Erythromycin
| Evidence Level: L4 | Predicted Indications: 5 |
Table of Contents
Erythromycin: From Antibacterial Use to Punctate Epithelial Keratoconjunctivitis
One-Sentence Summary
Erythromycin is a macrolide antibacterial, and the Evidence Pack does not list its approved indications. The TxGNN model predicts it may be effective for punctate epithelial keratoconjunctivitis, but there are currently 0 clinical trials and only 2 publications, both indirect, supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not listed in the Evidence Pack (approved indication text is empty for all licenses) |
| Predicted New Indication | Punctate epithelial keratoconjunctivitis |
| TxGNN Prediction Score | 99.89% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 (total licenses, including NDAs and ANDAs) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, erythromycin is an antibacterial macrolide. Macrolides are used in chronic blepharokeratoconjunctivitis for their antibacterial and anti-inflammatory effects, so a mechanistic link to punctate epithelial keratoconjunctivitis is plausible.
The supporting evidence is weak. One paper covers management of pediatric blepharokeratoconjunctivitis, a related but different condition. The other is a microsporidia keratoconjunctivitis case report that has no relevance to erythromycin. The high TxGNN score (0.999) is a model prediction only and is not backed by erythromycin-specific studies in this disease.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 11495307 | 2001 | Review | J Pediatr Ophthalmol Strabismus | Describes the history, symptoms, signs and treatment of chronic blepharokeratoconjunctivitis in children. Indirect: it does not evaluate erythromycin specifically. |
| 32826651 | 2021 | Case report | Cornea | Microsporidia (Encephalitozoon hellem) keratoconjunctivitis in an immunocompetent adult, diagnosed by metagenomic sequencing. Not relevant to erythromycin. |
US Market Information
The Evidence Pack lists 20 licenses in total; the main 5 are shown below. Approved indication text was not provided for these products. Other listed dosage forms include topical gel, ointment, oral tablets, suspension and lyophilized injection.
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| ANDA064126 | Ery | Swab |
| ANDA212015 | Erythromycin | Coated tablet |
| NDA050207 | E.E.S | Granule for suspension |
| ANDA061621 | Erythromycin | Film-coated tablet |
| ANDA216212 | Erythromycin ethylsuccinate | For suspension |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: This prediction rests almost entirely on the model score. There are no clinical trials, and the two publications are indirect or irrelevant. Package insert safety data are also missing, which blocks progression to safety screening.
To proceed, the following is needed:
- Package insert warnings and contraindications, obtained from the FDA label
- Mechanism of action data (for example, from DrugBank)
- Erythromycin-specific studies in punctate epithelial keratoconjunctivitis or closely related ocular surface disease
- Confirmation of an ophthalmic-suitable route, since the Evidence Pack has not assessed route compatibility for this indication
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.