Sjogren's Syndrome Pipeline Gains Strong Momentum with 22+ Therapies Across 20+ Companies, Led by Novartis, Amgen, and Bristol-Myers Squibb | DelveInsight

The Sjogren's syndrome therapeutic landscape is entering a transformative phase, driven by a surge in innovative drug development and increasing research focus on autoimmune modulation. Leading pharmaceutical and biotechnology companies, including Novartis, Amgen, Bristol-Myers Squibb, Horizon Therapeutics, and emerging players such as Rise Therapeutics and Resolve Therapeutics, are actively advancing next-generation therapies aimed at addressing the complex pathophysiology of Sjogren's syndrome.

According to DelveInsight's latest report, "Sjogren's Syndrome Pipeline Insight, 2026," the pipeline encompasses more than 20 companies and over 22 therapeutic candidates spanning early discovery to late-stage clinical development. The report delivers a comprehensive evaluation of pipeline drug profiles, clinical and nonclinical programs, and therapeutic segmentation based on product type, route of administration, stage of development, and molecule type. Additionally, it provides critical insights into inactive and discontinued programs, offering a holistic view of the evolving Sjogren's syndrome research ecosystem.

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Understanding Sjogren's Syndrome: A Complex Autoimmune Disorder with Systemic Impact
Sjogren's syndrome (SS) is a chronic autoimmune disease characterized by immune-mediated destruction of exocrine glands, particularly the salivary and lacrimal glands. This results in hallmark symptoms such as persistent dry mouth (xerostomia) and dry eyes (keratoconjunctivitis sicca), significantly impairing patients' quality of life.

The disease involves aberrant immune activation, where lymphocytic infiltration leads to chronic inflammation and progressive glandular dysfunction. Elevated levels of cytokines, chemokines, and autoantibodies further exacerbate tissue damage, contributing to systemic manifestations beyond the exocrine system.

Clinically, Sjogren's syndrome is broadly categorized into primary and secondary forms. Primary SS occurs independently, whereas secondary SS is associated with other autoimmune conditions such as systemic lupus erythematosus, rheumatoid arthritis, or scleroderma. Despite this classification, therapeutic approaches remain largely similar due to overlapping disease mechanisms.

A defining pathological feature of SS is focal lymphocytic sialadenitis (FLS), marked by dense infiltration of immune cells-primarily T lymphocytes-within glandular tissues. As disease severity progresses, these infiltrates can lead to irreversible glandular damage, resulting in reduced tear and saliva production. In advanced cases, systemic complications such as pulmonary, renal, and dermatological involvement may occur. Rarely, patients may develop non-Hodgkin lymphoma due to malignant transformation of B cells.
Current treatment strategies are largely symptomatic, focusing on moisture replacement and immunosuppression.

While therapies such as artificial tears and saliva substitutes provide relief, they do not address the underlying autoimmune pathology. Advanced interventions, including autologous serum eye drops and platelet-derived therapies, show promise but remain limited by cost and accessibility.

Sjogren's Syndrome Pipeline Landscape: Innovation Driving Therapeutic Advancements
The Sjogren's syndrome pipeline is witnessing a paradigm shift, fueled by advancements in immunology, molecular biology, and targeted therapy development. The growing understanding of disease mechanisms-particularly B-cell activation, cytokine signaling, and immune dysregulation-is enabling the development of more precise and effective treatments.

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DelveInsight's analysis highlights that over 20 companies are actively engaged in developing therapies targeting various aspects of the disease, including B-cell depletion, cytokine inhibition, and immune tolerance restoration. The pipeline includes a diverse array of therapeutic modalities such as monoclonal antibodies, small molecules, peptides, and gene therapies.

Key Takeaways from the Sjogren's Syndrome Pipeline Report
• The Sjogren's syndrome pipeline includes 22+ active drug candidates across multiple stages of development.
• 20+ companies are actively involved in advancing innovative therapies.
• Increasing focus on B-cell targeting and immune modulation is reshaping treatment strategies.
• Novel mechanisms such as BAFF receptor inhibition and dendritic cell modulation are gaining traction.
• Strategic collaborations, licensing deals, and mergers are accelerating pipeline progression.
• Growing emphasis on precision medicine and biomarker-driven approaches is expected to enhance treatment outcomes.
• The pipeline reflects a diverse mix of biologics, small molecules, and advanced therapies.
• In January 2026, Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for Sjögren's disease, the second most prevalent rheumatic autoimmune disease2. Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and inhibits their activation and survival via BAFF-R blockade3. Novartis plans to submit ianalumab for regulatory approval globally starting in early 2026. If approved, ianalumab would become the first targeted treatment for patients with Sjögren's disease.
• In December 2025, Amgen conducted a phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity.
• In December 2025, Novartis Pharmaceuticals announced a study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of the study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly compared to placebo in patients with active Sjogren's syndrome.
• In December 2025, Bristol-Myers Squibb initiated a phase 3 study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
• In August 2025, Novartis was seeking approval for its Sjögren's disease therapy after positive results from two Phase III trials. The NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 (NCT05349214) studies evaluating ianalumab achieved their primary goal of reducing disease activity, as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) compared to placebo. The trials included 749 patients, with NEPTUNUS-1 assessing monthly intravenous ianalumab and NEPTUNUS-2 evaluating the safety and efficacy of subcutaneous ianalumab administered either monthly or every three months.
• In March 2025, Johnson & Johnson announced that the FDA granted Fast Track designation to investigational nipocalimab for treating adult patients with moderate-to-severe Sjögren's disease (SjD), after receiving Breakthrough Therapy designation late last year. No advanced therapies are currently approved for this disease.

Sjogren's Syndrome Emerging Drugs Profile
VAY736 (Ianalumab): Novartis
VAY736, also known as ianalumab, is a first-in-class monoclonal antibody targeting the BAFF receptor, a critical regulator of B-cell survival and activation. By inhibiting BAFF signaling and inducing antibody-dependent cellular cytotoxicity, the drug effectively reduces pathogenic B-cell populations. Its advanced mechanism and promising clinical outcomes position it as a leading candidate in Phase III development.

AMG 329: Amgen
AMG 329 is a fully human monoclonal antibody designed to neutralize FLT3-ligand, thereby reducing dendritic cell populations involved in autoimmune activation. Currently in Phase II trials, the therapy represents a novel approach targeting upstream immune pathways in Sjogren's syndrome.

R-2487: Rise Therapeutics
R-2487 is an oral immune-modulating therapy aimed at restoring immune tolerance by enhancing regulatory T-cell activity. Its unique mechanism addresses underlying immune dysregulation, making it a promising candidate in early-stage clinical development.

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Sjogren's Syndrome Pipeline Segmentation and Therapeutic Assessment
The report provides a comprehensive segmentation of pipeline therapies based on multiple parameters:
Sjogren's Syndrome By Clinical Development Stage
• Phase III (Late-stage)
• Phase II (Mid-stage)
• Phase I (Early-stage)
• Preclinical and Discovery
• Inactive and Discontinued Programs

Sjogren's Syndrome By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Sjogren's Syndrome By Molecule Type
• Monoclonal antibodies
• Small molecules
• Peptides
• Gene therapies
• Recombinant fusion proteins
• Polymer-based therapies

Sjogren's Syndrome By Product Type
• Monotherapy
• Combination therapy
• Mono/Combination approaches
This segmentation underscores the complexity of Sjogren's syndrome and the need for diverse therapeutic strategies.

Sjogren's Syndrome Clinical Trial and Development Activities
The Sjogren's syndrome pipeline is characterized by increasing clinical trial activity across global regions. Companies are actively pursuing partnerships and collaborations to accelerate drug development and expand their research capabilities.

Key players such as Novartis and Bristol-Myers Squibb are leading late-stage development, while emerging biotech firms are exploring innovative approaches targeting immune tolerance and inflammation pathways.

Sjogren's Syndrome Market Drivers, Challenges, and Future Outlook
The growth of the Sjogren's syndrome pipeline is driven by several factors, including increasing disease prevalence, rising awareness, and advancements in autoimmune research. The demand for targeted therapies and personalized medicine is further accelerating innovation.

However, challenges such as disease heterogeneity, lack of standardized diagnostic criteria, and limited biomarkers continue to hinder progress. Addressing these challenges will require collaborative efforts, improved clinical trial design, and integration of advanced technologies such as artificial intelligence.

Looking ahead, the Sjogren's syndrome pipeline is expected to witness significant expansion, with several therapies advancing toward commercialization. Breakthrough innovations in immunotherapy and biologics are likely to redefine treatment paradigms and improve patient outcomes.

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Scope of the Sjogren's Syndrome Pipeline Report
• Coverage: Global
• Key Companies: Novartis, Horizon Therapeutics, Bristol-Myers Squibb, Rise Therapeutics, Resolve Therapeutics, Dompé Farmaceutici, and others
• Key Therapies: VAY736, VIB4920, BMS-986325, R-2487, RSLV-132, Cenegermin
• Therapeutic Assessment: By product type, clinical stage, route of administration, and molecule type

Key Questions Answered
• How many companies are developing Sjogren's syndrome therapies?
• What is the distribution of pipeline drugs across development stages?
• Which mechanisms of action are gaining prominence?
• What collaborations and licensing deals are shaping the market?
• What are the latest clinical trial developments?
• What challenges and opportunities define the future landscape?

Stay Ahead in the Sjogren's Syndrome Market
The Sjogren's syndrome pipeline is rapidly evolving, presenting significant opportunities for stakeholders across the pharmaceutical and healthcare ecosystem. With increasing investment in R&D and a growing focus on targeted therapies, the future of Sjogren's syndrome treatment looks promising.

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.