Enrofloxacin
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Enrofloxacin: From Veterinary Bacterial Infections to Heart Disease
⚠️ Important Notice: This report is for research reference only and does not constitute medical advice. All drug repurposing candidates require clinical validation before application.
One-Sentence Summary
Enrofloxacin is a fluoroquinolone antibiotic used exclusively in veterinary medicine to treat bacterial infections in animals — it has never been approved for human use. The TxGNN model predicts it may have relevance for heart disease, with 0 clinical trials and 20 publications retrieved; however, all publications are veterinary studies with no direct mechanistic link to human cardiac disease. The overall evidence for this prediction is extremely weak, and this candidate is not considered suitable for further human drug repurposing development at this time.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Veterinary use only — bacterial infections in animals (not approved for human use) |
| Predicted New Indication | Heart Disease |
| TxGNN Prediction Score | 99.94% |
| Evidence Level | L5 |
| Denmark Market Status | Not marketed |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Enrofloxacin is a second-generation fluoroquinolone antibiotic that belongs to the same pharmacological class as ciprofloxacin. It acts by inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for bacterial DNA replication and repair. Critically, enrofloxacin is a veterinary-only antibiotic; it is not licensed for human use in any jurisdiction.
The mechanistic link between enrofloxacin and heart disease is extremely weak. Its antibacterial mechanism of action has no direct relevance to the primary pathological processes underlying human heart disease — including cardiomyopathy, coronary artery disease, or heart failure. The only indirect hypothesis would be that, where heart disease is triggered or complicated by bacterial infection (e.g., bacterial myocarditis or infective endocarditis), an antibiotic might play a supportive role. However, this is a generic antibacterial concept and not specific to enrofloxacin.
Furthermore, fluoroquinolones as a class carry an FDA black box warning for risk of aortic aneurysm and aortic dissection, raising specific safety concerns in the context of cardiovascular disease. The retrieved literature consists entirely of veterinary and aquaculture studies, with no human mechanistic or clinical data. The high TxGNN prediction score most likely reflects spurious graph-embedding propagation through shared disease nodes (e.g., cardiac manifestations of bacterial infections in animals) rather than a true pharmacological signal for human repurposing.
Clinical Trial Evidence
Currently no related clinical trials registered for enrofloxacin and heart disease.
Literature Evidence
All retrieved publications are veterinary or preclinical animal studies. None provide direct evidence for human cardiac benefit. The ten most relevant are listed below for completeness.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 41190687 | 2025 | Case Report (Veterinary) | J Am Anim Hosp Assoc | Dog with Brucella canis myocarditis and pericarditis treated with ampicillin/sulbactam + enrofloxacin; cardiac troponin-I markedly elevated |
| 34157764 | 2021 | Case Report (Veterinary) | Tierarztliche Praxis | Cat with left-sided congestive heart failure and suspected myocarditis following FLUTD treatment (enrofloxacin in treatment context) |
| 36342628 | 2023 | Case Series (Veterinary) | Vet Res Commun | Histophilus somni-induced subacute cardiac death in feedlot cattle; antimicrobial susceptibility including enrofloxacin assessed |
| 33076564 | 2020 | Review (Veterinary) | Pathogens | Renibacterium salmoninarum causes bacterial kidney disease in salmonids with cardiac involvement; enrofloxacin among treatments discussed |
| 23562103 | 2013 | PK Study (Amphibian) | J AALAS | Enrofloxacin tissue distribution in Xenopus laevis including heart tissue; rapid absorption and broad tissue diffusion confirmed |
| 17269886 | 2007 | Animal Toxicity Study | Am J Vet Res | High-dose oral enrofloxacin in cats caused systemic toxicity; study characterised ocular and systemic adverse effects |
| 31226987 | 2019 | Toxicology Review (Veterinary) | BMC Vet Res | Fluoroquinolone reproductive and developmental toxicity in birds; adverse effects including cardiovascular manifestations during egg incubation |
| 17187945 | 2007 | Veterinary Efficacy Study | Vet Microbiol | Enrofloxacin (3 and 5 days) vs amoxicillin/florfenicol for respiratory disease in turkeys with dual bacterial infection following APV priming |
| 36866813 | 2023 | Case Series (Veterinary) | J Fish Diseases | Streptococcus iniae + Aeromonas veronii co-infection in Giant snakehead with haemorrhagic signs; enrofloxacin susceptibility tested |
| 40827537 | 2026 | Case Series (Veterinary) | J Fish Diseases | First report of Nocardia seriolae in channel catfish with liver and heart granulomas; antibiotic sensitivity including fluoroquinolones assessed |
Denmark Market Information
Enrofloxacin holds no marketing authorisations in Denmark. It is not registered by the Danish Medicines Agency (Lægemiddelstyrelsen) for human use, nor does it hold a centralised EMA authorisation for human medicine. Enrofloxacin is authorised in Denmark exclusively as a veterinary medicinal product under separate veterinary licensing regulation.
Safety Considerations
Detailed human safety data (warnings, contraindications, drug interactions) is not available for enrofloxacin, as it is not approved for human use and no human Summary of Product Characteristics (SmPC) exists.
Based on class-level fluoroquinolone pharmacology, the following safety signals are known:
- Cardiovascular risk: Fluoroquinolones carry an FDA black box warning for increased risk of aortic aneurysm and aortic dissection, which is particularly relevant in the context of any proposed cardiac indication.
- Musculoskeletal toxicity: Fluoroquinolones are associated with tendinopathy, tendon rupture, and chondrotoxicity (cartilage damage), with established contraindications in children and growing animals.
- QT prolongation: Class effect risk of cardiac arrhythmia through QT interval prolongation.
- CNS effects: Potential for seizures and neuropsychiatric reactions (class effect).
Please refer to the veterinary Summary of Product Characteristics and current fluoroquinolone class safety data for further information.
Conclusion and Next Steps
Decision: Hold
Rationale: Enrofloxacin is a veterinary-only antibiotic with no human marketing authorisation in Denmark or any other jurisdiction. Its mechanism of action — bacterial DNA gyrase inhibition — has no plausible direct therapeutic link to human heart disease. All retrieved literature consists exclusively of veterinary studies, and no human clinical trials exist. Additionally, fluoroquinolones carry a cardiovascular safety liability (aortic aneurysm/dissection black box warning) that makes cardiac repurposing particularly contraindicated. The high TxGNN score (99.94%) is assessed as a probable false positive arising from graph-embedding propagation through shared bacterial-cardiac disease nodes in the knowledge graph.
To proceed, the following would be required — though the current benefit-risk profile does not support further development:
- Demonstration of a plausible human-specific mechanism of action linking enrofloxacin to cardiac pathophysiology (beyond non-specific antibacterial activity)
- Human safety data and assessment of cardiovascular risk (particularly aortic dissection risk)
- At minimum one human observational study or case series before any prospective trial design
- Regulatory clarity on the use of a veterinary-only compound in human subjects (requires specific veterinary-to-human bridging justification)
- Ethics review given the known cardiovascular safety signals for the fluoroquinolone class
This report is generated for research purposes only and does not constitute medical advice. Drug repurposing candidates require rigorous clinical validation before any clinical application. Data cut-off: 5 April 2026.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.