Norgestimate
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Norgestimate: Zinc, elevated plasma
One-Sentence Summary
Norgestimate is a progestin used in combined oral contraceptives. The data compiled for this report link it to acne, postmenopausal osteoporosis, osteoporosis and atrophic vaginal conditions. The TxGNN model predicts it may be relevant to elevated plasma zinc, but no clinical trials and no publications currently support this direction. The prediction is model-derived only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Zinc, elevated plasma |
| TxGNN Prediction Score | 0.9906 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 6 of 6) |
| Number of DINs | 6 (marketed: 6) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available for this drug. Norgestimate is generally known as a progestin (a prodrug of levonorgestrel and norelgestromin) used in combined oral contraceptives. Its listed indications are hormonal in nature.
No established mechanistic link to elevated plasma zinc could be identified from the data compiled for this report. Hormonal contraceptives have been discussed in the wider literature as altering circulating zinc and copper levels, but nothing in the compiled data supports this.
The TxGNN score of 0.9906 comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence. It should not be read as clinical evidence. In addition, “elevated plasma zinc” is a laboratory finding rather than a disease with a clear therapeutic goal. It is unclear whether lowering zinc would be a meaningful treatment target.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02508095 | TRI-CIRA 28 | Not available | Not available |
| 02401967 | TRI-CIRA LO 21 | Not available | Not available |
| 02486318 | TRI-JORDYNA 28 | Not available | Not available |
| 02508087 | TRI-CIRA 21 | Not available | Not available |
| 02486296 | TRI-JORDYNA 21 | Not available | Not available |
Showing 5 of 6 valid authorizations. The sixth is TRI-CIRA LO 28 (DIN 02401975).
Safety Considerations
- Contraindication-related conditions (TxGNN model associations, not label text): The TxGNN model (deep learning) links norgestimate to contraindications in the following groups. These links may reflect similarities the model learned between related diseases, not biological evidence. These need verification against the official label.
- Cardiovascular and metabolic: hypertensive disorder, hypertension, diabetes mellitus, diabetic ketoacidosis, hyperglycemia, hypertriglyceridemia
- Liver, kidney and gallbladder: liver disease, gallbladder disease, kidney disease
- Neurological and psychiatric: epilepsy, anxiety disorder, neurotic disorder, dysthymic disorder
- Porphyria: inherited porphyria, porphyrin metabolism disease, porphyria
- Thyroid: hypothyroidism, myxedema, congenital hypothyroidism
- Immune and respiratory: systemic lupus erythematosus (including pediatric), asthma (intrinsic and allergic)
- Calcium and phosphorus disorders: hypercalcemia, humoral hypercalcemia of malignancy, nephrocalcinosis, phosphorus metabolism disease
- Oncology: female breast carcinoma
- Drug Interactions: 38 interactions were recorded in total. Examples of those rated Major are:
- Sugammadex
- Griseofulvin
- Bexarotene
- Brigatinib
- Dabrafenib
- Encorafenib
Examples of Moderate interactions are metreleptin, miltefosine, adalimumab, anakinra, cladribine, enasidenib and entrectinib. Rosuvastatin and ethanol are rated Minor.
Package insert warnings and contraindications are not available in the compiled data. Please refer to the package insert for the full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests solely on a model score, with no clinical trials, no literature and no identifiable mechanistic link. The proposed target is a laboratory finding rather than a treatable disease, and the drug has a wide set of knowledge-graph contraindications.
To proceed, the following is needed:
- The Health Canada package insert (warnings, contraindications, approved indications), which is required before any safety screening
- Mechanism of action data, for example from DrugBank
- Literature review on hormonal contraceptives and plasma zinc
- Evidence that elevated plasma zinc is a clinically meaningful treatment target
- Assessment of the contraindication burden and drug interactions for any proposed population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.