, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06470048

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

Trial startedMay 21, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06133972

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Trial registeredMay 13, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06411639

Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

2023

Trial registeredNov 18, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06133972

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

Trial startedOct 27, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05985915

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 I

Trial startedAug 16, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT05885555

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

Trial registeredAug 14, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05985915

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 I

Trial registeredJun 2, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05885555

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

Trial startedApr 21, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05624749

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

Trial startedMar 2, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05639114

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

Trial startedFeb 3, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05653349

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

Trial startedFeb 2, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05653219

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

2022

Trial startedDec 30, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05648968

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

Trial registeredDec 16, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05653349

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

Trial registeredDec 16, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05653219

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

Trial registeredDec 13, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05648968

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

Trial registeredDec 6, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05639114

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

Trial registeredNov 22, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05624749

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

Trial startedJul 27, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05124925

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

Trial startedJul 14, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05126277

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

2021

Trial registeredNov 19, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05126277

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

Trial registeredNov 18, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05124925

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

2018

Trial startedDec 19, 2018· ClinicalTrials.gov

Phase 1 trial started: NCT03574545

Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Trial registeredJul 2, 2018· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT03574545

Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.