Linaclotide, an investigational drug, is an agonist of the guanylate cyclase type-C (GC-C) receptor located on the luminal surface of the intestine.
The NDA for linaclotide was submitted for the treatment of IBS-C and CC following efficacy and safety results from a Phase 3 program.
The program, which included four double-blind placebo-controlled trials and two open-label long term safety studies, enrolled over 2,800 patients received a once-daily dose of either linaclotide or placebo.