Ozenoxacin
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Ozenoxacin: From Acne to Malaria
One-Sentence Summary
Ozenoxacin is a topical non-fluorinated quinolone antibacterial, originally used to treat acne. The TxGNN model predicts it may be effective for malaria, but this is a model prediction only, with 0 clinical trials and 0 publications supporting it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Acne |
| Predicted New Indication | Malaria |
| TxGNN Prediction Score | 0.9916 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, ozenoxacin is a topical quinolone that inhibits bacterial DNA gyrase and topoisomerase IV. Its efficacy in acne is attributed to this antibacterial activity.
The plausible link to malaria is theoretical. The Plasmodium apicoplast contains a gyrase-like target, which gives a conceptual basis for quinolone activity against the parasite. However, ozenoxacin is formulated only for topical use, with minimal systemic exposure. Malaria is a bloodborne infection, so a cream is unlikely to reach therapeutic concentrations at the site of disease.
The high TxGNN score (0.9916) comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence, and it is not clinical or experimental support.
India Market Information
All 20 registrations are valid single-ingredient topical creams. The approved indication text is not available. The main authorizations are listed below.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 199925 | S-Clear Cream | Cream, tube of 10 gm | Alkem Laboratories Ltd |
| 26555 | B-Oze Cream | Cream, tube of 10 gm | Oaknet Healthcare Pvt Ltd |
| 162775 | Ozx Cream | Cream, tube of 5 gm | Glowderma Labs Pvt Ltd |
| 162701 | Ozebrut Cream | Cream, tube of 5 gm | Mankind Pharma Ltd |
| 150370 | Noxa Cream | Cream, tube of 5 gm | Indoco Remedies Ltd |
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on model score alone (Evidence Level L5), with no clinical trials or literature. The topical-only formulation is also poorly suited to a systemic bloodborne infection such as malaria.
To proceed, the following is needed:
- Package insert warnings and contraindications, which are currently missing and block safety screening
- Detailed mechanism of action data
- In vitro data on ozenoxacin activity against Plasmodium
- Evidence that adequate systemic exposure is achievable, or a different formulation, since only topical creams are currently marketed
- Reassessment of more plausible topical indications, such as demodicidosis of the sebaceous gland, if further evidence emerges
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.