If you are a drug manufacturer dealing with a lack of treatments for orphan neonatal diseases — this project developed an oral insulin-based medication that is safe and effective. It targets infants born before 32 weeks of gestation to accelerate GI development.
Oral Therapy to Accelerate Gut Maturation and Reduce Hospital Stays for Preterm Infants
Imagine a baby born too early whose stomach is like an unfinished puzzle—it can't yet absorb the food it needs to grow. Instead of relying on risky IV drips, this treatment uses a special form of insulin that acts like a 'jump-start' for the gut. It helps the digestive system mature faster so the baby can start eating normally much sooner.
What needed solving
Preterm infants often cannot absorb nutrients, forcing reliance on risky central line nutrition. This leads to longer hospital stays and a high risk of life-threatening infections.
What was built
A GMP-manufactured oral insulin-based drug and the complete clinical trial infrastructure, including submission packages and site contracts.
Who needs this
Who can put this to work
If you are a NICU operator dealing with high bed-occupancy and infection risks — this project developed a therapy that reduces hospitalization by ~7 days and cuts life-threatening infections by 40%.
If you are a distributor dealing with the need for high-standard neonatal drug delivery — this project developed a GMP-manufactured, labeled, and packaged drug product ready for phase III clinical trials.
Quick answers
What is the cost or price of the therapy?
Based on available project data, the specific price per dose or treatment cost is not mentioned.
Is the production ready for industrial scale?
The project successfully completed GMP manufacturing, including active medication and placebo, with qualified analytical laboratories for release and stability testing.
What is the IP or licensing status?
Based on available project data, specific patent or licensing details are not provided, though the drug is being prepared for marketing authorization filing.
What is the regulatory timeline?
The project has completed preparations for the final phase III trial, which is the last study required before filing for marketing authorization.
How does this integrate into current NICU workflows?
It replaces or reduces the duration of parenteral nutrition (central line nutrition) by stimulating the gut to transition to oral nutrition faster.
Who built it
The project is led by a single Israeli SME, Elgan Pharma Ltd. This 100% industry-led structure indicates a highly focused commercial drive, avoiding the typical delays of academic-industrial partnerships and moving directly toward clinical validation and market entry.
Contact Elgan Pharma Ltd. regarding the upcoming phase III trial results.
Talk to the team behind this work.
Contact us to explore licensing opportunities for this neonatal GI therapy.