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Long-Acting Drug Delivery Empowers the Treatment of Rare Diseases, Unlocking New Pathways for Nutritional Absorption in Short Bowel Syndrome

In the field of metabolic diseases and intestinal dysfunction treatment, the development and clinical validation of every new drug carries the expectation of improving patients' quality of life. Glepaglutide (CAS No.: 914009-86-2), as a long-acting glucagon-like peptide-2 (GLP-2) analog, has gradually entered the research and clinical field in recent years with solid clinical research data, bringing new hope for the treatment of patients with short bowel syndrome (SBS).

Short Bowel Syndrome: A Precarious Situation, Urgent Clinical Needs

Short bowel syndrome is a severe intestinal failure disease. Patients suffer from malabsorption due to bowel resection and require long-term intravenous nutritional support (PS) to maintain life. This not only results in a low quality of life but also exposes them to various complications such as infection and thrombosis. The emergence of glepaglutide offers a new solution to this dilemma, and its core value has been confirmed in multiple clinical studies.

Key Clinical Study: EASE-1 Trial Confirms Efficacy and Safety

An international randomized, placebo-controlled phase 3 clinical trial (EASE-1) showed that in patients with short bowel syndrome and intestinal failure, twice-weekly subcutaneous injections of glepaglutide effectively reduced the need for intravenous nutritional support and were well-tolerated. This study enrolled 106 patients who were randomly assigned to receive the treatment. Results showed that compared to the placebo group, the glepaglutide treatment group had a significantly lower weekly intravenous nutritional volume at week 24, with 65.7% of patients achieving a clinical response (≥20% reduction in intravenous nutritional volume), and 14% achieving complete withdrawal of intravenous nutrition, compared to 0% in the placebo group.

Mechanism of Action and Clinical Progress: From Mechanism to Implementation, Empowering Patient Treatment

As a long-acting GLP-2 analog, Glepaglutide mimics the physiological functions of natural GLP-2 in the human body, promoting intestinal mucosal growth and improving intestinal absorption, thus fundamentally helping patients with short bowel syndrome reduce their dependence on intravenous nutrition. Based on the results of this pivotal Phase 3 trial, Zealand Pharma has submitted a marketing authorization application to the EMA for Glepaglutide for the treatment of adult patients with short bowel syndrome, and the therapy has received orphan drug designation from the US FDA.

Long-Acting Advantage and Long-Term Validation: Enhancing Adherence and Strengthening Evidence-Based Basis

Compared to similar drugs, Glepaglutide's long-acting characteristics offer significant advantages. The twice-weekly dosing regimen greatly improves patient adherence and avoids the inconvenience of frequent injections. Currently, interim results from two long-term extension trials (EASE-2 and EASE-3) further validate its safety and efficacy for long-term use, providing stronger evidence-based support for its clinical application. From basic research to clinical validation, every step forward with Glepaglutide (914009-86-2) has injected new energy into the treatment of short bowel syndrome, a rare disease.