Gemeprost
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Gemeprost
- Gemeprost: From Obstetric Use (Cervical Softening and Pregnancy Termination) to Atypical Coarctation of Aorta
Gemeprost: From Obstetric Use (Cervical Softening and Pregnancy Termination) to Atypical Coarctation of Aorta
One-Sentence Summary
Gemeprost is a prostaglandin E1 (PGE1) analogue, supplied in Singapore as a vaginal pessary for obstetric use. The TxGNN model predicts it may be effective for atypical coarctation of aorta, but no clinical trials and no publications currently support this prediction. The top-ranked prediction is a network-based score only, and the evidence points to a recommendation to hold.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence record. The published literature describes use for medical termination of early pregnancy and cervical preparation. |
| Predicted New Indication | Atypical coarctation of aorta |
| TxGNN Prediction Score | 99.53% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, gemeprost is a PGE1 analogue that acts on prostaglandin E (EP) receptors. It causes smooth muscle contraction, cervical ripening and uterine contractions.
The predicted indication is a structural defect of the aorta. PGE1 is used in newborns to keep the ductus arteriosus open in ductal-dependent heart lesions. That is a different use from treating structural coarctation, and it does not provide a mechanistic basis for gemeprost. Gemeprost is also an intravaginal pessary for obstetric use, so no plausible route or use case is evident.
The high TxGNN score therefore reflects a network-based association only. It should not be read as evidence of therapeutic benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for the top-ranked prediction (atypical coarctation of aorta).
The literature found for other predictions is context only. The most relevant items are listed below.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 1525104 | 1992 | RCT / comparative study | Br J Obstet Gynaecol | Gemeprost alone vs mifepristone plus gemeprost for medical abortion up to 56 days of amenorrhoea |
| 1751434 | 1991 | RCT | Br J Obstet Gynaecol | Cervical preparation before first-trimester vacuum aspiration: gemeprost vs mifepristone |
| 1322621 | 1992 | Clinical study | Acta Obstet Gynecol Scand | Mifepristone followed by a prostaglandin analogue in 16,369 women; overall success rate 95.3% |
| 18185889 | 2007 | Case report | Ann Acad Med Singapore | Acute myocardial infarction after insertion of a gemeprost vaginal pessary |
| 10904996 | 2000 | Case report / series | Zentralbl Gynakol | Severe cardiovascular complications (cardiogenic shock due to vasospasm, stroke) after gemeprost |
| 11187221 | 2000 | Case report | Ugeskr Laeger | Vasospastic angina after medical abortion with mifepristone and gemeprost |
| 7834185 | 1994 | Preclinical (human tissue) | Br J Pharmacol | EP3-receptor agonists cause potent contraction of human isolated pulmonary artery |
These studies concern pregnancy termination or cardiovascular adverse events. They do not support a new indication. The amenorrhoea literature refers to gestational age in early pregnancy, not amenorrhea as a disease.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN02475P | CERVAGEM VAGINAL PESSARY 1 mg | Suppository (vaginal pessary) | Not stated in the licence record |
Manufacturer: Ono Pharmaceutical Co Ltd.
Safety Considerations
- Cardiovascular events: Published case reports link gemeprost to acute myocardial infarction, coronary vasospasm, vasospastic angina, cardiogenic shock and stroke. These reports are a signal of concern for any vascular or cardiac indication.
- Vascular effects: EP3-receptor agonists cause contraction of human pulmonary artery in vitro, which suggests a potentially adverse effect in pulmonary hypertension.
- Other: A case of uterine artery pseudoaneurysm with postpartum haemorrhage has been reported after second-trimester termination with gemeprost.
Please refer to the package insert for formal warnings, contraindications and drug interaction information.
Conclusion and Next Steps
Decision: Hold
Rationale: The top prediction, atypical coarctation of aorta, has no trials or literature and no plausible mechanism. Gemeprost is an obstetric vaginal pessary with reported vasospastic and cardiovascular adverse events. The other nine predictions in the ranked list are mostly L5 and also rated Hold. The amenorrhea and vascular disease entries show literature, but it reflects existing obstetric use or safety concerns, not repurposing potential.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA website
- Mechanism of action data from DrugBank
- Any preclinical or clinical evidence specific to the predicted indication
- A route and formulation rationale, since a vaginal pessary is not suited to a cardiovascular indication
- A cardiovascular safety assessment before any vascular indication is considered
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.