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Drug development in systemic sclerosis: novel therapeutics to watch
Veronica Batani1,2,3, Jelena Colic4,5, Cristina Scaletti6
1Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Hospital, Milano, Italy.
Expert Review of Clinical Immunology
|February 21, 2026
Summary
New therapies for systemic sclerosis (SSc) target immune dysregulation, fibrosis, and vasculopathy. Successful disease modification requires simultaneously addressing inflammation, fibrotic remodeling, and vascular injury.
Area of Science:
- Rheumatology
- Immunology
- Pharmacology
Background:
- Systemic sclerosis (SSc) involves parallel immune dysregulation, fibrosis, and vasculopathy.
- Current understanding highlights the interconnectedness of these pathological domains.
Purpose of the Study:
- To review emerging therapeutic strategies for SSc in clinical development.
- To connect preclinical and translational evidence with ongoing drug development pipelines.
- To illustrate how mechanistic insights are guiding new SSc treatments.
Main Methods:
- Literature search of PubMed/MEDLINE, ClinicalTrials.gov, and EudraCT up to October 2025.
- Focus on English-language publications.
- Synthesis of evidence linking mechanistic insights to therapeutic strategies.
Main Results:
- Emergence of cell-based immunotherapies.
- Development of bispecific antibodies.
- Advancement of next-generation small molecules targeting innate immunity.
Conclusions:
- Novel therapies extend beyond adaptive immunity to modulate innate immunity.
- Effective SSc treatment requires simultaneous interception of inflammation, fibrosis, and vascular injury.
- Mechanistic insights are crucial for reshaping the SSc drug pipeline.
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