Last update 24 Feb 2026
Sequence Code 14419995
12 Clinical Trials associated with Glepaglutide
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 purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data. Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.
Start Date 11 Feb 2026
Sponsor / Collaborator: Zealand Pharma A/S
A 104-week, Multicenter, Open-label, Single-arm, Phase 3 Extension Trial Investigating the Long-term Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Rolling Over From the EASE SBS 2 or 3 Trials
The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.
Start Date 11 Dec 2025
A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (SBS)
The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections. Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.
Start Date 10 Aug 2021
Sponsor / Collaborator: Zealand Pharma U.S., Inc.
100 Clinical Results associated with Glepaglutide
100 Translational Medicine associated with Glepaglutide
100 Patents (Medical) associated with Glepaglutide
15 Literatures (Medical) associated with Glepaglutide
Positive clinical outcomes associated with use of glucagon-like peptide-2 (GLP-2) analogues in patients with intestinal failure: A systematic review and meta-analysis
Review Author: Williams, Kyle ; Wong, Darren ; Bastas, Alysia
AIM: Glucagon-like peptide-2 analogues are part of the treatment algorithm for chronic intestinal failure to improve enteral nutrient absorption and reduce reliance on parenteral support. The purpose of this review is to update, consolidate and comprehensively evaluate the existing body of evidence, highlighting the breadth of positive clinical outcomes associated with glucagon-like peptide-2 analogue treatment.
Glucagon‐Like Peptide‐2 ( GLP ‐2) Analogues in Patients With Short Bowel Syndrome Dependent on Parenteral Support: A systematic review and meta‐analysis of randomized controlled trials
Review Author: Altaf, Faryal ; Hyder, Arsalan ; Jafar, Uzair ; Vhora, Farheen ; Jalal, Prasun Kumar ; Bhat, Adnan ; Hassan, Talha ; Niazi, Muhammad Arslan ; Ali, Eshah Fatima ; Zahra, Shah Gul ; Akram, Muhammad Faiq ; Khan, Shajia ; Rafiq, Adnan ; Cheema, Huzaifa Ahmad ; Rashad, Essam ; Alsubari, Asma'a Munasar Ali ; Alria, Ankit
ABSTRACT: Background and Objective: Short bowel syndrome (SBS) is a malabsorptive condition often requiring long‐term parenteral support (PS), which is associated with significant complications. Glucagon‐like peptide‐2 (GLP‐2) analogues are shown to enhance intestinal adaptation and reduce PS dependency. This systematic review and meta‐analysis aimed to evaluate the efficacy and safety of GLP‐2 analogues in adult patients with SBS dependent on PS.
Glepaglutide in Short Bowel Syndrome: Promising, But Questions Remain
Letter Author: Sharma, Gaurav
31 News (Medical) associated with Glepaglutide
'Several concerning observations': FDA sheds more light on reasons it rejected drugs
The FDA’s correspondence includes the decision not to approve Zealand Pharma’s GLP-2 drug glepaglutide for short bowel syndrome. The FDA’s ongoing effort to establish a culture of “radical transparency” saw the agency publish another haul of complete response letters (CRLs) yesterday.The latest batch of 89 rejection letters was uploaded Sept. 4 along with a pledge by the agency to begin publicly releasing this type of communication at the same time the documents are issued to sponsoring companies. As with the initial mailbag of more than 200 CRLs that the FDA made available back in July, a dive into yesterday’s letters sheds further light on the agency's often-opaque drug review process.Among the letters are some high-profile decisions for the likes of Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug RP1. The contents of the letters often map onto information already in the public domain, but there are still some fresh insights to be gleaned about the FDA’s decision-making process.‘Numerous unreported adverse events’The FDA’s correspondence certainly sheds more light on the agency’s decision at the end of last year not to approve Zealand Pharma’s GLP-2 drug glepaglutide in short bowel syndrome. That application—which could have set up glepaglutide as a possible challenger to Takeda’s Gattex—was based on results from a single placebo-controlled phase 3 study dubbed EASE-1.The trial hit its primary endpoint, with twice-weekly doses of glepaglutide reducing weekly parenteral support (PS) volume—a measure of tube feeding—by a statistically significant 5.13 liters at 24 weeks compared to baseline. However, once-weekly doses of glepaglutide failed to yield statistically significant reductions in PS.When Zealand announced that it had received the CRL in December 2024, the company didn’t divulge much detail, only confirming that the agency had “concluded that Zealand Pharma’s application did not meet the full requirements for substantial evidence to establish the efficacy and safety of the to-be-marketed dose of glepaglutide.”The full letter from the FDA, which was uploaded yesterday, gives a more detailed insight into the agency's rationale. While acknowledging the twice-weekly dosing endpoint win, the FDA pointed to “numerous uncertainties that limit the interpretability and/or persuasiveness of the results.”These included “observed inconsistencies” in PS as a result of adjustments outside of the trial’s protocol, according to the FDA. The inconsistencies “raise concerns that the observed changes in PS volume may have been impacted by factors other than the drug’s efficacy and may not accurately re
