ELGAN Pharma and the EIC Accelerator: Insulin for Premature Guts

ELGAN Pharma, based in Nazareth, Israel, develops ELGN-GI (also called ELGN-2112), a formulation of human insulin given through the gut to premature babies. Insulin is naturally present in amniotic fluid and breast milk and helps the intestine mature; the drug is meant to act locally and help babies born before 32 weeks move sooner from intravenous to normal feeding. The EIC project said it cut four days of intravenous nutrition and about seven days in hospital, and contributed to a 40% reduction in life-threatening infections and necrotising enterocolitis, according to CORDIS.

The European Innovation Council granted €2,359,000 towards a €3.37 million project from November 2022 to October 2024 to prepare a new Phase 3 trial. The final report lists regulatory submissions, site contracts, manufacture of drug and placebo and certified clinical batches, and says the trial "would start imminently". In June 2025 ELGAN and the Italian drug maker Chiesi announced the first infants dosed in FIT-PIV, designed for 420 infants at about 50 sites. The report describes an earlier Phase 3 with more than 300 infants as showing the drug "safe and effective"; on ClinicalTrials.gov that trial is listed as terminated by "sponsor decision" in 2018.

Where ELGAN Stands Now

FIT-PIV opened in February 2025 and is registered with an estimated completion in May 2029 on ClinicalTrials.gov, where its listed sites are so far in Israel; Chiesi said it would open in the UK, Europe, Israel and the US. Its main measure is the number of days until babies reach full feeding by mouth or tube. In October 2025 ELGAN also started a 60-infant safety study in babies born before 26 weeks or with restricted growth. Chiesi describes the drug as developed in collaboration with ELGAN; the financial terms have not been published.

The Technology: Helping the Gut Mature

Premature babies often cannot absorb nutrition, so they are fed intravenously, which carries risks of infection and does not fully support growth. ELGN-2112 is mixed into their feeds; the company says it increases the intestine's absorptive surface and speeds maturation without entering the bloodstream. The report adds that investigators found microbiome changes after treatment that may explain lower rates of necrotising enterocolitis, a finding still under review.

What the EIC Project Promised, and What CORDIS Shows

The grant paid for everything needed to launch the Phase 3: approvals, manufacturing, vendors and systems. That was delivered, and the trial started within months of the project's end. The treatment's benefit, the reason for the EIC's backing, will be tested only when the trial reports. CORDIS lists the project as closed.

1. Trial approvals and sitesDeliveredPer final report.
2. Clinical drug supplyDeliveredActive and placebo.
3. Phase 3 launchDeliveredFirst dosing, June 2025.
4. Efficacy provenPendingResults due around 2029.

The Money

ELGAN has not published its accounts or the terms of its partnership with Chiesi, and no EIC Fund investment has been announced. The drug was earlier developed by Nutrinia under the name NTRA-2112, which announced the first patient in that Phase 3, FIT-04, in November 2016; ELGAN is now listed as the sponsor of that earlier terminated trial.

What Cannot Be Checked

Why Europe Should Care

The report says about 10% of babies are born premature, and ELGN-2112 could be the first drug for their intestinal malabsorption. The EIC grant helped restart the path to approval, and a European drug company has joined. The earlier stopped trial is a reason for caution until new data arrive.

The Verdict

ELGAN Pharma and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.