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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

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

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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.