Summary
Cyclosporine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Myopathies (Dermatomyositis / PM / IBM) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Myopathies (Dermatomyositis / PM / IBM). ClinicalTrials.gov lists 4 registered trials linking Cyclosporine to Inflammatory Myopathies (Dermatomyositis / PM / IBM): 1 is currently recruiting; 1 is active or not yet recruiting; 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00323960). It plans or enrolled 139 participants. Registration activity spans 2006 to 2025. The literature layer holds 4 publications for this pair: 2 Cochrane reviews, 1 meta-analysis and 1 systematic review. Publication years run from 2019 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Dermatomyositis ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous remission in ~10-15% over 2 years without treatment; IBM (inclusion body myositis) is slowly progressive with no effective treatment; death from interstitial lung disease in dermatomyositis in 5-10%.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 49.5 (trials 12.5, literature 17.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 1 recruiting, 1 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 4 (2 Cochrane reviews, 1 meta-analysis, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | CD80 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00323960 | Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis 2006 | completed | Phase 3 | 139 |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty 2025 | not yet recruiting | Phase 2 | 80 |
| NCT03192657 | Basiliximab Treating Interstitial Pneumonia of CADM 2017 | status unknown | Phase 2 | 100 |
| NCT07377058 | RCT of Tocilizumab for Anti-MDA5+DM 2025 | recruiting | Not applicable | 110 |
Published literature
- Cochrane review Clinically Amyopathic Dermatomyositis: Epidemiology, Clinical Presentation, Pathophysiology, Treatment, and Prognosis: A Systematic ReviewGonçalves Júnior J, Dos Santos JIA, Shinjo SK · Rheumatology and therapy · 2026 · PMID 42301567
- Systematic review A Child with Refractory and Relapsing Anti-3-Hydroxy-3-Methylglutaryl-Coenzyme A Reductase Myopathy: Case-Based ReviewSener S, Batu ED, Sari S et al. · Journal of neuromuscular diseases · 2023 · PMID 36617789
- Cochrane review Recommendations for the treatment of anti-melanoma differentiation-associated gene 5-positive dermatomyositis-associated rapidly progressive interstitial lung diseaseRomero-Bueno F, Diaz Del Campo P, Trallero-Araguás E et al. · Seminars in arthritis and rheumatism · 2020 · PMID 32534273
- Meta-analysis Treatment of idiopathic inflammatory myositis associated interstitial lung disease: A systematic review and meta-analysisBarba T, Fort R, Cottin V et al. · Autoimmunity reviews · 2019 · PMID 30572131
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD80. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Cyclosporine approved for Inflammatory Myopathies (Dermatomyositis / PM / IBM)?
Cyclosporine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Myopathies (Dermatomyositis / PM / IBM) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Myopathies (Dermatomyositis / PM / IBM). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Cyclosporine in clinical trials for Inflammatory Myopathies (Dermatomyositis / PM / IBM)?
ClinicalTrials.gov lists 4 registered trials linking Cyclosporine to Inflammatory Myopathies (Dermatomyositis / PM / IBM): 1 is currently recruiting; 1 is active or not yet recruiting; 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00323960). It plans or enrolled 139 participants. Registration activity spans 2006 to 2025.
What does the evidence show for Cyclosporine in Inflammatory Myopathies (Dermatomyositis / PM / IBM)?
Cyclosporine has both completed registered trials and synthesis-level publications linked to Inflammatory Myopathies (Dermatomyositis / PM / IBM). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD80. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.