Sjogren's Syndrome Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Sjogren's Syndrome Pipeline Insight 2025" report provides comprehensive insights about 20+ companies and 22+ 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

* In March 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. Sjogren's syndrome is a chronic, progressive autoimmune disease of unclear etiology typically originating in exocrine glands and capable of affecting the function of almost any organ system in the body.
* In March 2025, Amgen announced a study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS). The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms.
* DelveInsight's Sjogren's Syndrome pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for Sjogren's Syndrome treatment.
* The leading Sjogren's Syndrome Companies such as Novartis, Horizon Therapeutics, Bristol-Myers Squibb, Rise Therapeutics, Resolve Therapeutics, Dompe Farmaceutici, Amgen, Rise Therapeutics 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 Syndrome Emerging Drugs

* VAY736: Novartis

VAY736 (ianalumab) is a novel, intravenous, 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 (SS).

* AMG 329: Amgen

AMG 329 is a fully human monoclonal antibody that binds and neutralizes the function of the FLT3-ligand, thereby reducing both conventional and plasmacytoid dendritic cells. The drug is currently in Phase II clinical studies for the treatment of Sjogren's Syndrome.

* R-2487: Rise Therapeutics

R-2487 is a targeted oral immune therapy that has the ability to induce T regulatory cell populations. R-2487 has a unique mechanism of action by which it can engage specific immune pathways that regulate tolerance and reset T regulatory deficiencies to reduce specific inflammatory cytokines that contribute to autoimmune disease. This mechanism is particularly important in the context of treating autoimmune disease. The drug is currently in Phase I clinical studies for the treatment of Sjogren's Syndrome.

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

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Sjogren's Syndrome Companies

Novartis, Horizon Therapeutics, Bristol-Myers Squibb, Rise Therapeutics, Resolve Therapeutics, Dompe Farmaceutici, Amgen, Rise Therapeutics and others.

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Scope of the Sjogren's Syndrome Pipeline Report

* Coverage- Global
* Sjogren's Syndrome Companies- Novartis, Horizon Therapeutics, Bristol-Myers Squibb, Rise Therapeutics, Resolve Therapeutics, Dompe Farmaceutici, Amgen, Rise Therapeutics 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
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* AMG 329: Amgen
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* R-2487: Rise Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* 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
* 27. Appendix

About Us

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