Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A confirmatory Phase 3 trial of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support

Next Previous
Trial Profile

A confirmatory Phase 3 trial of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Apraglutide (Primary)
  • Indications Intestinal failure; Short bowel syndrome
  • Focus Pharmacokinetics; Registrational
  • Sponsors Ironwood Pharmaceuticals

Most Recent Events

  • 07 Aug 2025 According to an Ironwood Pharmaceuticals media release, company has been finalizing a confirmatory Phase 3 trial design and plan to align with the FDA in the fourth quarter. Pending alignment with the FDA, Ironwood expects to initiate a confirmatory Phase 3 trial in the first half of 2026.
  • 20 Apr 2025 New trial record
  • 14 Apr 2025 According to an Ironwood Pharmaceuticals media release, the company announced that, based on a recent discussion with the U.S. Food and Drug Administration (FDA), a confirmatory Phase 3 trial is needed to seek approval. The company plans to work with the FDA on the design of a confirmatory Phase 3 trial and the regulatory path forward.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top