Systemic Sclerosis Pipeline Shows Strong Momentum as 50+ Pharma Companies in the Race | DelveInsight

DelveInsight's, "Systemic Sclerosis Pipeline Insight 2026" report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Systemic Sclerosis pipeline landscape. It covers the Systemic Sclerosis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Systemic Sclerosis 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 Systemic Sclerosis Pipeline Report
• On July 23, 2026- AstraZeneca initiated a phase III study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.
• On July 22, 2026- Cabaletta Bio conducted a phase 1/2 study is being conducted to evaluate the safety and efficacy of an investigational therapy, CABA-201, a CD19-CAR T cell therapy, that can be given to patients with SSc who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.
• On July 20, 2026- Zura Bio Inc. announced a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2).
• On July 21, 2026- argenx initiated a phase 2 study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.
• DelveInsight's Systemic Sclerosis Pipeline report depicts a robust space with 50+ active players working to develop 50+ pipeline therapies for Systemic Sclerosis treatment.
• The leading Systemic Sclerosis Companies such as Eicos Sciences, Beijing Continent Pharmaceutical, Kyowa Kirin, Cytori Therapeutics, Corbus Pharmaceuticals, Zenyaku Kogyo, Sanofi, Bayer, ASKA Pharmaceutical, Emerald Health Pharmaceuticals, United Therapeutics, Cumberland Pharmaceuticals, ILTOO Pharma, Horizon Pharmaceuticals, Janssen Biotech, Gesynta Pharma, Certa Therapeutics, Pfizer, Vicore Pharma, Seagen, CSL Behring, arGentis Pharmaceuticals, Mitsubishi Tanabe Pharma, Kadmon Pharmaceuticals, GlaxoSmithKline, Bristol-Myers Squibb, Camurus, Regeneron Pharmaceuticals, Castle Creek Biosciences, Talaris Therapeutics, Viela Bio, Formation Biologics, Horizon Therapeutics, Chemomab Therapeutics, AnaMar, Atlantic Healthcare, D&D Pharmatech, Acceleron Pharma, Riptide Bioscience, Timber Pharmaceuticals, Tvardi Therapeutics, Accuitis Pharmaceuticals, AKL Research and Development, iBio, Blade Therapeutics, Cantargia, BriaCell Therapeutics, Leadiant Biosciences and others.
• Promising Systemic Sclerosis Pipeline Therapies such as Divozilimab, Avenciguat (BI 685509), Nintedanib, GSK2330811, Riociguat (Adempas, BAY63-2521), Bosentan, Imatinib mesylate, Belimumab, Rituximab, and others.

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Systemic Sclerosis Overview
Scleroderma, also known as Systemic Sclerosis, progressive systemic sclerosis or the CREST syndrome, is a chronic skin disorder that affects the skin, connective tissues and other internal organs. The disorder takes place sin humans, when the immune system causes the body to make the protein collagen, an important component of the skin, in huge amounts. Scleroderma is considered to be a rare disorder with an estimated prevalence of 276-300 cases per million, in United States and an incidence rate of about 20 cases per million per year. The systemic sclerosis is segmented into two subsets depending on the extent of skin involvement-localized scleroderma and systemic scleroderma. The most common sign that is observed in scleroderma is the Raynaud's phenomenon, a clinical problem that is associated with cold and stress induced vasospasm of the digital arteries and cutaneous arterioles that are involved within the body's thermoregulation. There is no particular test that is recommended in scleroderma for diagnosis. It is a clinical diagnosis which needs a thorough examination and history. Currently there is no cure that has been observed for scleroderma. Instead the treatment by a dermatologist focusses on the control and management of symptoms. As scleroderma tends to have many symptoms, a combinational approach might often be required for the treatment and management of symptoms in an effective manner.

Systemic Sclerosis Emerging Drugs Profile
• Iloprost: Eicos Sciences
Iloprost is a stable analogue of PGI2 and a potent prostacyclin (IP) receptor agonist. By mimicking PGI2, it is a vasodilator and inhibitor of platelet activation and fibrosis. Iloprost stimulates generation of cAMP by binding to the IP receptor, thereby affecting phospholipase activity and cytosolic calcium levels in platelets, fibroblasts, and endothelial cells. It is a potent vasodilator and platelet inhibitor with anti-inflammatory and anti-fibrotic effects being developed and investigated in Phase III stage of development for the treatment of digital ischemic episodes in people with Systemic Sclerosis (SSc).

• ECCS 50: Cytori therapeutics
ECCS-50 (Cytori stem cell therapy) is a new treatment intended for the treatment of moderate to severe hand problems in people with scleroderma. It involves taking stem cells (a cell with the potential to become any cell type) from patient's fat tissue and reinjecting these cells into the hands. ECCS 50 are adipose derived stem and regenerative cells (ADRCs) taken from the patient's own tissue and prepared using Cytori's cellulation system before administration. ADRCs can be used to repair and regenerate a range of damaged or diseased tissue types by differentiation of the ASRCs along the specific cell lineage, thereby replacing the damaged or missing tissue.

• Lenabasum (JBT-101): Corbus Pharmaceuticals
Lenabasum is a novel, oral, small molecule designed to provide an alternative to immunosuppressive treatments for inflammatory or fibrotic diseases. Lenabasum binds to and activates the receptor type 2 (CB2), which is preferentially expressed on activated immune cells, to resolve inflammation and limit fibrosis. Data from animal models and human clinical studies suggest that lenabasum can reduce expression of genes and proteins involved in inflammation and fibrosis. In clinical testing to date, lenabasum has acceptable safety and tolerability profiles without evidence of immunosuppression.

• EHP-101: Emerald Health Pharmaceuticals
EHP-101 is an oral formulation of VCE-004.8, a synthetic aminoquinone derivative with dual peroxisome proliferator-activated receptor gamma (PPARγ) and receptor type 2 (CB2) agonist activity. Both receptors are therapeutic targets for SSc. EHP-101 also modulates the hypoxia inducible factor (HIF) pathway, expanding the rationale for its development as a novel SSc drug. It is currently in phase II stage of development and is being developed by Emerald Health Pharmaceuticals.

The Systemic Sclerosis Pipeline Report Provides Insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Systemic Sclerosis 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 Systemic Sclerosis Treatment.
• Systemic Sclerosis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Systemic Sclerosis 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 Systemic Sclerosis market

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Systemic Sclerosis Companies
Eicos Sciences, Beijing Continent Pharmaceutical, Kyowa Kirin, Cytori Therapeutics, Corbus Pharmaceuticals, Zenyaku Kogyo, Sanofi, Bayer, ASKA Pharmaceutical, Emerald Health Pharmaceuticals, United Therapeutics, Cumberland Pharmaceuticals, ILTOO Pharma, Horizon Pharmaceuticals, Janssen Biotech, Gesynta Pharma, Certa Therapeutics, Pfizer, Vicore Pharma, Seagen, CSL Behring, arGentis Pharmaceuticals, Mitsubishi Tanabe Pharma, Kadmon Pharmaceuticals, GlaxoSmithKline, Bristol-Myers Squibb, Camurus, Regeneron Pharmaceuticals, Castle Creek Biosciences, Talaris Therapeutics, Viela Bio, Formation Biologics, Horizon Therapeutics, Chemomab Therapeutics, AnaMar, Atlantic Healthcare, D&D Pharmatech, Acceleron Pharma, Riptide Bioscience, Timber Pharmaceuticals, Tvardi Therapeutics, Accuitis Pharmaceuticals, AKL Research and Development, iBio, Blade Therapeutics, Cantargia, BriaCell Therapeutics, Leadiant Biosciences and others.

Systemic Sclerosis 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.
• Molecule Type

Systemic Sclerosis Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type

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Scope of the Systemic Sclerosis Pipeline Report
• Coverage- Global
• Systemic Sclerosis Companies- Eicos Sciences, Beijing Continent Pharmaceutical, Kyowa Kirin, Cytori Therapeutics, Corbus Pharmaceuticals, Zenyaku Kogyo, Sanofi, Bayer, ASKA Pharmaceutical, Emerald Health Pharmaceuticals, United Therapeutics, Cumberland Pharmaceuticals, ILTOO Pharma, Horizon Pharmaceuticals, Janssen Biotech, Gesynta Pharma, Certa Therapeutics, Pfizer, Vicore Pharma, Seagen, CSL Behring, arGentis Pharmaceuticals, Mitsubishi Tanabe Pharma, Kadmon Pharmaceuticals, GlaxoSmithKline, Bristol-Myers Squibb, Camurus, Regeneron Pharmaceuticals, Castle Creek Biosciences, Talaris Therapeutics, Viela Bio, Formation Biologics, Horizon Therapeutics, Chemomab Therapeutics, AnaMar, Atlantic Healthcare, D&D Pharmatech, Acceleron Pharma, Riptide Bioscience, Timber Pharmaceuticals, Tvardi Therapeutics, Accuitis Pharmaceuticals, AKL Research and Development, iBio, Blade Therapeutics, Cantargia, BriaCell Therapeutics, Leadiant Biosciences and others.
• Systemic Sclerosis Pipeline Therapies- Divozilimab, Avenciguat (BI 685509), Nintedanib, GSK2330811, Riociguat (Adempas, BAY63-2521), Bosentan, Imatinib mesylate, Belimumab, Rituximab, and others.
• Systemic Sclerosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Systemic Sclerosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content
1. Introduction
2. Executive Summary
3. Systemic Sclerosis: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Late Stage Products (Phase III)
7. Iloprost: Eicos Sciences
8. Drug profiles in the detailed report.....
9. Mid Stage Products (Phase II)
10. EHP-101: Emerald Health Pharmaceuticals
11. Drug profiles in the detailed report.....
12. Early stage products (Phase I)
13. VIB7734: Viela Bio
14. Drug profiles in the detailed report.....
15. Inactive Products
16. Systemic Sclerosis Key Companies
17. Systemic Sclerosis Key Products
18. Systemic Sclerosis- Unmet Needs
19. Systemic Sclerosis- Market Drivers and Barriers
20. Systemic Sclerosis- Future Perspectives and Conclusion
21. Systemic Sclerosis Analyst Views
22. Systemic Sclerosis Key Companies
23. Appendix

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