Expanded Access Policy
Access to investigational medicinal product
VectivBio’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, VectivBio believes 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 VectivBio’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.