Elobixibat for Constipation: More Bowel Movements, Less Certain Bloating Relief

At a constipation follow-up, “I go more often” and “my belly feels better” are separate answers. A trial can support the first without establishing the second.

What improved in the Indian trial

The 2025 report randomized 150 adults, including 50 women, to elobixibat or placebo for two weeks. The analysis included 146. Weekly spontaneous bowel movements increased by an adjusted 3.83 with elobixibat versus 2.68 with placebo, a significant difference of 1.15 movements per week. Movements within 24 hours of rescue medication were excluded.¹

Bloating, abdominal discomfort, straining and stool consistency did not differ significantly between groups. Two weeks cannot establish lasting control. Dr Reddy’s Laboratories funded and conducted it; seven authors were employees.¹

What the older Japanese studies add

A 2018 report included a two-week placebo-controlled trial with 133 people randomized, supporting short-term improvement in spontaneous bowel movements. It also reported a separate 52-week open-label study, with 340 people in its safety analysis. The latter had no placebo group.²

In that year-long study, 48% experienced an adverse drug reaction. Abdominal pain affected 24% and diarrhea 15%; these were described as mild. EA Pharma and Mochida Pharmaceutical funded the studies. Longer observation adds information about treatment experience, but the uncontrolled design cannot establish a year-long advantage over placebo.²

Different follow-up lengths and event definitions prevent a direct safety ranking of these studies.¹²

Check the prescribing context

Japan’s GOOFICE label, revised April 2022 and currently posted by PMDA, covers chronic constipation excluding constipation caused by organic disease. It contraindicates treatment when bowel obstruction is confirmed or suspected.³

The label warns about abdominal pain and diarrhea and calls for periodic review of whether treatment should continue. Interactions include possible increases in digoxin or dabigatran blood levels and reduced effect with certain bile-acid-binding medicines or aluminum-containing antacids. This Japanese label does not establish authorization or availability in another country.³

Agree on more than a stool target

In “Time It: Your Belly Clock” in Bloated by Dinner, the log records bowel-movement timing and Bristol stool type alongside the timing of bloating, pain and urgency. It distinguishes felt pressure from visible swelling and includes medicines and supplements.

Bring those separate observations to the review. Ask which symptom the prescription is intended to improve, how long to assess it and what degree of pain or diarrhea should trigger contact. Our constipation-medicine guide covers the US guideline’s options.

Seek care right away for constipation accompanied by blood in the stool, constant abdominal pain, inability to pass gas, vomiting, fever or unexplained weight loss. NIDDK advises assessment rather than another self-treatment trial in these circumstances.⁴