Ianalumab
An investigational treatment for Sjögren's Syndrome.
Drug facts
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).
- Novartis is also testing ianalumab in immune thrombocytopenia (ITP), where the Phase 3 VAYHIT2 trial of 152 adults, published in the New England Journal of Medicine, found that 4 monthly doses added to eltrombopag lengthened the time before treatment failed[1]. It is not approved for ITP.
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, China and Japan.
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, published in the New England Journal of Medicine on October 22, 2026, enrolled 275 and 504 adults with active Sjögren's disease.
In both, 300mg of ianalumab injected under the skin once a month lowered the ESSDAI disease activity score at week 48 more than placebo, by 1.3 points in NEPTUNUS-1 and 1.0 point in NEPTUNUS-2, while the every-3-months dose in NEPTUNUS-2 did not reach significance. Neither trial showed a significant difference in the share of people with a 5-point ESSDAI response or in symptom scores (SSSD and ESSPRI), and serious adverse events were similar to placebo, with more injection-site and injection-related reactions on ianalumab[5].
Novartis completed regulatory submissions in the US, EU, China and Japan in the first quarter of 2026, and the FDA granted priority review; no decision date has been made public[6]. 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.
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. In the Phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials, serious side effects happened about as often on ianalumab as on placebo, while non-serious reactions at the injection site and reactions to the injection were more common on ianalumab[5].
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, 300mg given once a month met the main goal, while 300mg given every 3 months did not. No dose is final because the drug is not yet approved.
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.
Availability and cost
Only available as the brand-name product.
Ianalumab treatment timeline for Sjögren's Syndrome
Tap how long you have been on Ianalumab to drop your pin on the road. Your answers stay on this device.
Stage 1 of 5 · Start to 2 mo
Starting ianalumab
You are starting ianalumab, an investigational therapy targeting the BAFF receptor on B cells. Ianalumab has Breakthrough Therapy designation from the FDA (January 2026), meaning early clinical evidence suggested it may offer substantial improvement over existing options. The FDA has also granted it priority review. Unlike pilocarpine and cevimeline, which only manage symptoms, ianalumab is designed to modify the disease itself by depleting the overactive B cells that attack your moisture-producing glands. Ianalumab aims to calm the immune activity behind Sjögren's rather than cure it. Researchers call this a disease-modifying approach, meaning it targets the underlying process rather than just the symptoms. If you are receiving ianalumab, you are likely enrolled in a clinical trial. Pilocarpine and cevimeline work in a different way from ianalumab. Whether they can be used during a trial depends on that trial's rules, which your study team can explain. The drug is given as a subcutaneous injection, typically monthly. Baseline assessments include disease activity scoring (ESSDAI: a 0-to-123 scale measuring disease activity across 12 organ domains, where higher scores mean more active disease), salivary flow rate, Schirmer test for tear production, immunoglobulin levels, B-cell counts, and autoantibody levels.
Coming up
Over the first 1-2 months, the drug begins depleting your pathogenic B cells. The clinical effects may not be immediately obvious because it takes time for B-cell depletion to translate into reduced glandular inflammation and improved function. In the 2 Phase 3 trials, symptom scores that include dryness, fatigue and pain did not differ significantly between ianalumab and placebo at week 48. Researchers are still studying whether gland function improves. Your study team will be monitoring your B-cell counts and immunoglobulin levels closely. Infection monitoring is important because depleting B cells reduces your ability to fight certain infections.
Get in touch with your rheumatologist if you notice
- Signs of serious infection: high fever, persistent cough, or looking very unwell (B-cell depletion impairs humoral immunity)
- Severe injection site reaction
- Rapidly dropping immunoglobulin levels (may need supplementation or treatment pause)
- New or worsening neurological symptoms (Sjögren's can involve the nervous system, and distinguishing treatment effect from disease is important)
- Signs of a serious allergic reaction after an injection, such as trouble breathing or swelling of the face or throat
- How long before I might notice improvement in my dryness symptoms?
- What should I expect from the B-cell depletion: will I be more susceptible to infections?
- Can I continue my pilocarpine or cevimeline while on ianalumab?
- What measurements will you use to determine whether the treatment is working?
- If my immunoglobulin levels drop, what does that mean for me practically?
- What happens at the end of the trial: will I have access to the drug if it works?
Every stage of Ianalumab treatment at a glance
Starting ianalumab Start to 2 mo
You are starting ianalumab, an investigational therapy targeting the BAFF receptor on B cells. Ianalumab has Breakthrough Therapy designation from the FDA (January 2026), meaning early clinical evidence suggested it may offer substantial improvement over existing options. The FDA has also granted it priority review. Unlike pilocarpine and cevimeline, which only manage symptoms, ianalumab is designed to modify the disease itself by depleting the overactive B cells that attack your moisture-producing glands. Ianalumab aims to calm the immune activity behind Sjögren's rather than cure it. Researchers call this a disease-modifying approach, meaning it targets the underlying process rather than just the symptoms. If you are receiving ianalumab, you are likely enrolled in a clinical trial. Pilocarpine and cevimeline work in a different way from ianalumab. Whether they can be used during a trial depends on that trial's rules, which your study team can explain. The drug is given as a subcutaneous injection, typically monthly. Baseline assessments include disease activity scoring (ESSDAI: a 0-to-123 scale measuring disease activity across 12 organ domains, where higher scores mean more active disease), salivary flow rate, Schirmer test for tear production, immunoglobulin levels, B-cell counts, and autoantibody levels.
Over the first 1-2 months, the drug begins depleting your pathogenic B cells. The clinical effects may not be immediately obvious because it takes time for B-cell depletion to translate into reduced glandular inflammation and improved function. In the 2 Phase 3 trials, symptom scores that include dryness, fatigue and pain did not differ significantly between ianalumab and placebo at week 48. Researchers are still studying whether gland function improves. Your study team will be monitoring your B-cell counts and immunoglobulin levels closely. Infection monitoring is important because depleting B cells reduces your ability to fight certain infections.
Early response evaluation 2 mo to 6 mo
You have been on ianalumab for 2-6 months. Your study team checks B cell counts to see how the drug is acting, and the team is evaluating your response using multiple measures: disease activity (ESSDAI), glandular function (salivary flow, Schirmer test), autoantibody levels, patient-reported symptoms, and biomarkers of B-cell activity. In two Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2, monthly ianalumab lowered ESSDAI scores more than placebo at week 48. Placebo groups also improved, so the average difference was about 1 point. Neither trial found a significant difference from placebo in symptom scores or in the share of people whose ESSDAI score fell by 5 points or more. Your study team will judge your response with the trial's own measures.
If you are responding: your study team will continue treatment per protocol. Researchers are studying whether lowering B-cell activity can help gland function over time. This is fundamentally different from secretagogues: instead of forcing damaged glands to work harder, ianalumab targets the immune activity that drives the disease. If response is unclear: the study team will continue to the protocol-defined assessment timepoints. Some measures in the trial are checked only at set visits, such as week 48. If you are not responding or having side effects: your study team will discuss whether to continue per protocol or consider alternative options.
Response assessment 6 mo to 1 yr
By 6-12 months, the study team has substantial data on your response. This is typically when the primary endpoint of the clinical trial is assessed. Your ESSDAI score, glandular function tests, patient-reported outcomes, and biomarkers are all being formally evaluated. In NEPTUNUS-1 and NEPTUNUS-2, monthly 300mg ianalumab lowered the ESSDAI disease activity score by 1.3 and 1.0 points more than placebo at week 48. Symptom scores for dryness, fatigue and pain did not differ significantly from placebo.
If you are in the active treatment arm and responding: continued treatment per protocol, with the possibility of entering an open-label extension phase. If you were on placebo and the trial has unblinded: you may be offered active drug. Both Phase 3 trials met their main goal, and Novartis has filed with the FDA. The FDA granted priority review. Novartis has not announced a decision date, and no FDA decision had been reported by November 8, 2026. Your study team will discuss your options for continued access to the drug.
Continued treatment 1 yr to 2 yr
You have been on ianalumab for over a year. Ianalumab is being studied to find out whether lowering B cell activity can slow Sjögren's over the long term. Long-term results come from the NEPTUNUS extension study, which is still running. Your care now involves ongoing treatment (potentially through an open-label extension of the trial), monitoring for sustained response and long-term safety, and comprehensive Sjögren's management including dental care and dry eye treatment. Even with disease modification, some glandular damage may be irreversible, so symptom management alongside ianalumab may still be needed.
The path forward depends on the regulatory timeline. If ianalumab receives FDA approval (it is under priority review, which shortens the review clock), you may transition from clinical trial access to a commercial prescription. If the regulatory process takes longer, continued access through the trial or expanded access programs may be available. Regardless, long-term monitoring of immunoglobulin levels, infection risk, and disease activity continues.
Long-term treatment 2 yr on
You have been on ianalumab for more than 2 years. Long-term use of ianalumab is being studied in the NEPTUNUS extension study. Its long-term benefits and risks are not yet known.
Long-term management focuses on maintaining disease control, monitoring for cumulative immunosuppression effects, and comprehensive Sjögren's care. As more data accumulates from clinical use, the understanding of optimal treatment duration, potential treatment holidays, and combination approaches will evolve. Other investigational medicines, such as deucravacitinib, dazodalibep and telitacicept, are also being tested in Sjögren's disease.
This timeline shows typical patterns from the prescribing information, guidelines and published studies. Your own treatment may differ, and your rheumatologist is the source of truth for your plan. Last checked against the FDA label on .
Sources
- Novartis ianalumab Breakthrough Therapy Designation (January 2026)
- Ianalumab Phase 2 Sjögren's data: Bowman et al. (Lancet, 2022)
- Mariette et al., Ianalumab for the Treatment of Patients with Sjögren's Disease (NEJM, 2026)
- Novartis Q1 2026 results, April 28, 2026
- ACR/EULAR Sjögren's Classification Criteria
- NEPTUNUS-1 and NEPTUNUS-2 Phase 3 results, ACR 2025 abstract LB24
- Sjögren's Foundation
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.
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, China 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. In the Phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials, serious side effects happened about as often on ianalumab as on placebo, while non-serious reactions at the injection site and reactions to the injection were more common on ianalumab[5].
▸How is Ianalumab taken?
Given as an injection under the skin. In the Phase 3 NEPTUNUS trials, 300mg given once a month met the main goal, while 300mg given every 3 months did not. No dose is final because the drug is not yet approved.
▸Is Ianalumab FDA approved?
Not yet. Ianalumab is under FDA review for Sjögren's Syndrome; Novartis has filed an application and a decision is pending. The FDA calendar page tracks the outcome.
▸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. [6]
▸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. [2]
▸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. In the Phase 3 NEPTUNUS-1 and NEPTUNUS-2 trials, serious side effects happened about as often as on placebo, while non-serious injection-site and injection-related reactions were more common on ianalumab. [3][5]
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.
- New England Journal of Medicine · 2026-04-16. Ianalumab plus Eltrombopag in Immune Thrombocytopenia. https://pubmed.ncbi.nlm.nih.gov/41363800/
- Novartis · 2026-01-16. Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren's disease. 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
- New England Journal of Medicine · 2026-10-22. Ianalumab for the Treatment of Patients with Sjögren's Disease (NEPTUNUS-1 and NEPTUNUS-2). https://pubmed.ncbi.nlm.nih.gov/42906087/
- Novartis · 2026-04-28. Novartis delivered strong growth in priority brands and launches in Q1; FY 2026 guidance reaffirmed. https://www.novartis.com/news/media-releases/novartis-delivered-strong-growth-priority-brands-and-launches-q1-fy-2026-guidance-reaffirmed