Synmosa Introduces Novel Drug from Japan’s EA Pharma World’s First IBAT Inhibitor for Chronic Constipation Approved in Taiwan, Launch Expected in April–June 2026

Synmosa Group (TW: 4114) today announced that the world’s first ileal bile acid transporter (IBAT) inhibitor for the treatment of chronic functional constipation has received regulatory approval in Taiwan and is expected to be launched in April–June 2026, offering a new therapeutic option for clinical practice. The drug, Goofice ® (Elobixibat), is licensed from Japan’s EA Pharma and is the world’s first IBAT inhibitor indicated for chronic functional constipation. With its novel mechanism of action, Goofice ® demonstrated a favorable safety profile and sustained efficacy in improving bowel movement frequency, stool consistency, and quality of life. Synmosa noted that the drug has completed clinical trials in Taiwan across ten medical centers and one regional hospital. Upon launch, Goofice ® will further strengthen Synmosa’s gastrointestinal portfolio and enhance its comprehensive presence in the digestive disease field. Oral IBAT Inhibitor Addresses Unmet Clinical Needs in Chronic Constipation Current treatments for chronic constipation in Taiwan mainly include stool softeners, lubricants, laxatives, stimulant laxatives, and osmotic agents. Many of these therapies require sufficient fluid intake; otherwise, they may worsen constipation or even lead to serious complications such as intestinal obstruction. Long-term use of laxatives or enemas may also reduce intestinal nerve sensitivity, impair normal bowel motility and defecation reflexes, and gradually diminish treatment efficacy. Elobixibat, the active ingredient in Goofice ® , is an ileal bile acid transporter inhibitor that works by blocking bile acid reabsorption in the ileum, thereby increasing bile acid levels in the colon. Bile acids improve chronic constipation symptoms by triple mode of action that promote water and electrolyte secretion into the colonic lumen, stimulate intestinal motility, and enhances rectal sensation, which increases the desire to defecate. According to a study published in The Lancet Gastroenterology & Hepatology in 2018, after one week of treatment, spontaneous bowel movements increased by an average of 6.40 times per week, compared with 1.73 times in the placebo group. The Bristol Stool Form Scale improved to an average score of 4.4, versus 2.5 in the placebo group (scores 1–2 indicate hard stools, 3–5 normal, and 6–7 loose stools). Long-term studies of up to 52 weeks demonstrated sustained improvements in both bowel movement frequency and stool consistency, with clinical efficacy recognized internationally. Constipation: A Hidden Epidemic with a Market Exceeding NT$800 Million in Taiwan Irregular eating habits and disrupted lifestyles have made chronic functional constipation an increasingly common health issue in Taiwan. According to a survey on constipation and dietary behavior conducted by the Taiwan Nutrition Foundation, nearly half (47.2%) of office workers suffer from long-term constipation, with prevalence increasing significantly with age. Among individuals aged 65 and above, constipation prevalence ranges from approximately 24% to 40%. Data from the Ministry of Health and Welfare’s 2018 National Health Insurance Medical Statistics Annual Report showed that approximately 1.4 million patients sought medical care for constipation, with women accounting for about twice the number of men. The National Health Insurance Administration also reported in 2023 that constipation medications ranked third in total prescription volume nationwide, with annual usage reaching 360 million tablets—comparable to gastric acid–suppressing drugs. The current constipation drug market in Taiwan exceeds NT$800 million and continues to grow at an annual rate of 6–8%. As Taiwan enters a super-aged society and dietary and lifestyle patterns continue to change, demand for gastrointestinal treatments is expected to rise steadily, underscoring the growing importance of effective constipation management. Strengthening Gastrointestinal Portfolio Through Continuous Expansion Synmosa Group has long been committed to the gastrointestinal therapeutic area, with a portfolio spanning both prescription and over-the-counter products. Its offerings include the prescription antidiarrheal K.B.T. TABLETS, as well as OTC brands such as gelfos ® M for gastroesophageal reflux disease, Phazin for digestion and bloating relief, and multiple enema products—collectively addressing diverse clinical and consumer gastrointestinal health needs. The upcoming launch of Goofice ® (Elobixibat) will provide a novel treatment option for patients with chronic constipation, filling a critical gap in constipation management and further strengthening Synmosa’s overall gastrointestinal product portfolio. About Synmosa Biopharma Corporation Established in 1980, Synmosa focuses on the multi-faceted development in the medical industry. Synmosa specializes in R&D, manufacturing, distribution, sales and marketing of new drugs, generics, OTC, and healthcare products. Synmosa is strong in respiratory, cardiovascular, sex hormones, urology, oncology oriented therapeutic products. Digestive system therapeutic area will be the next focus area. About EA Pharma EA Pharma, a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was established in April 2016 by integration of the gastrointestinal business unit with more than 60 years’ history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma is a gastrointestinal specialty pharma with a full value chain covering R&D, logistics and sales & marketing. Back

The release as fetched from its publisher. com.tw ↗