Zealand Pharma’s Phase 3 Trial of Glepaglutide: A Potential Breakthrough for SBS Treatment

Zealand Pharma A/S ((ZLDPF)) announced an update on their ongoing clinical study.

Study Overview: Zealand Pharma A/S is conducting a Phase 3 clinical trial titled ‘A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)’. The study aims to confirm the efficacy and safety of glepaglutide in treating Short Bowel Syndrome with intestinal failure (SBS-IF), a condition that significantly impacts patients’ quality of life.

Intervention/Treatment: The trial tests the drug glepaglutide, administered as subcutaneous injections twice weekly. Glepaglutide is designed to improve intestinal absorption in patients with SBS-IF, potentially reducing the need for parenteral support.

Study Design: This interventional study uses a randomized, parallel assignment model. Participants are divided into two groups: one receiving glepaglutide and the other a placebo. The study employs quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are blinded to the group assignments. The primary purpose is treatment.

Study Timeline: The study is not yet recruiting, with a start date recently submitted on September 26, 2025. The primary completion and estimated completion dates are not provided, indicating the study is in its initial stages.

Market Implications: This study’s progress could influence Zealand Pharma’s stock performance, as successful results may enhance investor confidence and market position. The competitive landscape for SBS treatments includes other pharmaceutical companies developing similar therapies, which could impact market dynamics.

The study is ongoing, with further details available on the ClinicalTrials portal.