Nandrolone Decanoate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Nandrolone Decanoate
- Nandrolone Decanoate: From an Unspecified Original Indication to Brain Small Vessel Disease (COL4A1-related)
Nandrolone Decanoate: From an Unspecified Original Indication to Brain Small Vessel Disease (COL4A1-related)
One-Sentence Summary
Nandrolone decanoate is an injectable anabolic androgen steroid marketed in Singapore, but the approved indication text is not recorded in the data compiled for this report. The TxGNN model predicts it may be effective for brain small vessel disease 1 with or without ocular anomalies, but there are 0 clinical trials and 0 publications supporting this top prediction. The overall evidence is very weak, and the only related literature concerns other predicted diseases (diabetic nephropathy and type 1 diabetes).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (the approved indication text on the Singapore licence is empty) |
| Predicted New Indication | Brain small vessel disease 1 with or without ocular anomalies |
| TxGNN Prediction Score | 88.55% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Nandrolone decanoate is a long-acting ester of nandrolone, an anabolic steroid that acts as an androgen receptor agonist. Its original approved indication is not recorded in the compiled data.
For the top prediction, no mechanistic link is established. Brain small vessel disease 1 is a monogenic disorder caused by COL4A1 mutations that affect basement membrane integrity. Nandrolone has no known action on collagen IV biology. The high TxGNN score (88.55%) is a graph-based computational prediction only.
The same is true of the second-ranked prediction, autosomal dominant familial hematuria-retinal arteriolar tortuosity-contractures syndrome (score 88.35%), another COL4A1-related basement membrane disorder. A few lower-ranked predictions have a weak or speculative rationale, noted below.
Other Predicted Indications (for reference)
| Rank | Predicted Disease | Score | Evidence Level | Comment |
|---|---|---|---|---|
| 3 | Autoimmune oophoritis | 87.16% | L5 | Speculative link via sex-steroid modulation of the immune and gonadal axis. Effect is unclear and could be harmful. |
| 4 | Diabetic nephropathy | 86.90% | L4 | Indirect link (anabolic effect on catabolism and renal anaemia). Only one 1970 case-level report. |
| 5 | Type 1 diabetes mellitus | 85.52% | L4 | Only a 1986 rat study, with inconsistent results across experiments. |
| 6 | Cholecystolithiasis | 83.62% | L5 | Anabolic androgens are associated with cholestasis, which may worsen rather than help. |
| 7 | Hyperuricemia (obsolete term) | 83.08% | L5 | Androgens are generally associated with higher uric acid, so benefit is implausible. |
| 8 | Resistance to thyroid hormone (THRB) | 81.90% | L5 | No known cross-regulation to correct THRB dysfunction. |
| 9 | Scalp dermatosis | 81.31% | L5 | Androgens can aggravate some scalp conditions. |
| 10 | Hyperthyroidism | 79.63% | L5 | Androgens alter thyroid hormone measurements but do not treat the disease. |
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for the top-ranked prediction. For other predicted indications, the following were found:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 5430111 | 1970 | Case series / clinical observation | Ophthalmologica | Reported favourable effects of nandrolone decanoate on the eye and kidney in a few cases of Kimmelstiel-Wilson syndrome (diabetic nephropathy). Old and uncontrolled. |
| 3708906 | 1986 | Preclinical animal study | Clin Exp Immunol | In BB rats, nandrolone decanoate significantly lowered diabetes incidence in males in one experiment but not in a second. Sex, gonadectomy and other steroids had no effect. |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN04300P | DECA-DURABOLIN INJECTION 25 mg/ml | Injection | Not recorded |
Cytotoxicity
Not applicable. Nandrolone decanoate is not an antineoplastic drug, so this section is omitted from the assessment.
Safety Considerations
Please refer to the package insert for safety information.
No drug-drug interaction records were found in the data compiled for this report. Based on general knowledge of androgens (not on the compiled data), fluid retention, cardiovascular effects and cholestasis are relevant concerns for some of the predicted populations.
Conclusion and Next Steps
Decision: Hold
Rationale: All predictions are model-based, and the top two are for rare COL4A1-related disorders with no plausible mechanistic link and no trials or literature. The only supporting studies (a 1970 case series and a 1986 rat study) are weak and relate to other diseases. Safety data and the original indication are also missing.
To proceed, the following is needed:
- The package insert from HSA (warnings, contraindications, approved indication), which is currently a blocking gap
- Mechanism of action data (for example from DrugBank)
- Preclinical evidence on whether androgen receptor agonism can affect COL4A1-related basement membrane pathology
- A reassessment of lower-ranked predictions with some indirect rationale (diabetic nephropathy, type 1 diabetes) using modern controlled data
- Confirmation of route and formulation compatibility for any proposed new indication
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.