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NCT05904626
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
Phase 2 trial testing ELGN-2112 in Intestinal Malabsorption in 60 participants. Currently enrolling.
1 June 2027
Quick facts
| Lead sponsor | Elgan Pharma Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 60 |
| Start date | 28 October 2025 |
| Primary completion | 1 June 2027 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- ELGN-2112 — full drug profile →
- Placebo
Conditions studied
- Intestinal Malabsorption — all drugs for Intestinal Malabsorption →
Sponsor
Elgan Pharma Ltd. — full company profile →
Who can join
Adults 1 Day to 5 Days, any sex, with Intestinal Malabsorption. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA
Time frame: Five days from birth until 42 days
Safety will be assessed by capturing of adverse events (AEs) during the treatment period. -
Compare the safety of treatment with ELGN-2112 to placebo in preterm infants born IUGR infants<3rd percentile* born at 26-32 weeks GA.
Time frame: Five days from birth until 42 days
Safety will be assessed by capturing of adverse events (AEs) during the treatment period.
Sponsor's own description
To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants\<3rd percentile\* born at 26-32 weeks GA.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05904626
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Elgan Pharma Ltd. trials
Trials by the same sponsor.
- NCT02865122 — Safety and Efficacy Study in Infant With SBS · Phase 2, PHASE3 · terminated
- NCT02510560 — Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05904626 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Elgan Pharma Ltd.
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05904626.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing