Astellas Pharma and Ironwood Pharmaceuticals announced that the Phase III clinical trial of Linaclotide conducted in Japan in adults with irritable bowel syndrome with constipation met its primary endpoints. Astellas expects to submit a New Drug Application to Ministry of Health, Labor and Welfare in Japan in 2016.
Linaclotide is a guanylate cyclase-C agonist currently approved in the United States for the treatment of adults with IBS-C and chronic idiopathic constipation. It is also approved for adults with IBS-C or CIC in more than 30 other countries.
For more details visit: PHASE III OF IBS-C TRIAL