DelveInsight’s, “Scleroderma Pipeline Insight 2025” report provides comprehensive insights about 40+ companies and 50+ pipeline drugs in Scleroderma pipeline landscape. It covers the Scleroderma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Scleroderma 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 Scleroderma Pipeline Report
- In July 2025, Boehringer Ingelheim announced a study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma.
- In July 2025, Janssen Pharmaceutical K.K. announced a study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).
- In July 2025, AstraZeneca announced a 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.
- DelveInsight’s Scleroderma pipeline report depicts a robust space with 40+ active players working to develop 50+ pipeline therapies for Scleroderma treatment.
- The leading Scleroderma Companies such as AstraZeneca, Mitsubishi Tanabe Pharma Corporation, GlaxoSmithKline, Boehringer Ingelheim, Novartis Pharmaceuticals, Certa Therapeutics, Argenx, Cumberland Pharmaceuticals, Sanofi, Amgen, Genentech, Inc., Cabaletta Bio, Kyverna Therapeutics, ChemomAb Ltd., Corvus Pharmaceuticals, Quoin Pharmaceuticals Ltd., aTyr Pharma, APIE Therapeutics, 4P Pharma, Rubedo Life Sciences, Inc., Nobelpharma Co., Ltd., The Scripps Research Institute and others.
- Promising Scleroderma Pipeline Therapies such as Divozilimab, C-82 Topical Gel, 1%, Dasatinib, imatinib mesylate, Abatacept, Avenciguat (BI 685509), GSK2330811, Nintedanib, FT011 and others.
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Scleroderma Emerging Drugs Profile
- Inebilizumab: Mitsubishi Tanabe Pharma Corporation
Inebilizumab, also callled MEDI-551 is a humanized, anti-CD19 monoclonal antibody that binds to CD19, leading to antibody-dependent, cell-mediated cytotoxicity of B cells. CD19 is involved in B-cell signaling, intervening in the balance between humoral, antigen-induced response and tolerance induction. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Scleroderma.
- HZN-825: Amgen
HZN-825 (Fipaxalparant) is a molecule that blocks lysophosphatidic acid receptor 1 (LPAR1). It is being investigated for the treatment of diffuse cutaneous systemic sclerosis. It is a small molecule acting as a negative allosteric modulator of LPAR1. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Scleroderma.
- MT-7117: Mitsubishi Tanabe Pharma America Inc.
Dersimelagon (MT-7117), a novel synthetic, oral, selective melanocortin-1 receptor agonist, demonstrated disease-modifying effects in preclinical models of systemic sclerosis (SSc). MT-7117 reduces inflammation, vascular dysfunction, and fibrosis through its pleiotropic effects on inflammatory cells, endothelial cells, and fibroblastsis, and is as a potential therapeutic agent for the treatment of SSc. Currently, the drug is in the Phase II stage of development to treat Scleroderma.
- RO7303509: Genentech, Inc.
RG-6315 (RO-7303509) is under development for the treatment of inflammation, fibrosis and systemic sclerosis. The drug candidate is administered through subcutaneous or intravenous routes. It is a new molecular entity (NME). Currently, the drug is in the Phase I stage of development to treat Scleroderma.
- Soquelitinib: Corvus Pharmaceuticals
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function.. Currently, the drug is in the Preclinical stage of development to treat Scleroderma.
The Scleroderma Pipeline Report Provides Insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of Scleroderma 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 Scleroderma Treatment.
- Scleroderma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- Scleroderma 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 Scleroderma market
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Scleroderma Companies
AstraZeneca, Mitsubishi Tanabe Pharma Corporation, GlaxoSmithKline, Boehringer Ingelheim, Novartis Pharmaceuticals, Certa Therapeutics, Argenx, Cumberland Pharmaceuticals, Sanofi, Amgen, Genentech, Inc., Cabaletta Bio, Kyverna Therapeutics, ChemomAb Ltd., Corvus Pharmaceuticals, Quoin Pharmaceuticals Ltd., aTyr Pharma, APIE Therapeutics, 4P Pharma, Rubedo Life Sciences, Inc., Nobelpharma Co., Ltd., The Scripps Research Institute and others.
Scleroderma 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
Scleroderma Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
Unveil the future of Scleroderma Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Scleroderma Market Drivers and Barriers
Scope of the Scleroderma Pipeline Report
- Coverage- Global
- Scleroderma Companies- AstraZeneca, Mitsubishi Tanabe Pharma Corporation, GlaxoSmithKline, Boehringer Ingelheim, Novartis Pharmaceuticals, Certa Therapeutics, Argenx, Cumberland Pharmaceuticals, Sanofi, Amgen, Genentech, Inc., Cabaletta Bio, Kyverna Therapeutics, ChemomAb Ltd., Corvus Pharmaceuticals, Quoin Pharmaceuticals Ltd., aTyr Pharma, APIE Therapeutics, 4P Pharma, Rubedo Life Sciences, Inc., Nobelpharma Co., Ltd., The Scripps Research Institute and others.
- Scleroderma Pipeline Therapies- Divozilimab, C-82 Topical Gel, 1%, Dasatinib, imatinib mesylate, Abatacept, Avenciguat (BI 685509), GSK2330811, Nintedanib, FT011 and others.
- Scleroderma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Scleroderma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
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Table of Contents
- Introduction
- Executive Summary
- Scleroderma: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Scleroderma– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Inebilizumab: Mitsubishi Tanabe Pharma Corporation
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- HZN-825: Amgen
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- RO7303509: Genentech, Inc.
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Soquelitinib: Corvus Pharmaceuticals
- Drug profiles in the detailed report…..
- Inactive Products
- Scleroderma Key Companies
- Scleroderma Key Products
- Scleroderma- Unmet Needs
- Scleroderma- Market Drivers and Barriers
- Scleroderma- Future Perspectives and Conclusion
- Scleroderma Analyst Views
- Scleroderma Key Companies
- Appendix
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