Is Glepaglutide legal in the US?
Not yet; it is still in trials.
Glepaglutide is not approved by the FDA. Zealand Pharma filed a new drug application for short bowel syndrome and received a complete response letter in December 2024 asking for more evidence on the intended dose; a further phase 3 trial began enrolling in 2026. It is an investigational drug, not a research chemical. 1
No. The FDA issued a complete response letter in December 2024. It said the application did not establish how well and how safely the dose intended for marketing works. Only one of the two dosing arms in the main trial was positive. Zealand started another phase 3 trial in 2026 to answer that. 1
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Reference information only, not medical advice. Drawn from the Glepaglutide article, fact-checked against the cited sources. No dosing anywhere on this site.