A randomized phase 2 study of the 5-HT₄ receptor agonist felcisetrag for postoperative gastrointestinal dysfunction...

Felcisetrag (5-hydroxytryptamine-4 receptor [5-HT₄] agonist) is under investigation as prophylaxis or active treatment for accelerating resolution of gastrointestinal function post-surgery.

Phase 2, randomized, placebo-controlled, parallel five-arm, double-blind, multicenter study (NCT03827655) in 209 adults undergoing open or laparoscopic-assisted bowel surgery. Patients received intravenous placebo, felcisetrag 0.1 mg/100 ​mL or 0.5 mg/100 ​mL pre-surgery only, or pre-surgery and daily post-surgery until return of gastrointestinal function or for up to 10 days.

time to recovery of gastrointestinal function.

Median time to recovery of gastrointestinal function was 2.6 days for both felcisetrag 0.5 ​mg daily and 0.5 ​mg pre-surgery versus 1.9 days for placebo (p ​> ​0.05). There were no notable differences in adverse events between treatment arms.

Felcisetrag was well tolerated with no new safety concerns. However, no clinically meaningful difference in time to recovery of gastrointestinal function versus placebo was observed. Further investigation of the utility of 5-HT₄ agonists in complicated, open abdominal surgeries may be warranted.