Gadoteric Acid
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Gadoteric Acid: From MRI Contrast Imaging to Osteoarthritis
One-Sentence Summary
Gadoteric acid is a macrocyclic gadolinium-based MRI contrast agent, used for diagnostic imaging rather than treatment. The TxGNN model predicts it may be effective for osteoarthritis, but no clinical trials and no publications currently support this direction. The prediction rests on model output alone and has no mechanistic or clinical backing.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | No approved indication text in the registration data (the agent is a diagnostic MRI contrast agent) |
| Predicted New Indication | Osteoarthritis |
| TxGNN Prediction Score | 98.57% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 4 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Gadoteric acid is a paramagnetic gadolinium chelate used to enhance contrast in MRI. It has no known therapeutic pharmacology, is not metabolised, and is excreted unchanged by the kidney.
The high TxGNN score most likely reflects network proximity or imaging associations with joint disease in the knowledge graph, not a therapeutic mechanism. No anti-inflammatory, chondroprotective or disease-modifying activity is documented. Gadolinium retention and the risk of nephrogenic systemic fibrosis argue against any therapeutic use.
The other top predictions show the same pattern:
| Rank | Predicted Disease | Score | Assessment |
|---|---|---|---|
| 2 | Osteoarthritis susceptibility | 98.39% | Genetic susceptibility phenotype, not a treatable indication; graph artefact |
| 3 | Rheumatoid arthritis | 98.21% | No immunomodulatory mechanism; link limited to diagnostic imaging of synovitis |
| 4 | Pseudoachondroplasia | 97.80% | Rare skeletal dysplasia (COMP mutations); no action on this pathway |
| 5 | Hepatic porphyria | 97.72% | No link to heme biosynthesis |
| 6 | Gout | 97.66% | No known effect on urate metabolism or crystal-induced inflammation |
| 7 | Brachyolmia | 97.63% | Genetic skeletal dysplasia; no plausible mechanism |
| 8 | Acromesomelic dysplasia, Hunter-Thompson type | 97.49% | GDF5 signalling defect; no known interaction |
| 9 | Myosclerosis | 97.38% | No rationale; gadolinium agents are linked to fibrosing disorders in renal impairment, a safety concern |
| 10 | Brachyolmia-amelogenesis imperfecta syndrome | 97.38% | LTBP3-related genetic syndrome; no pharmacological link |
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 |
|---|---|---|---|
| SIN15973P | DOTAGRAF Solution for Injection 0.5 mmol/mL | Injection, solution | Not stated in the data |
| SIN09008P | DOTAREM Injection 27.932 g/100 mL | Injection | Not stated in the data |
| SIN15693P | CLARISCAN Solution for Injection in Vial 0.5 mmol/mL | Injection, solution | Not stated in the data |
| SIN15694P | CLARISCAN Solution for Injection in Pre-filled Syringe 0.5 mmol/mL | Injection, solution | Not stated in the data |
All four licences are valid single-ingredient injectable products.
Safety Considerations
- Drug Interactions: 30 interactions were identified, and all 20 listed in the data are rated Moderate. They are mainly with:
- Beta-blockers: acebutolol, atenolol, betaxolol (including ophthalmic), bisoprolol, carvedilol, nadolol, labetalol, metoprolol, and the ophthalmic agents carteolol, levobunolol, metipranolol and timolol.
- Calcium channel blockers: nifedipine, amlodipine, levamlodipine, diltiazem, verapamil, clevidipine and isradipine.
- Class concerns: Gadolinium-based agents carry a risk of nephrogenic systemic fibrosis in patients with renal impairment, and gadolinium retention has been reported. These points come from the mechanistic assessment, not from label text.
Please refer to the package insert for the full warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by the model score. There are no clinical trials or publications, and no therapeutic mechanism is plausible for a diagnostic contrast agent. Its known safety profile also argues against therapeutic use.
To proceed, the following is needed:
- Package insert warnings and contraindications from HSA, so safety screening can begin
- Mechanism of action data, to allow any mechanistic-link analysis
- Preclinical or clinical evidence of a therapeutic effect in osteoarthritis
- A route and dosing feasibility assessment (route compatibility has not yet been evaluated)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.