Sjogren's Syndrome Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Sjogren's Syndrome pipeline constitutes 10+ key companies continuously working towards developing 12+ Sjogren's Syndrome treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Sjogren's Syndrome Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Sjogren's Syndrome Market.

The Sjogren's Syndrome Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Sjogren's Syndrome Pipeline Report: https://www.delveinsight.com/sample-request/sjogrens-syndrome-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Sjogren's Syndrome treatment therapies with a considerable amount of success over the years.
• Sjogren's Syndrome companies working in the treatment market are Rise Therapeutics, Bristol-Myers Squibb, Resolve Therapeutics, Novartis, Horizon Therapeutics, Dompe Farmaceutici, Horizon Therapeutics (Amgen), Sylentis, OSE Immunotherapeutics, Servier, Johnson & Johnson, and others, are developing therapies for the Sjogren's Syndrome treatment
• Emerging Sjogren's Syndrome therapies in the different phases of clinical trials are- R-2487, BMS-986325, RSLV-132, CFZ533, VIB4920, VAY736, Dazodalibep (VIB4920), OXERVATE (cenegermin), Tivanisiran (SYL1001), Lusvertikimab (formerly OSE-127), Nipocalimab, and others are expected to have a significant impact on the Sjogren's Syndrome market in the coming years.
• In March 2025, Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to its investigational therapy, nipocalimab, for treating adults with moderate-to-severe Sjögren's disease (SjD). This follows the Breakthrough Therapy designation (BTD) received for the same therapy late last year. Presently, there are no advanced treatments approved specifically for this condition.
• In November 2024, Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to nipocalimab for treating adults with moderate-to-severe Sjögren's disease (SjD), a chronic autoantibody condition with significant prevalence and no approved advanced treatments available. Nipocalimab is the first investigational therapy to receive this designation for SjD. This marks the second BTD granted for nipocalimab, following the February designation for treating alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).
• In June 2024, Johnson & Johnson reported results from the Phase II DAHLIAS dose-ranging study, where its monoclonal antibody nipocalimab showed significant improvements in Sjögren's disease (SjD) activity in patients. DAHLIAS is a randomized, multicenter, placebo-controlled, double-blind trial that assessed the effects of nipocalimab in adults with primary SjD, a chronic and debilitating autoimmune disorder.

Sjogren's Syndrome Overview
Sjögren's syndrome is a chronic autoimmune disorder that primarily affects the glands that produce saliva and tears. In this syndrome, the immune system mistakenly attacks and damages the glands, leading to a reduction in the production of saliva and tears. While it most commonly affects the salivary and lacrimal (tear) glands, it can also impact other organs and systems in the body.

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Emerging Sjogren's Syndrome Drugs Under Different Phases of Clinical Development Include:
• R-2487: Rise Therapeutics
• BMS-986325: Bristol-Myers Squibb
• RSLV-132: Resolve Therapeutics
• CFZ533: Novartis
• VIB4920: Horizon Therapeutics
• VAY736: Novartis
• Dazodalibep (VIB4920): Horizon Therapeutics (Amgen)
• OXERVATE (cenegermin): Dompe Farmaceutici
• Tivanisiran (SYL1001): Sylentis
• Lusvertikimab (formerly OSE-127): OSE Immunotherapeutics/Servier
• Nipocalimab: Johnson & Johnson

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

Sjogren's Syndrome Molecule Type
Sjogren's Syndrome Products have been categorized under various Molecule types, such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Sjogren's Syndrome Pipeline Therapeutics Assessment
• Sjogren's Syndrome Assessment by Product Type
• Sjogren's Syndrome By Stage and Product Type
• Sjogren's Syndrome Assessment by Route of Administration
• Sjogren's Syndrome By Stage and Route of Administration
• Sjogren's Syndrome Assessment by Molecule Type
• Sjogren's Syndrome by Stage and Molecule Type

DelveInsight's Sjogren's Syndrome Report covers around 12+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Sjogren's Syndrome product details are provided in the report. Download the Sjogren's Syndrome pipeline report to learn more about the emerging Sjogren's Syndrome therapies
https://www.delveinsight.com/sample-request/sjogrens-syndrome-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Sjogren's Syndrome Therapeutics Market include:
Key companies developing therapies for Sjogren's Syndrome are - Novartis, Johnson & Johnson, Dompe Farmaceutici, Sylentis, MorphoSys, Resolve Therapeutics, OSE Immunotherapeutics, Horizon Therapeutics (Amgen), Servier, and others.

Sjogren's Syndrome Pipeline Analysis:
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 key 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.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Sjogren's Syndrome drugs and therapies
https://www.delveinsight.com/sample-request/sjogrens-syndrome-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Sjogren's Syndrome Pipeline Market Drivers
• Increasing Prevalence, development of better Classification Criteria, increased research and development are some of the important factors that are fueling the Sjogren's Syndrome Market.

Sjogren's Syndrome Pipeline Market Barriers
• However, lack of specific therapeutic approaches, limited translation of Therapies into the real world and other factors are creating obstacles in the Sjogren's Syndrome Market growth.

Scope of Sjogren's Syndrome Pipeline Drug Insight
• Coverage: Global
• Key Sjogren's Syndrome Companies: Rise Therapeutics, Bristol-Myers Squibb, Resolve Therapeutics, Novartis, Horizon Therapeutics, Dompe Farmaceutici, Horizon Therapeutics (Amgen), Sylentis, OSE Immunotherapeutics, Servier, Johnson & Johnson, and others
• Key Sjogren's Syndrome Therapies: R-2487, BMS-986325, RSLV-132, CFZ533, VIB4920, VAY736, Dazodalibep (VIB4920), OXERVATE (cenegermin), Tivanisiran (SYL1001), Lusvertikimab (formerly OSE-127), Nipocalimab, and others
• Sjogren's Syndrome Therapeutic Assessment: Sjogren's Syndrome current marketed and Sjogren's Syndrome emerging therapies
• Sjogren's Syndrome Market Dynamics: Sjogren's Syndrome market drivers and Sjogren's Syndrome market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

This release was published on openPR.