ENTEREG was approved by the FDA on May 20, 2008 to accelerate upper and lower gastrointestinal (GI) recovery following partial large or small bowel resection surgery with primary anastomosis.

The FDA lifted the clinical hold on the Entereg capsule investigational new drug application (IND) for POI. Adolor and GSK plan to commence a study in patients undergoing radical cystectomy, another population in which POI is a significant burden, as part of a postmarketing commitment.