Ciprofloxacin
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Ciprofloxacin: From Bacterial Infections to Diffuse Scleroderma
One-Sentence Summary
Ciprofloxacin is a fluoroquinolone antibiotic that is marketed in the US under 20 licenses. The TxGNN model predicts it may be useful for diffuse scleroderma. The evidence is thin: no registered clinical trials and 2 publications, one of which reports a small controlled trial whose design and results have not been confirmed.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Diffuse scleroderma |
| TxGNN Prediction Score | 99.87% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of Licenses | 20 (ANDA) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Ciprofloxacin is a fluoroquinolone that kills bacteria by inhibiting DNA gyrase and topoisomerase IV. That mechanism explains its antibacterial use but does not by itself explain an effect on scleroderma.
Two indirect links to scleroderma appear in the literature:
- Antifibrotic effect: A 2010 study (PMID 20507401) reports that oral ciprofloxacin may reduce skin fibrosis in scleroderma patients. Scleroderma is characterized by excessive skin fibrosis and microvascular injury.
- Gut bacterial overgrowth: Systemic sclerosis patients often have small bowel bacterial overgrowth (SIBO) with diarrhoea and weight loss. An antibiotic could help this complication (PMID 7728404). This would treat a complication, not the underlying disease.
Both links are plausible but indirect. The study designs were judged from titles and abstracts only and need full-text review.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 20507401 | 2010 | Clinical/translational study (design unconfirmed) | J Dermatol | Controlled, double-blind randomized trial testing whether oral ciprofloxacin reduces scleroderma severity, with skin fibrosis as the focus. The retrieved abstract is truncated and gives no results. |
| 7728404 | 1995 | Diagnostic cohort | Br J Rheumatol | 24 systemic sclerosis patients with malabsorption symptoms were tested for small bowel bacterial overgrowth, and treatment outcome was reported. It addresses gut overgrowth, not ciprofloxacin efficacy on scleroderma itself. |
US Market Information
The retrieved licenses have no approved indication text. Five of the 20 licenses are listed below.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA077859 | Ciprofloxacin | Tablet, film coated | Medsource Pharmaceuticals |
| ANDA076639 | Ciprofloxacin | Tablet | Coupler LLC |
| ANDA076593 | Ciprofloxacin Hydrochloride | Tablet, film coated | Westminster Pharmaceuticals, LLC |
| ANDA076558 | Ciprofloxacin | Tablet, film coated | Bryant Ranch Prepack |
| ANDA208921 | Ciprofloxacin | Tablet | Bryant Ranch Prepack |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a high model score, but the supporting evidence is limited. There are no registered trials, and the two publications are one small study of unconfirmed design and one gut-overgrowth cohort. This is a research question, not a development candidate.
To proceed, the following is needed:
- Full-text review of PMID 20507401 to confirm design, sample size, endpoints and results
- Package insert warnings and contraindications, which are needed before any safety screening
- Detailed mechanism of action data linking ciprofloxacin to fibrosis in scleroderma
- Any registered or planned trial in scleroderma, since none exists today
Other candidates: Among the other predicted indications, septicemic plague (rank 10) has much stronger support. It has a completed Phase 2 randomized non-inferiority trial (NCT01243437, n=200) and a 2025 randomized trial in bubonic plague (PMID 40768716), and it is rated L2 (Proceed with Guardrails). That may be a labeling gap rather than true repurposing, and it should be evaluated separately.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.