Ianalumab
An investigational treatment for Sjögren's Syndrome.
The same compound appears under different names depending on the context. Here is how to identify Ianalumab wherever you encounter it, plus the key facts at a glance.
- Generic name
- Ianalumab
- Development code
- VAY736
- Drug class
- Anti-BAFF receptor antibody
- Manufacturer
- Novartis
- How it's taken
- Given as an injection under the skin.
The most advanced investigational therapy for Sjögren's syndrome, with FDA Breakthrough Therapy designation granted in January 2026. Ianalumab targets B cells through the BAFF receptor, addressing the autoimmune B-cell activity that destroys moisture-producing glands.
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Where Ianalumab fits
Currently the most advanced disease-modifying therapy in development for Sjögren's syndrome, which has no FDA-approved disease-modifying treatment. If approved, ianalumab would be the first targeted therapy for the condition. Competes with several other pipeline agents including deucravacitinib (TYK2 inhibitor), telitacicept (dual BAFF/APRIL inhibitor), and dazodalibep (CD40L blocker).
How Ianalumab works
In Sjögren's syndrome, B cells (a type of immune cell) become overactive, infiltrating the salivary and tear glands and producing autoantibodies that attack the body's own moisture-producing tissues. A survival signal called BAFF (B-cell activating factor) keeps these rogue B cells alive and active. Ianalumab works by targeting the BAFF receptor directly on B cell surfaces.
Unlike rituximab (which targets CD20), ianalumab provides a dual mechanism: it depletes existing B cells through antibody-dependent cellular cytotoxicity and simultaneously blocks the BAFF survival signal that would allow new autoreactive B cells to emerge. This dual approach may provide more complete and sustained B-cell suppression.
In Phase 2 studies, ianalumab showed improvements in disease activity scores and salivary gland function. The FDA granted Breakthrough Therapy designation in January 2026, and Novartis has since submitted the Phase 3 data for review in the US, EU and Japan.
Mechanism: Fully human monoclonal antibody targeting the BAFF receptor (BAFF-R) on B cells, depleting mature B cells and blocking BAFF-mediated B-cell survival signaling that drives autoimmune gland destruction
Side effects and safety
In Phase 2 trials, the most commonly reported side effects were injection site reactions, upper respiratory infections, and decreased immunoglobulin levels. Because ianalumab depletes B cells, infection monitoring is important. Full safety data will come from the ongoing Phase 3 trials.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Ianalumab
Given as an injection under the skin. In the Phase 3 NEPTUNUS trials, 300 mg given once a month met the main goal, while 300 mg given every 3 months did not. No dose is final because the drug is not yet approved.
Availability and cost
Only available as the brand-name product.
Clinical trial results
Phase 2 studies demonstrated improvements in the ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index) and salivary gland function. The Phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials reported positive results, and Novartis has filed for approval in the US, EU, China and Japan. The FDA granted priority review; no decision date has been made public. The FDA also granted Breakthrough Therapy designation in January 2026, reflecting the agency's assessment that ianalumab may provide substantial improvement over existing treatment for Sjögren's syndrome.
Development history
Developed by Novartis as VAY736, ianalumab was designed to provide more targeted B-cell depletion than existing anti-CD20 therapies. Novartis advanced it through Sjögren's syndrome development after recognizing the central role of BAFF signaling in the disease. The Breakthrough Therapy designation in January 2026 positions it as potentially the first disease-modifying therapy approved for Sjögren's syndrome.
Explore Sjögren's Syndrome trials
Other Sjögren's Syndrome treatments
Where to access Ianalumab
Investigational: available only through clinical trial enrollment
Ianalumab has not been approved by the FDA and is not available by prescription. The only way for a patient to receive Ianalumab today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with the specialist who manages the patient's condition and knows their current treatment.
Primary active trial
ClinicalTrials.gov record NCT05349214
View full trial record on ClinicalTrials.gov →Trial status, site list, and eligibility are pulled from ClinicalTrials.gov. Confirm current recruitment status and nearest site directly with the study team before traveling.
Ianalumab in Trial Friend News and Guides
Common questions about Ianalumab
▸What is Ianalumab?
The most advanced investigational therapy for Sjögren's syndrome, with FDA Breakthrough Therapy designation granted in January 2026. Ianalumab targets B cells through the BAFF receptor, addressing the autoimmune B-cell activity that destroys moisture-producing glands.
▸How does Ianalumab work?
In Sjögren's syndrome, B cells (a type of immune cell) become overactive, infiltrating the salivary and tear glands and producing autoantibodies that attack the body's own moisture-producing tissues. A survival signal called BAFF (B-cell activating factor) keeps these rogue B cells alive and active. Ianalumab works by targeting the BAFF receptor directly on B cell surfaces.
Unlike rituximab (which targets CD20), ianalumab provides a dual mechanism: it depletes existing B cells through antibody-dependent cellular cytotoxicity and simultaneously blocks the BAFF survival signal that would allow new autoreactive B cells to emerge. This dual approach may provide more complete and sustained B-cell suppression.
In Phase 2 studies, ianalumab showed improvements in disease activity scores and salivary gland function. The FDA granted Breakthrough Therapy designation in January 2026, and Novartis has since submitted the Phase 3 data for review in the US, EU and Japan.
▸What are the side effects of Ianalumab?
In Phase 2 trials, the most commonly reported side effects were injection site reactions, upper respiratory infections, and decreased immunoglobulin levels. Because ianalumab depletes B cells, infection monitoring is important. Full safety data will come from the ongoing Phase 3 trials.
▸How is Ianalumab taken?
Given as an injection under the skin. In the Phase 3 NEPTUNUS trials, 300 mg given once a month met the main goal, while 300 mg given every 3 months did not. No dose is final because the drug is not yet approved.
▸Is Ianalumab FDA approved?
Ianalumab is currently in phase 3 clinical trials for Sjögren's Syndrome. It has not yet received FDA approval.
▸Is there an approved treatment for Sjogrens syndrome?
There is no FDA-approved disease-modifying treatment for Sjogren's syndrome as of 2026. Ianalumab is under FDA priority review and is the furthest along, with several other agents in Phase 3 trials. [4]
▸What is ianalumab for Sjogrens?
Ianalumab is an investigational antibody that targets the BAFF receptor on B cells, depleting the overactive B cells that attack moisture-producing glands in Sjogren's syndrome while also blocking the BAFF survival signal. It received FDA Breakthrough Therapy designation in January 2026. [1]
▸Is ianalumab FDA approved?
▸What are the side effects of ianalumab?
In Phase 2 trials, the most commonly reported side effects of ianalumab were injection site reactions, upper respiratory infections, and decreased immunoglobulin levels. Because ianalumab depletes B cells, infection monitoring is important, and full safety data will come from the Phase 3 trials. [2]
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Novartis · 2026-01-16. Ianalumab Receives Breakthrough Therapy Designation for Sjögren's Syndrome. https://www.novartis.com/news/media-releases/novartis-ianalumab-receives-fda-breakthrough-therapy-designation-sjogrens-disease
- The Lancet. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. https://pubmed.ncbi.nlm.nih.gov/34861168/
- ClinicalTrials.gov. Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome (NEPTUNUS-2). https://clinicaltrials.gov/study/NCT05349214
- Novartis AG / SEC · 2026-04-28. Novartis Financial Report Q1 2026 (Form 6-K). https://www.novartis.com/events/novartis-financial-results-q1-2026