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Diffuse Cutaneous Systemic Sclerosis Pipeline

“Diffuse Cutaneous Systemic Sclerosis Pipeline Insight, 2025″report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Diffuse Cutaneous Systemic Sclerosis Market.

The Diffuse Cutaneous Systemic Sclerosis 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.

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Some of the key takeaways from the Diffuse Cutaneous Systemic Sclerosis Pipeline Report:

• DcSSC Companies across the globe are diligently working toward developing novel Diffuse Cutaneous Systemic Sclerosis treatment therapies with a considerable amount of success over the years.
• Key diffuse cutaneous systemic sclerosis companies, including Mitsubishi Tanabe Pharma, Novartis, Cumberland Pharmaceuticals, Johnson & Johnson Innovative Medicine, Kyverna Therapeutics, Kadmon Pharmaceuticals, Talaris Therapeutics, Horizon Therapeutics, Takeda Oncology, Seagen, and others, are actively working on innovative diffuse cutaneous systemic sclerosis drugs.
• Some of the key diffuse cutaneous systemic sclerosis therapies in clinical trials include Dersimelagon (MT-7117), Ianalumab, Vasculan (ifetroban), Guselkumab, KYV 101, FCR 001, Belumosudil, and others. These novel diffuse cutaneous systemic sclerosis therapies are anticipated to enter the diffuse cutaneous systemic sclerosis market in the forecast period and are expected to change the market.
• In July 2025, Novartis began a Phase II multicenter clinical study to assess the effectiveness, safety, and tolerability of Ianalumab in individuals with dcSSc.
• In May 2025, Mitsubishi Tanabe Pharma America announced the completion of enrollment for its Phase III INSPIRE Study of Investigational Dersimelagon in Patients with EPP and XLP.

Diffuse Cutaneous Systemic Sclerosis Overview

Diffuse Cutaneous Systemic Sclerosis (dcSSc) is a severe subtype of systemic sclerosis, a rare autoimmune connective tissue disorder characterized by excessive collagen deposition, vascular dysfunction, and immune system abnormalities. Unlike the limited form, dcSSc involves widespread skin thickening and fibrosis extending beyond the elbows and knees, often affecting internal organs such as the lungs, heart, kidneys, and gastrointestinal tract. This results in significant morbidity and mortality.

The disease is driven by an interplay of genetic, environmental, and immunological factors that lead to endothelial injury and fibroblast activation, promoting fibrosis. Patients typically present with symptoms like Raynaud’s phenomenon, skin tightening, joint stiffness, and digital ulcers. Early disease progression and multiorgan involvement make timely diagnosis and intervention crucial.

Currently, treatment focuses on managing symptoms and slowing disease progression through immunosuppressive agents (e.g., mycophenolate mofetil, cyclophosphamide) and antifibrotic or vasodilatory therapies. Emerging targeted treatments, including monoclonal antibodies and tyrosine kinase inhibitors, are being explored to address the underlying fibrotic mechanisms.

Ongoing research aims to improve early detection, refine patient stratification, and develop disease-modifying therapies, offering hope for better management and outcomes in diffuse cutaneous systemic sclerosis.

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Diffuse Cutaneous Systemic Sclerosis Competitive Landscape

The treatment pipeline for dcSSc reflects a significant unmet medical need. A prominent key player, Mitsubishi Tanabe Pharma (MT-7117), Cumberland Pharmaceuticals (ifetroban), Johnson & Johnson (Guselkumab), Kyverna Therapeutics (KYV-101), and others are currently active in the dcSSc treatment space.

Mitsubishi Tanabe Pharma’s Dersimelagon is an orally administered, synthetic, non-peptide small molecule under development for multiple therapeutic indications. It functions as a selective MC1R agonist, exerting anti-inflammatory, anti-fibrotic, and vascular-protective effects by acting on inflammatory cells, endothelial cells, and fibroblasts. This profile positions it as a potential treatment option for systemic sclerosis. In April 2020, Mitsubishi Tanabe Pharma received Fast Track Designation for MT-7117 for the treatment of diffuse cutaneous systemic sclerosis.

Novartis’ Ianalumab is a novel monoclonal antibody that targets the B-cell activating factor receptor (BAFF-R). It aims to reduce B-cell populations through antibody-dependent cellular cytotoxicity (ADCC) and by blocking survival signals for B cells. Since B cells play a key role in the pathogenesis of diffuse cutaneous systemic sclerosis, including autoantibody production and profibrotic signaling, Ianalumab represents a targeted immunomodulatory strategy.

The anticipated launch of these emerging diffuse cutaneous systemic sclerosis therapies are poised to transform the diffuse cutaneous systemic sclerosis market landscape in the coming years. As these cutting-edge diffuse cutaneous systemic sclerosis therapies continue to mature and gain regulatory approval, they are expected to reshape the diffuse cutaneous systemic sclerosis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Diffuse Cutaneous Systemic Sclerosis Route of Administration

Diffuse Cutaneous 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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Diffuse Cutaneous Systemic Sclerosis Molecule Type

Diffuse Cutaneous Systemic Sclerosis Products have been categorized under various Molecule types, such as

• Oligonucleotide
• Peptide
• Small molecule

Diffuse Cutaneous Systemic Sclerosis Pipeline Therapeutics Assessment

• Diffuse Cutaneous Systemic Sclerosis Assessment by Product Type
• Diffuse Cutaneous Systemic Sclerosis By Stage and Product Type
• Diffuse Cutaneous Systemic Sclerosis Assessment by Route of Administration
• Diffuse Cutaneous Systemic Sclerosis By Stage and Route of Administration
• Diffuse Cutaneous Systemic Sclerosis Assessment by Molecule Type
• Diffuse Cutaneous Systemic Sclerosis by Stage and Molecule Type

DelveInsight’s Diffuse Cutaneous Systemic Sclerosis Report covers around 15+ 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 Diffuse Cutaneous Systemic Sclerosis product details are provided in the report. Download the Diffuse Cutaneous Systemic Sclerosis pipeline report to learn more about the emerging Diffuse Cutaneous Systemic Sclerosis therapies- Diffuse Cutaneous Systemic Sclerosis Competitive Landscape

Diffuse Cutaneous Systemic Sclerosis Pipeline Analysis:

The Diffuse Cutaneous Systemic Sclerosis pipeline report provides insights into

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

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Scope of Diffuse Cutaneous Systemic Sclerosis Pipeline Drug Insight

• Coverage: Global
• Key Diffuse Cutaneous Systemic Sclerosis Companies: Mitsubishi Tanabe Pharma, Novartis, Cumberland Pharmaceuticals, Johnson & Johnson Innovative Medicine, Kyverna Therapeutics, Kadmon Pharmaceuticals, Talaris Therapeutics, Horizon Therapeutics, Takeda Oncology, Seagen, and others.
• Key Diffuse Cutaneous Systemic Sclerosis Therapies: Dersimelagon (MT-7117), Ianalumab, Vasculan (ifetroban), Guselkumab, KYV 101, FCR 001, Belumosudil, and others.
• Diffuse Cutaneous Systemic Sclerosis Therapeutic Assessment: Diffuse Cutaneous Systemic Sclerosis current marketed and Diffuse Cutaneous Systemic Sclerosis emerging therapies
• Diffuse Cutaneous Systemic Sclerosis Market Dynamics: Diffuse Cutaneous Systemic Sclerosis market drivers and Diffuse Cutaneous Systemic Sclerosis market barriers

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Table of Contents

1. Diffuse Cutaneous Systemic Sclerosis Report Introduction

2. Diffuse Cutaneous Systemic Sclerosis Executive Summary

3. Diffuse Cutaneous Systemic Sclerosis Overview:

4. Diffuse Cutaneous Systemic Sclerosis- Analytical Perspective In-depth Commercial Assessment

5. Diffuse Cutaneous Systemic Sclerosis Pipeline Therapeutics

6. Diffuse Cutaneous Systemic Sclerosis Late Stage Products (Phase II/III)

7. Diffuse Cutaneous Systemic Sclerosis Mid Stage Products (Phase II)

8. Diffuse Cutaneous Systemic Sclerosis Early Stage Products (Phase I)

9. Diffuse Cutaneous Systemic Sclerosis Preclinical Stage Products

10. Diffuse Cutaneous Systemic Sclerosis Therapeutics Assessment

11. Diffuse Cutaneous Systemic Sclerosis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Diffuse Cutaneous Systemic Sclerosis Companies

14. Diffuse Cutaneous Systemic Sclerosis Key Products

15. Diffuse Cutaneous Systemic Sclerosis Unmet Needs

16 . Diffuse Cutaneous Systemic Sclerosis Market Drivers and Barriers

17. Diffuse Cutaneous Systemic Sclerosis Future Perspectives and Conclusion

18. Diffuse Cutaneous Systemic Sclerosis Analyst Views

19. Appendix

20. About DelveInsight

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.

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