Sjogren's Syndrome - Pipeline Insight, 2025

This “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 pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Sjogren’s syndrome: Understanding

Sjogren’s syndrome: 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, in women, the vaginal mucosa, 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 (SS) is primarily categorized into two types: primary SS and secondary SS. Primary SS occurs as an independent autoimmune condition, without the presence of another underlying systemic rheumatic disease. In contrast, secondary SS is associated with other established autoimmune disorders, most commonly systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), or scleroderma. This classification helps in understanding the disease context and tailoring management strategies. However, the distinction between primary and secondary SS is still under discussion, as overlapping clinical features and shared immunologic pathways often make clear differentiation challenging. Additionally, current diagnostic criteria lack universally accepted standards to reliably distinguish between these subtypes, leading to ongoing debate in the medical community.

The characteristic lesion of Sjogren syndrome is focal lymphocytic sialadenitis (FLS). FLS is a lesion of the exocrine glands. Foci of lymphocyte-rich mononuclear cells infiltrate exocrine glandular tissue adjacent to blood vessels and excretory ducts. The foci are comprised predominantly of T lymphocytes. However, B lymphocytes, plasma cells, and other cell types are seen. With a more severe disease, the foci may become confluent. The infiltrating mononuclear cells, humoral factors such as antibodies and cytokines, or both, are hypothesized to cause exocrine gland dysfunction resulting in diminished tear production by the lacrimal glands and diminished saliva production by the salivary glands. Also, exocrine glands outside the head and neck may be involved resulting in skin, tracheobronchial and vaginal dryness as well as lung and kidney dysfunction. Rarely, the malignant transformation of B lymphocytes can result in non-Hodgkin lymphoma. Immune complexes may deposit in skin, joints, and other organs, resulting in a systemic vasculitis.

While there is no cure for Sjogren's syndrome, treatment focuses on relieving symptoms and preventing complications. Options include the use of artificial tears and saliva substitutes to manage dryness, medications such as anti-inflammatory drugs for joint pain, immunosuppressive drugs to reduce the immune response, and pilocarpine or cevimeline to stimulate saliva production. Good oral hygiene is crucial to prevent dental problems. Additionally, lifestyle changes like staying hydrated, using humidifiers, and avoiding medications that can worsen dryness are recommended.

"Sjogren’s syndrome - Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sjogren’s syndrome pipeline landscape is provided which includes the disease overview and Sjogren’s syndrome treatment guidelines. The assessment part of the report embraces, in depth Sjogren’s syndrome commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sjogren’s syndrome collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights
The companies and academics are working to assess challenges and seek opportunities that could influence Sjogren’s syndrome R&D. The therapies under development are focused on novel approaches to treat/improve Sjogren’s syndrome.

Sjogren’s syndrome Emerging Drugs Chapters

This segment of the Sjogren’s syndrome report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Sjogren’s syndrome Emerging Drugs

VAY736: Novartis

VAY736 (Ianalumab) is a novel, defucosylated, human IgG1/κ 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 Sjögren’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 Sjögren’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 Sjögren’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.

Sjogren’s syndrome: Therapeutic Assessment

This segment of the report provides insights about the different Sjogren’s syndrome drugs segregated based on following parameters that define the scope of the report.

Major Players in Sjogren’s syndrome

• There are approx. 10+ key companies which are developing the therapies for Sjogren’s syndrome. The companies which have their Sjogren’s syndrome drug candidates in the most advanced stage, i.e. Phase II include, ILiAD Biotechnologies.

Phases
The 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) along with the details of:
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type
Products have been categorized under various Molecule types, such as:

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

Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Sjogren’s syndrome: Pipeline Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Sjogren’s syndrome therapeutic drugs key players involved in developing key drugs.

Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sjogren’s syndrome drugs.

Sjogren’s syndrome Report Insights

• Sjogren’s syndrome Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Sjogren’s syndrome Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Sjogren’s syndrome drugs?
• How many Sjogren’s syndrome drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Sjogren’s syndrome?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Sjogren’s syndrome therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Sjogren’s syndrome and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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

Key Products

• Nipocalimab
• VAY736
• VIB4920
• Allogeneic NK Cells
• IMVT-1402
• ASP5502
• Telitacicept
• R-2487
• Deucravacitinib
• Efgartigimod
• Sibeprenlimab
• RSLV-132
• ABBV-319

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