Clarithromycin
| Evidence Level: L5 | Predicted Indications: 5 |
Table of Contents
Clarithromycin: From Macrolide Antibacterial to Polyclonal Hyperviscosity Syndrome
One-Sentence Summary
Clarithromycin is a macrolide antibiotic marketed in the US as generic tablets and suspension. The TxGNN model predicts it may be effective for polyclonal hyperviscosity syndrome, but this rests on a graph-based score alone, with 0 clinical trials and 0 publications supporting it.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Polyclonal hyperviscosity syndrome |
| TxGNN Prediction Score | 99.35% |
| Evidence Level | L5 (model prediction only) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 (all listed products are ANDA generics) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Clarithromycin is a macrolide antibacterial, and its efficacy against bacterial infections is well established.
Polyclonal hyperviscosity syndrome involves raised blood viscosity from excess polyclonal immunoglobulins. No plausible mechanistic link to an antibacterial macrolide has been identified. The high score (99.35%) reflects graph proximity in the TxGNN knowledge graph only, and it is not evidence of efficacy. No trials or literature were found to support it.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA065489 | Clarithromycin | Film-coated tablet | A-S Medication Solutions |
| ANDA203584 | Clarithromycin | Film-coated tablet | Lannett Company, Inc. |
| ANDA210459 | Clarithromycin | Film-coated tablet | Alembic Pharmaceuticals Limited |
| ANDA203584 | Clarithromycin | Film-coated tablet | Proficient Rx LP |
| ANDA065489 | Clarithromycin | Film-coated tablet | Proficient Rx LP |
Approved indication text was not provided for these listings. Other dosage forms on the market include plain tablets, extended-release film-coated tablets, and powder for oral suspension.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no clinical trials, no literature, and no plausible mechanistic link. It is a graph-based score only (Evidence Level L5).
Among the other predictions for this drug, punctate epithelial keratoconjunctivitis (rank 4) has the most biologically plausible rationale. Macrolides have anti-inflammatory effects in meibomian gland-related ocular surface disease, and a 2024 observational study (PMID 38472959) is a possible lead. It is currently classed as a research question, pending full-text review.
To proceed, the following is needed:
- Mechanism of action data for clarithromycin
- Package insert warnings and contraindications, needed before any safety screening
- A literature and mechanistic review to establish whether any biological link to polyclonal hyperviscosity syndrome exists
- Consideration of prioritizing better-supported candidates, such as punctate epithelial keratoconjunctivitis, over this prediction
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.