Scleroderma Pipeline: Pioneering Progress with 40+ Leading Companies Developing Groundbreaking Therapies | DelveInsight

The Scleroderma market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as Certa Therapeutics, Argenx, Cumberland Pharmaceuticals, Sanofi, Amgen, Genentech, Cabaletta Bio, and Kyverna Therapeutics. These industry pioneers are transforming treatment strategies and redefining the future of Scleroderma, bringing new hope to patients worldwide.

DelveInsight's "Scleroderma Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Scleroderma market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Scleroderma drugs, the Scleroderma pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Scleroderma Pipeline Report
• DelveInsight's Scleroderma Pipeline analysis depicts a robust space with 40+ active players working to develop 50+ pipeline drugs for Scleroderma treatment.
• The leading Scleroderma companies include 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 are evaluating their lead assets to improve the Scleroderma treatment landscape.
• Key Scleroderma pipeline therapies in various stages of development include LUMICEF (Brodalumab), BENLYSTA (Belimumab), SAPHNELO (Anifrolumab), UPLIZNA (Inebilizumab), VIXARELIMAB (RG6536), AVENCIGUAT (BI 685509), DERSIMELAGON (MT-7117), EFZOFITIMOD, FIPAXALPARANT, VASCULAN (Ifetroban), Inebilizumab, HZN-825, MT-7117, RO7303509, Soquelitinib, and others.
• In February 2025, the FDA cleared Allogene Therapeutics' investigational new drug (IND) application for ALLO-329, an allogenic CAR-T cell therapy. Researchers are set to begin the Phase 1 RESOLUTION trial in mid-2025 for autoimmune diseases, including systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathies, and systemic sclerosis.
• In April 2024, BLR Bio received the designation for BLR-200, a therapy emerging from Rosalind Franklin University's Helix 51 biomedical incubator
• In September 2024, Aisa Pharma secured orphan drug status for AISA-021 (cilnidipine), a fourth-generation calcium channel antagonist aimed at treating systemic sclerosis, a condition affecting approximately 175,000 Americans.
• In October 2023, Kyverna Therapeutics received FDA clearance for its third IND application for KYV-101, an autologous anti-CD19 CAR T-cell therapy. The company is set to launch a Phase 1/2 multicenter study evaluating KYV-101 for diffuse cutaneous systemic sclerosis (dcSSc).

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Scleroderma Overview
Scleroderma, or systemic sclerosis, is a rare autoimmune connective tissue disease characterized by progressive skin and organ fibrosis due to excessive collagen production. Its pathogenesis involves immune dysregulation, vascular abnormalities, and fibrosis, leading to complications in the lungs, heart, kidneys, and gastrointestinal tract. The disease manifests in two main forms: limited cutaneous systemic sclerosis (lcSSc), which primarily affects the hands, face, and distal extremities, and diffuse cutaneous systemic sclerosis (dcSSc), which involves more extensive skin thickening and severe internal organ involvement.

Common symptoms include Raynaud's phenomenon, skin hardening, telangiectasia (dilated blood vessels), calcinosis, and gastrointestinal issues. While the exact cause is unclear, genetic predisposition (HLA and non-HLA genes) and environmental factors (viral infections, silica, organic solvents) are believed to play a role. The disease is more prevalent in women, possibly due to hormonal influences.

There is no cure for scleroderma, and treatment focuses on symptom management and preventing complications. Immunosuppressive therapies, such as mycophenolate mofetil, methotrexate, and cyclophosphamide, help control skin and organ involvement. In severe cases, autologous hematopoietic stem cell transplantation may be considered. Pulmonary complications, such as interstitial lung disease and pulmonary hypertension, require targeted treatments like mycophenolate mofetil, bosentan, and sildenafil. A multidisciplinary approach, including medications, physical therapy, and supportive care, is essential to improve patients' quality of life.

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Scleroderma Treatment Analysis: Drug Profile
Inebilizumab (MEDI-551): Mitsubishi Tanabe Pharma Corporation
Inebilizumab is a humanized anti-CD19 monoclonal antibody designed to target and deplete B cells through antibody-dependent, cell-mediated cytotoxicity. By binding to CD19, a key regulator of B-cell signaling, the therapy aims to modulate immune responses in scleroderma. It is currently in Phase III clinical trials for the condition.

HZN-825 (Fipaxalparant): Amgen
HZN-825 is a small-molecule LPAR1 antagonist being investigated for diffuse cutaneous systemic sclerosis (dcSSc). By acting as a negative allosteric modulator of lysophosphatidic acid receptor 1 (LPAR1), it aims to counteract fibrotic processes. The drug is currently in Phase II clinical development for scleroderma.

MT-7117 (Dersimelagon): Mitsubishi Tanabe Pharma America Inc.
MT-7117 is an oral selective melanocortin-1 receptor (MC1R) agonist with anti-inflammatory, antifibrotic, and vasoprotective effects. It has demonstrated disease-modifying potential in preclinical models of systemic sclerosis (SSc) by reducing inflammation, vascular dysfunction, and fibrosis. Currently, it is in Phase II clinical trials for the treatment of scleroderma.

Key Scleroderma Therapies and Companies
• LUMICEF (Brodalumab): Kyowa Kirin
• BENLYSTA (Belimumab): GSK
• SAPHNELO (Anifrolumab): AstraZeneca
• UPLIZNA (Inebilizumab): Amgen (Horizon Therapeutics)/Mitsubishi Tanabe Pharma
• VIXARELIMAB (RG6536): Roche (Genentech)/Kiniksa Pharmaceuticals
• AVENCIGUAT (BI 685509): Boehringer Ingelheim
• DERSIMELAGON (MT-7117): Mitsubishi Tanabe Pharma
• EFZOFITIMOD: aTyr Pharma/Kyorin Pharmaceutical
• FIPAXALPARANT: Amgen (Horizon Therapeutics)
• VASCULAN (Ifetroban): Cumberland Pharmaceuticals
• Inebilizumab: Mitsubishi Tanabe Pharma Corporation
• HZN-825: Amgen
• MT-7117: Mitsubishi Tanabe Pharma America Inc.
• RO7303509: Genentech, Inc.
• Soquelitinib: Corvus Pharmaceuticals

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Scleroderma Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Scleroderma Pipeline Report
• Coverage: Global
• Key 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.
• Key Scleroderma Pipeline Therapies: LUMICEF (Brodalumab), BENLYSTA (Belimumab), SAPHNELO (Anifrolumab), UPLIZNA (Inebilizumab), VIXARELIMAB (RG6536), AVENCIGUAT (BI 685509), DERSIMELAGON (MT-7117), EFZOFITIMOD, FIPAXALPARANT, VASCULAN (Ifetroban), Inebilizumab, HZN-825, MT-7117, RO7303509, Soquelitinib, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Scleroderma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Scleroderma Pipeline Therapeutics
6. Scleroderma Pipeline: Late-Stage Products (Phase III)
7. Scleroderma Pipeline: Late-Stage Products (Phase III)
8. Scleroderma Pipeline: Mid-Stage Products (Phase II)
9. Scleroderma Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

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This release was published on openPR.