Drugs / Glepaglutide
Glepaglutide
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | short bowel syndrome | 2025-06-02 | “Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome” zealandpharma.com ↗ |
| Rejected (CRL) | US (FDA) | — | short bowel syndrome | 2024-12-19 | “U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome” zealandpharma.com ↗ |
| Filed | US (FDA) | — | short bowel syndrome | — | “Glepaglutide in short bowel syndrome (SBS). In December 2023, Zealand submitted an NDA to the U.S.” zealandpharma.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04318743 | Mar 2020 → Jun 2021 | — | Zealand Pharma | Completed | No outcome recorded |
| Phase 1 | NCT04178447 | Dec 2019 → Jul 2020 | impaired renal function disease | Zealand Pharma | Completed | No outcome recorded |
| Phase 1 | NCT03279302 | Sep → Dec 2017 | — | Zealand Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00868660 | Jan 2009 → Feb 2010 | inflammatory bowel disease | Zealand Pharma | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT02690025 | Feb 2016 → May 2017 | short bowel syndrome | Zealand Pharma | Completed | Met primary |
| Phase 36 trials · 1 missed | ||||||
| Phase 3 | NCT07197944 | Feb 2026 → Oct 2028 expected | short bowel syndrome | Zealand Pharma | Recruiting | No outcome recorded |
| Phase 3 | NCT07228403 | Dec 2025 → Sep 2028 expected | short bowel syndrome | Zealand Pharma | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04991311 | Aug 2021 → Feb 2023 | short bowel syndrome | Zealand Pharma | Completed | Missed primary |
| Phase 3 | NCT04881825 | Jun 2021 → Apr 2026 overdue | short bowel syndrome | Zealand Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03905707 | May 2019 → Apr 2026 overdue | short bowel syndrome | Zealand Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03690206 | Oct 2018 → Jul 2022 | short bowel syndrome | Zealand Pharma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-06-02 | Zealand Pharma | Regulatory Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome zealandpharma.com ↗ |
| 2024-12-19 | Zealand Pharma | Regulatory U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome zealandpharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the company’s New Drug Application (NDA) for glepaglutide, a long-acting GLP-2 analog |
All press releases naming this drug 4 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glepaglutide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03690206 ↗ |
| Known as | Glepaglutida | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297761 ↗ |
| Known as | ZP1848 | “Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.” NCT03905707 ↗ |
| Modality | Peptide | “Glepaglutide is a novel, long-acting, glucagon-like peptide-2 analogue in a stable aqueous formulation” PMID 36323988 ↗ Nov 2022 |
| Route | Subcutaneous | “SUBCUTANEOUS bolus injections” NCT00868660 ↗ |