Ianalumab History and Updates

55 events · 2018 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
54
Trial Milestones
1
Pivotal Publications
Ianalumab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications201920202021202220232024202520262027202820292030203120322033Trial: NCT07421167 2026-11-11 → 2029-01-10 (primary completion)Trial: NCT07039422 2026-06-26 → 2030-08-30 (primary completion)Trial: NCT06711887 2025-05-19 → 2030-07-16 (primary completion)Trial: NCT06411639 2024-11-25 → 2025-12-17 (primary completion)Trial: NCT06470048 2024-10-09 → 2027-07-30 (primary completion)Trial: NCT06133972 2024-05-21 → 2030-04-08 (primary completion)Trial: NCT05985915 2023-10-27 → 2033-04-22 (primary completion)Trial: NCT05885555 2023-08-16 → 2025-02-05 (primary completion)Trial: NCT05624749 2023-04-21 → 2027-04-12 (primary completion)Trial: NCT05639114 2023-03-02 → 2027-03-24 (primary completion)Trial: NCT05653349 2023-02-03 → 2026-10-29 (primary completion)Trial: NCT05653219 2023-02-02 → 2025-06-19 (primary completion)Trial: NCT05648968 2022-12-30 → 2026-02-20 (primary completion)Trial: NCT05124925 2022-07-27 → 2024-06-26 (primary completion)Trial: NCT05126277 2022-07-14 → 2027-06-22 (primary completion)Trial: NCT03574545 2018-12-19 → 2024-07-18 (primary completion)Pivotal publication — 2026-01-01 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 Steroidstoday (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download 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
2025

Upcoming & expected milestones

Trial started· 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 started· 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
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05653349
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Trial started· 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
Primary completion· 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 completion· 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 completion· 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 completion· 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 completion· 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 completion· 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 completion· 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 completion· 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 completion· 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 completion· 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

Past events

2026
Trial started· 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 completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05648968
A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
2025
Primary completion· 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 started· 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 completion· 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 started· ClinicalTrials.gov
Phase 2 trial started: NCT06470048
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
Primary completion· 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 started· 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).
2023
Trial started· 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 started· 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 started· 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 started· 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 started· ClinicalTrials.gov
Phase 3 trial started: NCT05653349
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Trial started· 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 started· 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 started· 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 started· 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
2018

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.