1. This is the world's first bile acid transporter inhibitor.
2. The bile acids flowing into the large intestine promote bowel movements by dual actions, i.e., fluid secretion and acceleration of large intestinal motility.
3. In the Japanese phase 3 study, the following effects to induce improvement were observed.
   
   • The changes in the frequency of spontaneous bowel movements^*1 and frequency of complete spontaneous bowel movements^*2 from Week 2 of the observation period to Weeks 1 and 2 of the treatment period were significantly larger in the GOOFICE^® 10 mg group than in the placebo group (p < 0.0001, analysis of covariance).
   • The percentage of the patients who experienced spontaneous bowel movements within 24 hours after the initial administration was 85.5% in the GOOFICE^® 10 mg group, which was significantly higher than the percentage in the placebo group (p < 0.0001, Fisher's exact test).
   • The median stool hardness based on the Bristol Stool Form Scale was significantly higher in the GOOFICE^® 10 mg group than in the placebo group at both Weeks 1 and 2 of the treatment period (Week 1 of the treatment period, 2.5 in the placebo group vs. 4.4 in the GOOFICE^® 10 mg group; and Week 2 of the treatment period, 2.7 in the placebo group vs. 4.2 in the GOOFICE^® 10 mg group; p < 0.0001 for both, Wilcoxon rank sum test).
4. In the long-term administration study^*3 (52 weeks), the status of bowel movements was maintained.
5. It directly acts on bile acid transporters in the terminal ileum and is minimally absorbed into the body.
6. The dosage regimen is oral administration of 10 mg once daily before meals, and the dose may be adjusted appropriately according to symptoms (maximum dose, 15 mg/day).
7. Adverse reactions (including abnormal laboratory test values) were observed in 292 out of 631 patients with chronic constipation (46.3%) who were evaluated for safety in Japanese clinical studies conducted before approval. Major adverse reactions were abdominal pain in 120 patients (19.0%) and diarrhea in 99 patients (15.7%).

For safety information, please refer to the adverse reactions in the product package insert and the safety results of clinical studies.

*1 Bowel movements that occur without laxative/enema or manual disimpaction
*2 Bowel movements that occur without laxative/enema or manual disimpaction without leaving the sensation of inadequate bowel movements
*3 The clinical study described in the fourth characteristics includes patients who used doses higher than the approved dose.