Drospirenone
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Drospirenone: From Acne and Postmenopausal Atrophic Vaginitis to Elevated Plasma Zinc
One-Sentence Summary
Drospirenone is a progestin with anti-mineralocorticoid and anti-androgenic activity. Its original indications in the knowledge graph are acne and postmenopausal atrophic vaginitis (including atrophic vulva). The TxGNN model predicts it may be effective for elevated plasma zinc, but there are 0 clinical trials and 0 publications supporting this specific prediction. This is a model-only prediction with no direct evidence.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Acne; postmenopausal atrophic vaginitis; atrophic vulva (from the knowledge graph; no approved indication text is available in the Singapore licence records) |
| Predicted New Indication | Zinc, elevated plasma |
| TxGNN Prediction Score | 98.74% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 6 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available. Based on known information, drospirenone is a progestin that resembles progesterone and, like its parent compound spironolactone, has anti-mineralocorticoid and anti-androgenic activity. Its anti-androgenic effect is consistent with its use in acne.
However, no identifiable mechanistic link connects drospirenone to the regulation of plasma zinc. The high TxGNN score (0.987) most likely reflects relationships within the knowledge graph rather than a biological rationale. At present this is a hypothesis generated by the model, without clinical or literature support.
Note that the model's other top-ranked predictions (ranks 2–10) are mostly rare congenital syndromes, and none of them has clinical trial support. Literature retrieved for some of them concerns premenstrual syndrome and polycystic ovary syndrome, and appears to be matched to the drug rather than to the predicted disease. It should not be read as support for these predictions.
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 |
|---|---|---|---|
| SIN16354P | SLINDA Film-Coated Tablets 4 mg | Film-coated tablet | Not stated in the records |
| SIN14996P | GVEZA Film-Coated Tablets 3 mg/0.03 mg | Film-coated tablet | Not stated in the records |
| SIN14995P | JASTINDA Film-Coated Tablets 3 mg/0.02 mg | Film-coated tablet | Not stated in the records |
| SIN12334P | YASMIN Tablet | Film-coated tablet | Not stated in the records |
| SIN14855P | DROSPERA Film-Coated Tablets 3 mg/0.02 mg | Film-coated tablet | Not stated in the records |
A sixth licence (SIN14894P, LIZA Film-Coated Tablets 3 mg/0.03 mg) is also valid. All six registrations are oral film-coated tablets.
Safety Considerations
The knowledge graph lists the following conditions as contraindications for drospirenone. These come from graph relationships, not from package insert text, and should be verified against the label:
- Cardiovascular/metabolic: hypertensive disorder, hypertension, diabetes mellitus, diabetic ketoacidosis, hypertriglyceridemia
- Renal/hepatic: kidney disease, liver disease, gallbladder disease
- Endocrine: adrenocortical insufficiency, Addison disease, hypothyroidism, myxedema
- Mineral metabolism: hypercalcemia, nephrocalcinosis, phosphorus metabolism disease
- Neurological/psychiatric: epilepsy, anxiety disorder, neurotic disorder, dysthymic disorder
- Others: porphyria, systemic lupus erythematosus, asthma
Drug interactions: 100 interactions were identified in total. The most notable is clarithromycin (Major). Many moderate interactions involve antidiabetic drugs (e.g. acarbose, glimepiride, glipizide, glyburide, dapagliflozin, empagliflozin, canagliflozin, saxagliptin, alogliptin, exenatide, dulaglutide), as well as aprepitant, acetylsalicylic acid, clotrimazole and potassium citrate.
Package insert warnings were not available for this report. Please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score. There are no clinical trials or literature, and there is no known biological link between drospirenone and plasma zinc. Elevated plasma zinc is also a laboratory finding rather than a well-defined treatable disease. The evidence level is L5.
To proceed, the following is needed:
- Detailed mechanism of action data (MOA) from DrugBank
- Package insert warnings and contraindications from the HSA website
- A clear clinical definition of the target condition and a plausible biological mechanism linking drospirenone to zinc regulation
- Preclinical or observational data showing any effect on plasma zinc
- Consideration of better-supported alternatives from the original indication family (e.g. acne, hyperandrogenic conditions), where literature already exists
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.