drugset
Drugs / Apraglutide
last change Apr 2025 re-read 9 days ago

Apraglutide

Peptide

Developed for
short bowel syndrome · acute graft versus host disease
Investigated by
VectivBio AG

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed US (FDA) — short bowel syndrome 2025-01-29

“Ironwood has initiated the rolling new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for apraglutide” ironwoodpharma.com ↗

Trials 8

today NCT06002555 · Ph 1 NCT05995704 · Ph 1 NCT05706623 · Ph 1 NCT05415410 · Ph 2 NCT05018286 · Ph 3 NCT04964986 · Ph 2 NCT04627025 · Ph 3 NCT04699032 · Ph 1
20212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials · 1 met primary
Phase 1 NCT06002555 May → Sep 2023 — VectivBio AG Completed No outcome recorded
Phase 1 NCT05995704 Mar → Jul 2023 — VectivBio AG Completed No outcome recorded
Phase 1 NCT05706623 Jan → Apr 2023 — VectivBio AG Completed No outcome recorded
Phase 1 NCT04699032 Dec 2020 → Jul 2021 chronic kidney disease VectivBio AG Completed Met primary
Phase 22 trials · 2 met primary
Phase 2 NCT05415410 May 2022 → Dec 2024 acute graft versus host disease VectivBio AG Terminated Met primary
Phase 2 NCT04964986 Jun 2021 → Jun 2023 short bowel syndrome VectivBio AG Completed Met primary
Phase 32 trials · 1 met primary
Phase 3 NCT05018286 Jul 2021 → Oct 2027 expected short bowel syndrome VectivBio AG Active not recruiting No outcome recorded
Phase 3 NCT04627025 Jan 2021 → Jan 2024 short bowel syndrome VectivBio AG Completed Met primary

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2025-04-14 Ironwood Pharmaceuticals, Inc. Regulatory Ironwood Pharmaceuticals Provides Clinical and Regulatory Update on Apraglutide ironwoodpharma.com ↗
However, following recent dialogue with the FDA it became clear that a confirmatory Phase 3 trial is needed to seek approval.
2025-01-29 Ironwood Pharmaceuticals, Inc. Regulatory Ironwood Pharmaceuticals Initiates Apraglutide NDA Submission, Highlights Compelling New Data and Updates Corporate Structure to Position for the Future ironwoodpharma.com ↗
Initiated rolling NDA submission, now to include long-term extension data given continued clinical improvement over time, with submission completion expected in Q3 2025
2024-10-28 Ironwood Pharmaceuticals, Inc. Results Once-Weekly Apraglutide Showed Consistent Treatment Effect Across Baseline Demographics and Disease Characteristics in Adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF), According to New STARS Phase III Data from Ironwood at ACG 2024 ironwoodpharma.com ↗
2024-05-21 Ironwood Pharmaceuticals, Inc. Results Ironwood Late-Breaker Oral Presentation at Digestive Disease Week® Reinforces Potential of Once-Weekly Apraglutide for Adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF) ironwoodpharma.com ↗
New data highlight both stoma and colon-in-continuity (CIC) patients drove the positive primary endpoint with significant relative change from baseline in weekly parenteral support (PS) volume reduction at week 24
2024-03-28 Ironwood Pharmaceuticals, Inc. Results Ironwood Pharmaceuticals Announces Positive Results from its Phase II Exploratory STARGAZE Trial of Apraglutide in Patients with Steroid-Refractory Gastrointestinal Acute Graft-versus-Host Disease (SR GI aGVHD) ironwoodpharma.com ↗
Results up to Day 91 show that apraglutide in SR GI aGVHD was well-tolerated with an acceptable safety profile, the study’s primary objective
2024-02-29 Ironwood Pharmaceuticals, Inc. Results Ironwood Pharmaceuticals Announces Positive Topline Results from Global Phase III Trial of Once-Weekly Apraglutide in Adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF) ironwoodpharma.com ↗
Apraglutide met the primary endpoint of relative change from baseline in actual weekly parenteral support (PS) volume at week 24, driven by both stoma and colon-in-continuity populations
2023-10-16 Ironwood Pharmaceuticals, Inc. Results Ironwood Pharmaceuticals Presents Positive Final Data from STARS Nutrition, a Phase II Study of Apraglutide in Short Bowel Syndrome with Intestinal Failure (SBS-IF) and Colon in Continuity (CIC) at United European Gastroenterology Week ironwoodpharma.com ↗
Seventy-eight percent (78%) of patients gained one or more days off PS with all patients achieving clinical response.

All press releases naming this drug 8 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Apraglutide ClinicalTrials.gov intervention name — accepted as the source's own label NCT06002555 ↗
7

NCT05415410 ↗

NCT04627025 ↗

NCT05706623 ↗

NCT04964986 ↗

NCT05995704 ↗

NCT04699032 ↗

NCT05018286 ↗
Action Activate “acts as a full agonist at the GLP-2 receptor” NCT04627025 ↗
Modality Peptide “Peptide analogue of GLP-2” NCT04627025 ↗
Route Subcutaneous “weekly SC injections of apraglutide” NCT04627025 ↗