Clinical Trials Pipeline & In-Development

Glepaglutide

also known as: ZP1848

Zealand Pharma's long-acting GLP-2 analog for short-bowel syndrome — Phase 3 EASE program completed 2023 with mixed results (primary endpoint not met in EASE-1 under the prespecified analysis, though post-hoc and secondary analyses were positive); regulatory path under review.

A long-acting GLP-2 analog (Zealand Pharma) developed as a twice-weekly SC therapy for short-bowel syndrome — the EASE Phase 3 program completed 2023; EASE-1 missed its primary endpoint of weekly PN reduction under the prespecified analysis, though the open-label extension and secondary endpoints supported sustained effect. Zealand's regulatory path forward remains under review as of this writing.

Mechanism of action

GLP-2 receptor agonism with the same intestinotrophic mechanism as teduglutide — enterocyte proliferation, villous expansion, improved nutrient absorption — but administered less frequently owing to extended half-life.

Primary uses

Short-bowel syndrome (Phase 3 complete)

Typical dosing

10 mg twice weekly (subcutaneous)

EASE Phase 3 used 10 mg SC twice weekly.

Regulatory status

Not approved. Phase 3 EASE program (EASE-1, EASE-2, EASE-3) completed 2023 with mixed primary-endpoint results; regulatory path under Zealand Pharma review.

References

[manufacturer] Zealand Pharma. Press release: EASE-1 Phase 3 topline results, 2023.
[clinicaltrials] ClinicalTrials.gov NCT05022264 (EASE-1) and related EASE program studies.

Related peptides

Teduglutide

FDA-approved GLP-2 analog (Gattex/Revestive, 2012) for short-bowel syndrome — the first disease-modifying treatment for SBS, reducing parenteral nutrition dependence by promoting intestinal mucosal growth.

Apraglutide

Ironwood's weekly GLP-2 analog for short-bowel syndrome — STARS Phase 3 positive (2024), NDA submitted to FDA 2025; potentially the first once-weekly SBS therapy and a meaningful improvement over teduglutide's daily dosing.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.