Ofloxacin
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Ofloxacin: From Bacterial Infections to Hyperamylasemia
One-Sentence Summary
Ofloxacin is a fluoroquinolone antibiotic, originally used to treat bacterial infections such as typhoid fever, urinary tract infection, bronchitis, and bacterial pneumonia. The TxGNN model gives its top prediction, hyperamylasemia, a very high score, but there are 0 clinical trials and 0 publications supporting it. The prediction rests on the model alone. The only predicted indication with meaningful supporting data is septicemic plague (preclinical studies only).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Bacterial infections (typhoid fever, salmonellosis, urinary tract infection, bronchitis, bacterial pneumonia, and others) |
| Predicted New Indication | Hyperamylasemia (top-ranked prediction) |
| TxGNN Prediction Score | 99.91% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (no currently valid licenses) |
| Number of NDAs | 12 (all cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Ofloxacin is a fluoroquinolone antibacterial, and this class is generally known to inhibit bacterial DNA gyrase and topoisomerase IV. Its efficacy in bacterial infections is established.
For hyperamylasemia, no plausible mechanistic link was identified. An antibacterial mechanism has no obvious bearing on elevated serum amylase. The high score (99.91%) is a graph-based prediction only. Other top-ranked predictions (polyclonal hyperviscosity syndrome, congenital analbuminemia, blood group incompatibility, premalignant and congenital hematological conditions) show the same pattern: high scores, no trials, and no mechanistic rationale.
Among the ten predictions, the most biologically coherent is septicemic plague (rank 8). Ofloxacin is active in vitro against Yersinia pestis and has shown efficacy in mouse models of experimental plague. This extends its existing antibacterial use to a related pathogen rather than introducing a new mechanism. The evidence is preclinical, with no human trials.
Clinical Trial Evidence
Currently no related clinical trials registered for hyperamylasemia or for any of the other nine predicted indications.
Literature Evidence
No literature was found for hyperamylasemia, the top-ranked prediction.
For reference, the best-supported prediction is septicemic plague. All of these studies are preclinical:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 8540736 | 1995 | In vitro | Antimicrob Agents Chemother | Among 78 Y. pestis strains, ofloxacin was among the most active agents, behind ceftriaxone and ciprofloxacin |
| 8913481 | 1996 | In vitro | Antimicrob Agents Chemother | Ofloxacin and levofloxacin were highly active against 100 human Y. pestis isolates (MIC90 < 0.03 µg/mL) |
| 8203841 | 1994 | Animal | Antimicrob Agents Chemother | Ofloxacin was active in a mouse model of systemic Y. pestis infection, compared with beta-lactams, aminoglycosides, and doxycycline |
| 9517950 | 1998 | Animal | Antimicrob Agents Chemother | Mouse model of pneumonic plague used to compare antibiotic treatments |
| 16127904 | 2002 | Animal | Antibiot Khimioter | Ofloxacin was effective for prophylaxis and treatment of experimental plague, with lower efficacy against strains lacking fraction I and mouse toxin |
| 10987101 | 2000 | Animal | Antibiot Khimioter | Fluoroquinolones, including ofloxacin, interfered with vaccine-induced immunity in mice, which supports combining emergency and specific prevention |
| 11871319 | 2001 | Animal | Antibiot Khimioter | Primate model of bubonic plague developed to evaluate antibacterial efficacy |
Several other retrieved papers concern resistance mechanisms or other organisms and are only tangentially relevant.
US Market Information
All 12 US licenses are cancelled. No approved-indication text is available. The first five are listed below.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA076622 | Ofloxacin | Solution/drops | A-S Medication Solutions |
| ANDA217904 | Ofloxacin | Solution | Leading Pharma, LLC |
| ANDA091656 | Ofloxacin | Coated tablet | Nivagen Pharmaceuticals, Inc. |
| ANDA076527 | Ofloxacin Otic | Solution | Bryant Ranch Prepack |
| ANDA211525 | Ofloxacin | Solution | A-S Medication Solutions |
Safety Considerations
No label warnings or contraindications were available in the data compiled for this report. Please refer to the package insert for authoritative safety information.
- Contraindication signals from the knowledge graph (not label text): These include long QT syndrome, torsades de pointes, liver failure and liver disease, epilepsy, kidney disease and impaired renal function, myasthenia gravis, tendinitis, peripheral neuropathy, diabetes mellitus and diabetic ketoacidosis, rhabdomyolysis, thrombocytopenia, leukopenia, anemia, Clostridium difficile colitis, and drug-induced liver injury.
- Drug interactions: The interaction search returned 100 entries. Major interactions in the displayed sample include corticosteroids (hydrocortisone, dexamethasone, betamethasone, triamcinolone), bupropion, and chlorpropamide. Moderate interactions include antidiabetic agents (metformin, pioglitazone, acarbose, alogliptin, canagliflozin, albiglutide), famotidine, loperamide, aspirin, and calcium and potassium salts.
The knowledge-graph contraindication of peripheral neuropathy argues against the prediction for hematological disease associated with acquired peripheral neuropathy.
Conclusion and Next Steps
Decision: Hold
Rationale: The top prediction, hyperamylasemia, has no clinical trials, no literature, and no plausible mechanistic link. All US licenses are cancelled, and the label safety data are missing. Of the ten predictions, only septicemic plague has biologically coherent preclinical support (L4), and that remains a research question rather than a development-ready indication.
To proceed, the following is needed:
- FDA package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data from DrugBank
- For hyperamylasemia, a mechanistic hypothesis and any clinical or observational data. Without them, the prediction should not advance.
- For septicemic plague, a review of current guideline-recommended therapies and of any human data
- Clarification of current US regulatory and market status, since all licenses are cancelled
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.