Our in-market product, LINZESS® (linaclotide), discovered in-house, is the branded prescription market leader in its class.
We are evaluating the safety and efficacy of apraglutide in a global Phase 3 clinical trial called STARS (STudy of ApRaglutide in SBS) in adults with short bowel syndrome with intestinal failure (SBS-IF).
Please see full LINZESS Prescribing Information below and a website dedicated to product-specific information.
For prescribing information please download this document. To review product information, please visit the Abbvie website at www.linzess.com.
To report any side effects experienced while taking LINZESS to AbbVie call 1-800-633-9110. Alternatively, you can report any side effects of prescription drugs directly to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Clinical Trial Transparency and Data Sharing
To learn more about our STARS clinical trial, please see the below website dedicated to the study of Apraglutide in SBS.
Expanded Access Policy
Ironwood’s lead investigational program is apraglutide, which is currently being investigated in clinical trials for the treatment of Short Bowel Syndrome with Intestinal Failure (SBS-IF). If successful, data generated during these clinical trials may provide the basis for drug approval submissions to regulatory authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), with the goal to develop new and innovative medicines.
In general, we believe that participating in clinical trials is the best way for patients to access medicines prior to approval.
Details about our clinical trials, including eligibility requirements for participating in ongoing or planned studies are published in public databases such as www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
Some patients may be interested in seeking access to investigational drugs before the regulatory approval of a drug via compassionate use or expanded access. At the current stage of drug development, it is Ironwood’s policy to provide access to apraglutide only as part of one of our clinical trials. This Policy may be reviewed and amended in the future.
