▼SetbackUS20 Dec 20241 min read
FDA turns back glepaglutide and asks for another trial
Zealand’s long-acting GLP-2 for short bowel syndrome gets a complete response letter, sending the programme back a stage on our board.
Filed → Phase 3 A rejection, a miss or a delay that pushes patients further away.
The readMixed dose results invite a rejection. When only one of two tested regimens works, a regulator can reasonably ask for proof that the chosen one does.
The letter
The FDA issued a complete response letter for glepaglutide in short bowel syndrome. Zealand said the agency wanted an additional clinical trial to confirm the effect on the need for parenteral support.
Why it happened
The main phase 3 trial, EASE-1, tested two regimens. Twice-weekly dosing met the primary endpoint: a larger cut in weekly intravenous support than placebo. Once-weekly dosing did not reach statistical significance. A filing that leans on one positive arm out of two is open to questions, and the FDA asked for more data.
The board move
A complete response letter does not end a programme, but it means the molecule is back to gathering phase 3 evidence. We move glepaglutide from filed to phase 3 and mark the signal down.
| Twice weekly | Once weekly | |
|---|---|---|
| EASE-1 primary endpoint | Met | Not met |
| Status after CRL | New trial requested | — |
- Zealand kept the programme alive and said it would discuss the path forward with the FDA.
- Check the company announcement for the exact wording of the letter.
Design of the additional trial, and the European review that runs on a separate track.
Primary sourceZealand Pharma company announcement on the FDA complete response letter, December 2024
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