Alprostadil
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Alprostadil: Aortic malformation
One-Sentence Summary
Alprostadil is a prostaglandin E1 analogue given by injection that relaxes smooth muscle and keeps the ductus arteriosus open in newborns. The TxGNN model predicts it may be useful for aortic malformation. Support is limited to 8 publications (case reports, reviews and small clinical studies) and no registered clinical trials.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Aortic malformation |
| TxGNN Prediction Score | 0.9998 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (5 of 5) – CDSCO approval status is not included in this data |
| Number of Listed Products | 5 (valid: 5) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Alprostadil is prostaglandin E1 (PGE1). Published clinical literature describes it relaxing the smooth muscle of the ductus arteriosus, which dilates the duct and keeps it open.
In newborns whose circulation depends on an open duct, such as those with certain obstructive aortic arch lesions (for example interrupted aortic arch), keeping the duct patent supports blood flow until surgery. The literature includes an infant with interrupted aortic arch type B who received alprostadil to hold the duct open before single-stage repair.
This prediction therefore reflects an established clinical practice more than a novel repurposing idea. Secondary anti-inflammatory and organ-protective effects, such as reduced lung injury after cardiopulmonary bypass in children with congenital heart disease, are plausible but come from indirect or preclinical work.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 6763200 | 1982 | Review / clinical evaluation | Pharmacotherapy | Alprostadil infusion dilates the ductus arteriosus and increases pulmonary blood flow in infants with congenital heart malformations |
| 19068708 | 2008 | Case report | Kyobu Geka | Neonate with interrupted aortic arch type B; alprostadil kept the duct open before single-stage repair |
| 19080093 | 2008 | Clinical study | Zhonghua Yi Xue Za Zhi | Alprostadil with ulinastatin studied for inflammatory response and lung injury after cardiopulmonary bypass in children with congenital heart disease |
| 30184041 | 2018 | Case report | Braz J Cardiovasc Surg | Aortopulmonary window repair; alprostadil and milrinone used before surgery to counter high lung pressure |
| 15362549 | 2004 | Review | Kyobu Geka | Alprostadil keeps the duct open in transposition of the great arteries before the arterial switch operation |
| 41167776 | 2025 | Retrospective cohort | Zhonghua Fu Chan Ke Za Zhi | Delivery mode and timing in 123 fetuses with complex congenital heart disease |
| 42469655 | 2026 | Retrospective cohort | BMC Pregnancy Childbirth | Pregnancy and perinatal management of complex fetal congenital heart disease |
| 20029353 | 2009 | Preclinical (rat) | Minerva Chir | Alprostadil reduced skeletal muscle ischaemia-reperfusion injury markers in rats |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 26832 | Bioglandin 500mcg Injection | Vial of 1 injection | Not stated in the licence record |
| 889 | Alpostin 500mcg Injection | Vial of 1 ml injection | Not stated in the licence record |
| 178514 | Prostaver 500mcg Injection | Vial of 1 injection | Not stated in the licence record |
| 175756 | Prostin VR 500mcg Injection | Vial of 1 ml injection | Not stated in the licence record |
| 175429 | Prostal Injection | Vial of 1 ml injection | Not stated in the licence record |
Safety Considerations
- Drug Interactions: 59 interactions are recorded. Those rated Moderate include canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, lorcaserin and sapropterin. Others, such as morphine, metformin, omeprazole, prednisone and vancomycin, have no rated severity.
- Neonatal safety signals in the literature: Prolonged infusion has been linked to gastric outlet obstruction (antral foveolar hyperplasia and hypertrophic pyloric stenosis) and to iatrogenic pseudo-Bartter syndrome in neonates, so close monitoring is needed.
For other safety information, please refer to the package insert.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Published reports support alprostadil for keeping the duct open in infants with aortic arch lesions, but the evidence is mostly case reports and reviews with no registered trials. Safety signals with prolonged neonatal infusion call for monitoring.
To proceed, the following is needed:
- Package insert warnings and contraindications for the marketed Indian products
- Mechanism of action data
- Controlled clinical data on aortic malformation specifically
- A neonatal infusion monitoring plan covering duration, gastric outlet and electrolyte effects
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.