Sjogren's Syndrome Treatment Pipeline: Comprehensive 2025 Analysis

DelveInsight's "Sjogren's Syndrome Pipeline Insight 2025" analysis delivers extensive perspectives on 10+ organizations and 12+ investigational therapies in the Sjogren's Syndrome pipeline environment. It encompasses Sjogren's Syndrome pipeline drug candidate profiles, spanning clinical and nonclinical development stages. The analysis additionally features Sjogren's Syndrome pipeline treatment evaluation by product classification, developmental phase, administration route, and molecular category. It further spotlights the dormant pipeline assets in this therapeutic domain.

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Essential Highlights from the Sjogren's Syndrome Pipeline Analysis

On 05 November 2025, Janssen Research & Development LLC announced an investigation designed to evaluate the efficacy and safety of nipocalimab in subjects with primary Sjogren's syndrome (pSS) versus placebo.

On 04 November 2025, Bristol-Myers Squibb launched an investigation designed to evaluate the safety and efficacy of two dosing regimens of Deucravacitinib in adult subjects with Active Sjögren's Syndrome.

On 03 November 2025, Amgen initiated a phase 3 investigation to Assess the Efficacy and Safety of Dazodalibep in Subjects With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity.

On 03 November 2025, Novartis Pharmaceuticals initiated an investigation of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in individuals with active Sjogren's syndrome. The objective of this investigation is to establish the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly or every 3 months relative to placebo in individuals with active Sjogren's syndrome.

DelveInsight's Sjogren's Syndrome pipeline analysis reveals a dynamic landscape with 10+ active organizations engaged in advancing 12+ pipeline candidates for Sjogren's Syndrome management.

Prominent Sjogren's Syndrome pharmaceutical developers include 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 among others.

Promising Sjogren's Syndrome Pipeline Treatment Assets include Baricitinib, Hydroxychloroquine, HZN-1116, Nipocalimab, RSLV-132, Lanraplenib, Filgotinib among others.

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Understanding Sjögren's Disease

Sjogren's syndrome (SS) represents a chronic, systemic autoimmune condition distinguished by lymphocytic infiltration and inflammation of exocrine glands, with predominant involvement of the salivary and lacrimal glands. This produces the characteristic features of the disorder—xerostomia (dry mouth) and keratoconjunctivitis sicca (dry eyes). The immune system, predominantly involving autoreactive T and B lymphocytes, inappropriately attacks epithelial tissues, producing glandular dysfunction and progressive tissue destruction. Beyond the exocrine glands, SS can additionally impact the upper respiratory tract, nose, oropharynx, skin, producing widespread mucosal dryness. In addition to sicca manifestations, numerous individuals may experience systemic presentations including fatigue, joint pain, myalgia, and involvement of organs such as the lungs, kidneys, or nervous system. SS can manifest as a primary condition or secondarily in conjunction with other autoimmune diseases such as rheumatoid arthritis or lupus. The chronic inflammation, if unmanaged, can substantially compromise quality of life and elevate the risk of complications, encompassing lymphoma.

Sjogren's Syndrome Investigational Therapeutics

VAY736: Novartis VAY736 (Ianalumab) represents a novel, defucosylated, human IgG1/κ monoclonal antibody that addresses the human B cell-activating factor (BAFF) of the TNF family. The BAFF receptor is predominantly expressed on B cells and is critically implicated in B cell maturation, activation, and survival. VAY736 addresses the BAFF receptor and competitively suppresses BAFF binding to BAFF-R, consequently blocking BAFF-R-mediated signaling in B cells. It is additionally engineered to efficiently eliminate B cells from circulation in vivo through antibody-dependent cellular cytotoxicity (ADCC). The ADCC activity of ianalumab is substantially enhanced by removing fucose residues from the carbohydrate moiety attached to the Fc region of the antibody. The molecule is being advanced by Novartis in collaboration with MorphoSys as an antibody-based treatment. This therapeutic is presently undergoing Phase III clinical investigations for Sjögren's Syndrome management.

Nipocalimab: Johnson & Johnson IMAAVY represents a monoclonal antibody, engineered to bind with elevated affinity to block FcRn and diminish levels of circulating immunoglobulin G (IgG) antibodies that underlie generalized myasthenia gravis (gMG) without additional detectable impacts on other adaptive and innate immune functions. The investigational monoclonal antibody is engineered to bind with elevated affinity to block FcRn and diminish levels of circulating immunoglobulin G (IgG) auto and alloantibodies potentially without additional detectable impacts on other adaptive and innate immune functions. This therapeutic has additionally received Breakthrough Therapy designation for Sjögren's disease from the US FDA. Presently, this therapeutic is undergoing Phase III developmental stage for Sjogren's syndrome management.

Allogeneic NK Cells: Artiva Biotherapeutics AlloNK represents an allogeneic, off-the-shelf, cryopreserved NK cell therapeutic candidate engineered to enhance the ADCC effect of mAbs to facilitate B-cell depletion. AlloNK, as a non-genetically modified, non-targeted NK cell, is engineered to leverage a mAb or NK engager for targeting, and consequently can be utilized in various combinations against different therapeutic targets. Presently, this therapeutic is undergoing Phase II developmental stage for Sjogren's syndrome management.

ASP5502: Astellas Pharma Inc ASP5502 represents an investigational small-molecule agent developed by Astellas Pharma, engineered to inhibit the STING (Stimulator of Interferon Genes) pathway, which fulfills a vital role in innate immune responses and is implicated in autoimmune conditions such as primary Sjögren's syndrome. By addressing this pathway, ASP5502 aims to regulate 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 utilization of artificial intelligence in drug discovery, highlighting a contemporary approach to developing treatments for complex autoimmune disorders. Presently, this therapeutic is undergoing Phase I developmental stage for Sjogren's syndrome management.

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The Sjogren's Syndrome Pipeline Analysis Delivers Perspectives on

The analysis offers comprehensive insights regarding organizations advancing treatments for Sjogren's Syndrome management with aggregate therapeutic candidates developed by individual companies for this indication.

It evaluates various therapeutic assets categorized into initial-stage, intermediate-stage, and advanced-stage development for Sjogren's Syndrome Treatment.

Sjogren's Syndrome pharmaceutical developers engaged in targeted therapeutic advancement with corresponding active and inactive (dormant or terminated) programs.

Sjogren's Syndrome therapeutics under investigation classified by development phase, administration route, target receptor, monotherapy or combination approaches, distinct mechanisms of action, and molecular classification.

Comprehensive examination of partnerships (inter-company collaborations and company-academic institution partnerships), licensing agreements and funding arrangements for future progression of the Sjogren's Syndrome market.

Sjogren's Syndrome Pharmaceutical Developers

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 among others.

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The Sjogren's syndrome Pipeline analysis delivers therapeutic classification of pipeline candidates by Administration Route. Assets have been organized across various administration methods including:

Oral
Intravenous
Subcutaneous
Parenteral
Topical

Sjögren's Disease Assets have been categorized across various Molecular classifications including:

Recombinant fusion proteins
Small molecule
Monoclonal antibody
Peptide
Polymer
Gene therapy

Parameters of the Sjogren's Syndrome Pipeline Analysis

Geographic Coverage: Global

Sjogren's Syndrome Pharmaceutical Organizations: 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 among others.

Sjogren's Syndrome Pipeline Treatment Assets: Baricitinib, Hydroxychloroquine, HZN-1116, Nipocalimab, RSLV-132, Lanraplenib, Filgotinib among others.

Sjogren's Syndrome Treatment Evaluation by Product Classification: Monotherapy, Combination therapy, Monotherapy/Combination therapy

Sjogren's Syndrome Treatment Evaluation by Clinical Phases: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Access the most recent information on Sjogren's Syndrome Treatments and clinical investigations. Download DelveInsight's comprehensive pipeline analysis today! @ Sjogren's Syndrome Companies, Key Products and Unmet Needs

Report Contents

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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