In Development Pipeline & In-Development

Apraglutide

also known as: FE 203799, apraglutide acetate

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.

A long-acting GLP-2 analog originated by Ferring and in-licensed by Ironwood Pharmaceuticals — STARS Phase 3 in adult short-bowel syndrome reported positive topline results in 2024 (reduction in weekly PN volume, with significantly higher rates of PN independence than placebo at 24 weeks); NDA submitted to FDA in 2025 with potential for approval 2026, offering once-weekly dosing that would substantially reduce injection burden vs daily teduglutide.

Mechanism of action

GLP-2 receptor agonism with same intestinotrophic mechanism as teduglutide and glepaglutide. Albumin binding extends half-life.

Primary uses

Short-bowel syndrome (Phase 3 positive; NDA under review)

Typical dosing

5 mg once weekly (subcutaneous)

STARS Phase 3 used 5 mg SC once weekly.

Regulatory status

Not yet approved. STARS Phase 3 in SBS completed 2024 with positive topline; NDA submitted 2025.

References

[manufacturer] Ironwood Pharmaceuticals. Press release: STARS Phase 3 topline positive results, 2024.
[clinicaltrials] ClinicalTrials.gov NCT04964986 (STARS Phase 3).

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.

Glepaglutide

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.

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.