Norgestimate
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Norgestimate: From Acne and Menopausal Conditions to Elevated Plasma Zinc
One-Sentence Summary
Norgestimate is a progestin, used in combination with ethinylestradiol, originally associated with acne and with postmenopausal conditions such as osteoporosis and atrophic vaginitis. The TxGNN model predicts it may be relevant to elevated plasma zinc, but there are no clinical trials and no publications supporting this direction, so the prediction rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Acne; postmenopausal osteoporosis; osteoporosis; atrophic vulva; postmenopausal atrophic vaginitis (from the knowledge graph, as no approved indication text is available for the UK authorisation) |
| Predicted New Indication | Zinc, elevated plasma |
| TxGNN Prediction Score | 99.06% |
| Evidence Level | L5 |
| UK Market Status | Marketed |
| Number of Marketing Authorisations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, norgestimate is a progestin that is normally combined with ethinylestradiol in oral contraceptive products.
No established mechanistic link to elevated plasma zinc has been identified. The only support is the high TxGNN knowledge-graph score. Oral contraceptive oestrogens are known to raise serum copper and may modestly alter circulating zinc. This is a general hormonal effect on trace-element binding proteins rather than a documented therapeutic action.
Elevated plasma zinc is also a laboratory finding rather than a disease with a clear treatment target, so the indication itself is questionable. Any apparent link is speculative and unsupported by evidence. Similarity to the original indications has not yet been assessed.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
UK Market Information
| Marketing Authorisation Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 0703010G0AAACAC (NHS BNF code) | Ethinylestradiol/Norgestimate tablets 35 micrograms/250 micrograms | Tablet | Not stated |
The product is a single-ingredient-listed authorisation record that is currently valid. BNF classification lies within chapter 7 (obstetrics, gynaecology and urinary-tract disorders), section 7.3.1 (combined hormonal contraceptives), as indicated by the code prefix 0703010. Dosage form and approved indication text were not available in the data compiled for this report.
Safety Considerations
Contraindication signals from the knowledge graph (these are model-derived drug–disease links, not label text, and should be checked against the SmPC):
- Cardiovascular and metabolic: hypertensive disorder, hypertension, diabetes mellitus, diabetic ketoacidosis, hyperglycaemia, hypertriglyceridaemia
- Hepatic and biliary: liver disease, gallbladder disease
- Renal: kidney disease, pyoureter, nephrocalcinosis
- Neurological and psychiatric: epilepsy, anxiety disorder, neurotic disorder, dysthymic disorder
- Metabolic and endocrine: inherited porphyria, porphyria, porphyrin metabolism disease, hypothyroidism, myxoedema, congenital hypothyroidism, hypercalcaemia, humoral hypercalcaemia of malignancy, phosphorus metabolism disease
- Immunological and respiratory: systemic lupus erythematosus (including paediatric), asthma (intrinsic and allergic)
- Oncological: female breast carcinoma
Drug Interactions: 38 interactions were recorded. Major-level interactions among those listed include:
- Sugammadex
- Griseofulvin
- Bexarotene
- Brigatinib
- Dabrafenib
- Encorafenib
Moderate-level interactions include metreleptin, miltefosine, adalimumab, alefacept, anakinra, asparaginase Escherichia coli, canakinumab, certolizumab pegol, cladribine, emapalumab, enasidenib and entrectinib. Minor-level interactions include rosuvastatin and ethanol.
Please refer to the SmPC and BNF for full safety information. Report suspected adverse reactions via the Yellow Card Scheme.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score, with no trials, no literature and no plausible mechanistic link. Elevated plasma zinc is a laboratory finding rather than a treatable disease, so the proposed indication is itself questionable.
To proceed, the following is needed:
- Mechanism of action data for norgestimate
- Label warnings and contraindications from the SmPC and BNF, as these are currently missing and block safety screening
- Evidence that elevated plasma zinc is a clinically meaningful treatment target
- Any preclinical or observational data linking norgestimate to zinc handling
- Approved indication text and dosage form for the UK authorisation
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.