Sjogren's Disease Pipeline Drugs Report 2025: Promising Drugs and MOA Innovations Reshape Future Treatment Approaches | DelveInsight

DelveInsight's, "Sjogren's Syndrome Pipeline Insight 2025" report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Sjogren's Syndrome pipeline landscape. It covers the Sjogren's Syndrome pipeline drugs profiles, including clinical and nonclinical stage products. It also covers the Sjogren's Syndrome pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Sjogren's Syndrome Pipeline Report

* On 05 November 2025, Janssen Research & Development LLC announced a study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.
* On 04 November 2025, Bristol-Myers Squibb initiated a study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjogren's Syndrome.
* On 03 November 2025, Amgen conducted a phase 3 study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjogren's Syndrome With Moderate-to-severe Systemic Disease Activity.
* On 03 November 2025, Novartis Pharmaceuticals conducted a study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly or every 3 months compared to placebo in patients with active Sjogren's syndrome.
* DelveInsight's Sjogren's Syndrome pipeline report depicts a robust space with 10+ active players working to develop 12+ pipeline therapies for Sjogren's Syndrome treatment.
* The leading Sjogren's Syndrome Companies such as Johnson & Johnson, Novartis, Amgen, Artiva Biotherapeutics, Immunovant Sciences, Astellas Pharma Inc, RemeGen Co., Ltd., Rise Therapeutics LLC, Bristol-Myers Squibb, Argenx, Otsuka Pharmaceutical, Resolve Therapeutics, AbbVie and others.
* Promising Sjogren's Syndrome Pipeline Therapies such as Baricitinib, Hydroxychloroquine, HZN-1116, Nipocalimab, RSLV-132, Lanraplenib, Filgotinib and others.

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Sjogren's Disease Overview

Sjogren's syndrome (SS) is a chronic, systemic autoimmune disease characterized by lymphocytic infiltration and inflammation of exocrine glands, with a primary focus on the salivary and lacrimal glands. This leads to the hallmark features of the condition-xerostomia (dry mouth) and keratoconjunctivitis sicca (dry eyes). The immune system, particularly involving autoreactive T and B lymphocytes, inappropriately targets epithelial tissues, resulting in glandular dysfunction and progressive tissue destruction. Beyond the exocrine glands, SS can also affect the upper respiratory tract, nose, oropharynx, skin, and, leading to widespread mucosal dryness. In addition to sicca symptoms, many patients may experience systemic manifestations such as fatigue, joint pain, myalgia, and involvement of organs like the lungs, kidneys, or nervous system. SS can occur as a primary disorder or secondarily in association with other autoimmune diseases like rheumatoid arthritis or lupus. The chronic inflammation, if left untreated, can significantly impact quality of life and increase the risk of complications, including lymphoma.

Sjogren's Syndrome Emerging Drugs

* VAY736: Novartis

VAY736 (Ianalumab) is a novel, defucosylated, human IgG1/ monoclonal antibody that targets the human B cell-activating factor (BAFF) of the TNF family. The BAFF receptor is predominantly expressed on B cells and is critically involved in B cell maturation, activation, and survival. VAY736 targets the BAFF receptor and competitively inhibits BAFF binding to BAFF-R, thereby blocking BAFF-R-mediated signaling in B cells. It is also engineered to effectively eliminate B cells from circulation in vivo by antibody-dependent cellular cytotoxicity (ADCC). The ADCC activity of ianalumab is greatly enhanced by eliminating fucose residues from the carbohydrate moiety attached to the Fc part of the antibody. The molecule is being developed by Novartis in partnership with MorphoSys as an antibody-based therapy. The drug is currently in Phase III clinical studies for the treatment of Sjogren's Syndrome.

* Nipocalimab: Johnson & Johnson

IMAAVY is a monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies that underlie generalized myasthenia gravis (gMG) without additional detectable effects on other adaptive and innate immune functions. The investigational monoclonal antibody is designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) auto and alloantibodies potentially without additional detectable effects on other adaptive and innate immune functions. The drugs has also been granted Breakthrough Therapy designation for for Sjogren's disease by the US FDA. Currently, the drug is in Phase III stage of its development for the treatment of Sjogren's syndrome.

* Allogeneic NK Cells: Artiva Biotherapeutics

AlloNK is an allogeneic, off-the-shelf, cryopreserved NK cell therapy candidate designed to enhance the ADCC effect of mAbs to drive B-cell depletion. AlloNK, as a non-genetically modified, non-targeted NK cell, is designed to utilize a mAb or NK engager for targeting, and therefore can be used in different combinations against different therapeutic targets. Currently, the drug is in Phase II stage of its development for the treatment of Sjogren's syndrome.

* ASP5502: Astellas Pharma Inc

ASP5502 is an investigational small-molecule drug developed by Astellas Pharma, designed to inhibit the STING (Stimulator of Interferon Genes) pathway, which plays a crucial role in innate immune responses and is implicated in autoimmune conditions like primary Sjogren's syndrome. By targeting this pathway, ASP5502 aims to modulate the immune system's activity, potentially alleviating the chronic inflammation and glandular dysfunction characteristic of the disease. Notably, ASP5502 was identified through Astellas's innovative use of artificial intelligence in drug discovery, highlighting a modern approach to developing treatments for complex autoimmune disorders. Currently, the drug is in Phase I stage of its development for the treatment of Sjogren's syndrome.

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The Sjogren's Syndrome Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Sjogren's Syndrome with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Sjogren's Syndrome Treatment.
* Sjogren's Syndrome Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Sjogren's Syndrome Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Sjogren's Syndrome market

Sjogren's Syndrome Companies

Johnson & Johnson, Novartis, Amgen, Artiva Biotherapeutics, Immunovant Sciences, Astellas Pharma Inc, RemeGen Co., Ltd., Rise Therapeutics LLC, Bristol-Myers Squibb, Argenx, Otsuka Pharmaceutical, Resolve Therapeutics, AbbVie and others.

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Sjogren's syndrome Pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

Sjogren's Disease Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

Scope of the Sjogren's Syndrome Pipeline Report

* Coverage- Global
* Sjogren's Syndrome Companies- Johnson & Johnson, Novartis, Amgen, Artiva Biotherapeutics, Immunovant Sciences, Astellas Pharma Inc, RemeGen Co., Ltd., Rise Therapeutics LLC, Bristol-Myers Squibb, Argenx, Otsuka Pharmaceutical, Resolve Therapeutics, AbbVie and others.
* Sjogren's Syndrome Pipeline Therapies- Baricitinib, Hydroxychloroquine, HZN-1116, Nipocalimab, RSLV-132, Lanraplenib, Filgotinib and others.
* Sjogren's Syndrome Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Sjogren's Syndrome Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* Sjogren's syndrome: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Sjogren's syndrome- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* VAY736: Novartis
* Mid Stage Products (Phase II)
* Allogeneic NK Cells: Artiva Biotherapeutics
* Early Stage Products (Phase I)
* ASP5502: Astellas Pharma Inc
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Inactive Products
* Sjogren's syndrome Key Companies
* Sjogren's syndrome Key Products
* Sjogren's syndrome- Unmet Needs
* Sjogren's syndrome- Market Drivers and Barriers
* Sjogren's syndrome- Future Perspectives and Conclusion
* Sjogren's syndrome Analyst Views
* Sjogren's syndrome Key Companies
* Appendix

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