Atazanavir
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
Atazanavir: From HIV-1 Infection to Feline Acquired Immunodeficiency Syndrome
One-Sentence Summary
Atazanavir is an HIV-1 protease inhibitor used in antiretroviral therapy. The TxGNN model predicts it may be effective for feline acquired immunodeficiency syndrome (FIV), a veterinary condition, but currently there are 0 clinical trials and 0 publications supporting this specific prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | HIV-1 infection (inferred from the drug class; the license records contain no indication text) |
| Predicted New Indication | Feline acquired immunodeficiency syndrome |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 17 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, atazanavir is an HIV-1 protease inhibitor. It blocks the maturation of infectious virions, and its efficacy in HIV-1 treatment is well established.
FIV is a lentivirus related to HIV, so protease inhibition is mechanistically plausible. However, FIV protease differs structurally from HIV-1 protease, so cross-species activity is unverified. The prediction is model-only, with no trial or literature support in the dataset.
FIV is an animal disease with no human clinical relevance. The high score is best read as a knowledge-graph relationship (a related virus and a shared drug target class), not as a signal for human repurposing.
Two other predictions in the same list carry real evidence: “AIDS related complex” (rank 5) and “congenital human immunodeficiency virus” (rank 6). Both are HIV-1 conditions, so they are essentially on-label use or close extensions rather than true repurposing.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
The record lists 17 authorizations in total. The main distinct authorizations are below. Approved indication text is blank in the source records.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| NDA021567 | REYATAZ | Capsule, gelatin coated | E.R. Squibb & Sons, L.L.C. |
| ANDA212278 | Atazanavir | Capsule | Camber Pharmaceuticals, Inc. |
| ANDA204806 | Atazanavir Sulfate | Capsule | Aurobindo Pharma Limited |
Available dosage forms across products include oral capsules, tablets and a powder.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on model output (L5). It has no trials or literature, and the target condition is a veterinary disease with no human clinical relevance. The mechanistic link is plausible but unverified.
To proceed, the following is needed:
- Mechanism of action data (MOA) from DrugBank
- FDA package insert warnings and contraindications, which are currently missing
- Any in vitro or animal evidence of atazanavir activity against FIV protease. Without it, no veterinary development case exists.
- For human-relevant work, shift focus to ranks 5 and 6. Completed Phase 3 trials support these, but they should be treated as on-label HIV-1 use. For congenital HIV, the perinatal population and neonatal hyperbilirubinemia risk need to be checked against the full trial records.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.