Tildrakizumab
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Tildrakizumab
- Tildrakizumab: From an Anti-IL-23 Biologic (Approved Indication Not Listed) to Severe Nonproliferative Diabetic Retinopathy
Tildrakizumab: From an Anti-IL-23 Biologic (Approved Indication Not Listed) to Severe Nonproliferative Diabetic Retinopathy
One-Sentence Summary
Tildrakizumab is an anti-IL-23 p19 monoclonal antibody that is registered and marketed in Singapore as ILUMYA, but the registration record compiled for this report does not list an approved indication. The TxGNN model predicts it may be effective for severe nonproliferative diabetic retinopathy. Currently there are 0 clinical trials and 0 publications supporting this prediction, so it rests on the computational score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not listed in the Singapore registration data |
| Predicted New Indication | Severe nonproliferative diabetic retinopathy |
| TxGNN Prediction Score | 99.63% |
| 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 in the compiled data. Based on its drug class, tildrakizumab is an anti-IL-23 p19 monoclonal antibody. It blocks the IL-23/IL-17 inflammatory axis.
Chronic low-grade inflammation contributes to diabetic retinopathy, and IL-23/Th17 signalling is a hypothetical contributor. The link is speculative. There is no direct or indirect clinical evidence for tildrakizumab in this setting. Standard therapies (anti-VEGF, laser, corticosteroids) act on different pathways.
The high TxGNN score (99.63%, rank 5263) is a computational prediction only. It should not be read as evidence of efficacy.
Other Predicted Indications
The other top-ranked predictions also have no clinical trials or literature, and all are at evidence level L5 with a Hold recommendation.
| Rank | Predicted Indication | TxGNN Score | Mechanistic Plausibility |
|---|---|---|---|
| 2 | Diabetic retinopathy | 99.53% | Hypothetical; inflammation and IL-23/Th17 signalling |
| 3 | Diabetic cataract | 99.21% | Low; likely a knowledge-graph artefact |
| 4 | Drug-induced osteoporosis | 99.20% | Tenuous; IL-23/IL-17 influences bone remodelling in inflammatory arthritis |
| 5 | Cortical cataract | 98.91% | Low |
| 6 | Nuclear senile cataract | 98.91% | Low |
| 7 | Senile cataract | 98.89% | Low |
| 8 | Mature cataract | 98.86% | Very low; managed surgically |
| 9 | Immature cataract | 98.86% | Low |
| 10 | Type 2 diabetes-associated cataract | 98.86% | Low |
The cataract predictions share near-identical scores. This suggests a graph-proximity artefact rather than a disease-specific signal.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN17076P | ILUMYA Solution for Injection in Pre-filled Syringe 100 mg/mL | Injection, solution | Not listed in the registration data |
The manufacturer is Vetter Pharma-Fertigung GmbH & Co. KG. The product is an injectable only, and the licence is valid.
Safety Considerations
- Drug Interactions: 78 interactions were identified. The 20 listed below are the ones retrieved in detail.
- Major: adalimumab, baricitinib, certolizumab pegol, cladribine. These are mostly immunosuppressive combinations with additive immunosuppression and infection risk.
- Moderate: roflumilast, tacrolimus, azathioprine, cyclosporine, alefacept, alemtuzumab, anakinra, canakinumab, denosumab, tetanus toxoid vaccine, anthrax vaccine, and live oral cholera vaccine. Live-vaccine combinations need particular attention.
- Minor: zinc sulfate, zinc acetate, zinc gluconate, zinc chloride.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a model score. There are no clinical trials or publications, and the mechanistic link to diabetic retinopathy is speculative. The approved indication and mechanism data are also missing from the compiled data.
To proceed, the following is needed:
- The package insert from the Singapore Health Sciences Authority (HSA), covering the approved indication, warnings, and contraindications. This is a blocking gap for safety screening.
- Mechanism of action data from DrugBank.
- Preclinical or mechanistic evidence for IL-23/Th17 involvement in diabetic retinopathy, such as vitreous or retinal cytokine studies and animal models.
- A literature and trial registry search for IL-23 inhibition in retinal disease.
- An assessment of route compatibility. The current product is a subcutaneous injection, while retinal disease might require intravitreal delivery.
- A review of the interaction profile with immunosuppressants and live vaccines in diabetic patients.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.