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scleroderma - Clinical Profile, Genes & Research | Kisho | Kisho

Rare Disease

scleroderma

MONDO:0019340

Also known as:dermatosclerosisscleroderma (disease)

Find Clinical TrialsTrials

Overview

Scleroderma is a rare autoimmune connective tissue disorder characterized by abnormal hardening of the skin and, sometimes, other organs. It is classified into two main forms: localized scleroderma and systemic sclerosis (SSc), the latter comprising three subsets; diffuse cutaneous SSc (dcSSc), limited cutaneous SSc (lcSSc) and limited SSc (lSSc).

TreatmentsNo approved treatments · 2 in pipeline

Clinical Trials73 registered · 29 recruiting

Patient Orgs2 organizations · National Scleroderma Foundation, Scleroderma Research Foundation

Diagnosis

Biomarker and diagnostic research for scleroderma has been reported in the published literature.

Treatment

Compiled from FDA-approved drug records, orphan drug designations, and FDA Adverse Event Reporting System (FAERS) safety data. GeneReviews management guidance is included where available.

No approved treatments are currently available for scleroderma. An additional 2 compounds hold orphan drug designation.

Orphan Drug Designations

While no drugs are FDA-approved specifically for scleroderma, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.

The following drugs have received orphan drug designation from the FDA for scleroderma. Orphan designation reflects regulatory interest and does not indicate approval for treatment.

Brand Name	Generic Name	Sponsor

Prognosis

Estimated prevalence: 1-5 in 10,000 (Uncommon).

Research Landscape

Sourced from ClinicalTrials.gov and PubMed. Publication types are classified using NLM-curated article metadata; research type breakdowns reflect the nature of published work for this disease.

73 clinical trials registered, 29 recruiting. Interventions under study include other interventions, drug therapy, biologic therapy, and procedural interventions. Pipeline includes 2 PHASE4, 2 PHASE3, 11 PHASE2. Research is sponsored by a mix of industry and academic institutions.

NCT ID	Title	Phase	Sponsor	Status
[NCT07182968](https://clinicaltrials.gov/study/NCT07182968)

Data assembled from 5 of 12 sources · Last updated Nov 4, 2026, 4:20 AM UTC

MONDOHPOClinicalTrials.govFDAPubMedHGNCClinVarClinGenGeneReviewsOrphanetOMIMRUSP

Patient Support

Patient Advocacy Groups

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National Scleroderma FoundationPrimary Focus

USWebsite ↗

Scleroderma Research FoundationPrimary Focus

USWebsite ↗

Patient Registry

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Patient Advocacy Groups (PAGs) provide support, resources, and community for patients and caregivers.

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Medical References

External Resources

Orphanet

European rare disease database

Orphanet:801

GARD

Genetic and Rare Diseases Info Center

GARD:18705

Questions for Your Care Team

→Are any of the 73 active clinical trials a good fit for my situation?
→What is the current development status of Sitaxentan (also known as sitaxsentan), and when might it become available?
→Are there specialists or centers of excellence for this condition in my area?
→How can I connect with National Scleroderma Foundation and other patient organizations for support?

← Back to All Diseases

Research Type	Count	% of Total
Research summaries	88	35%
Laboratory research	59	23%
Disease patterns and progression	39	15%
Patient case studies	24	9%
Clinical study results	15	6%
New treatment approaches	15	6%
Testing and diagnosis research	9	4%
Other research	6	2%

Kisho

scleroderma

Overview

Diagnosis

Treatment

Orphan Drug Designations

Prognosis

Research Landscape

Patient Support

Patient Advocacy Groups

Medical References

External Resources

Orphanet

GARD

Questions for Your Care Team

Questions for Your Care Team

Clinical Trials

Recent Publications

Latest News & Developments

Health literacy among people with systemic sclerosis: a scleroderma patient-centred intervention network (SPIN) cohort cross-sectional study.

CAR-T Cell Therapy Moves Beyond Cancer to Autoimmune Diseases | News | Yale Medicine

Enhancing CAR-T Therapy: From Cancer to Autoimmune Diseases | Yale School of Medicine

Navigating the Unknown: Scleroderma Renal Crisis and a Fatal Cardiac Complication in a Young Patient With MCTD With Coexisting Anti-U3 RNP and Anti-RNA Polymerase III Antibodies.

Scleroderma Renal Crisis in Mixed Connective Tissue Disease.

scleroderma

Overview

Diagnosis

Treatment

Orphan Drug Designations

Prognosis

Research Landscape

Patient Support

Patient Advocacy Groups

Medical References

External Resources

Orphanet

GARD

Related Diseases

Questions for Your Care Team

Questions for Your Care Team

Clinical Trials

Recent Publications

Latest News & Developments

Health literacy among people with systemic sclerosis: a scleroderma patient-centred intervention network (SPIN) cohort cross-sectional study.

CAR-T Cell Therapy Moves Beyond Cancer to Autoimmune Diseases | News | Yale Medicine

Enhancing CAR-T Therapy: From Cancer to Autoimmune Diseases | Yale School of Medicine

Navigating the Unknown: Scleroderma Renal Crisis and a Fatal Cardiac Complication in a Young Patient With MCTD With Coexisting Anti-U3 RNP and Anti-RNA Polymerase III Antibodies.

Scleroderma Renal Crisis in Mixed Connective Tissue Disease.