Elobixibat may Boost Bowel Movement Frequency, Suggests Study

With chronic constipation affecting nearly 25% of the Indian population, there is a critical clinical need for therapies that avoid the resistance and habituation typical of traditional stimulant laxatives. To address this gap, Dr. Piyush Agarwal and researchers from Dr. Reddy’s Laboratories evaluated the efficacy and safety of elobixibat, a novel once-daily ileal bile acid transporter (IBAT) inhibitor, specifically within the Indian patient population.

Therefore, in the prospective, 16-site, phase III randomized trial, 150 Indian adults with functional constipation for at least six months received either 10 mg elobixibat or placebo daily for two weeks. To isolate functional outcomes, the study excluded organic gastrointestinal (GI) disorders and prior major surgeries. The primary endpoint was the change in weekly spontaneous bowel movement (SBM) frequency, while secondary measures included complete responder (CSBM) rates and median time to the first bowel movement.

Key Clinical Findings of the Study Includes:

• Superior Primary Efficacy: The study demonstrated that elobixibat treatment resulted in a statistically significant least square mean increase in weekly spontaneous bowel movements of 3.83 compared to 2.68 in the placebo group (p = 0.008).

• Doubled Responder Rates: Nearly half of the active treatment group (49.33%) achieved a complete spontaneous bowel movement response—defined as having three or more movements per week with an increase of at least one from baseline—compared to only 26.76% of placebo recipients (p = 0.005).

• Rapid Onset of Action: Clinical data showed a meaningful acceleration in relief, with the median time to the first spontaneous bowel movement being approximately 11.5 hours for the elobixibat group, nearly half the 22.5 hours observed in the placebo arm.

• Consistent Tolerability Profile: The study confirmed a favorable safety profile with most adverse events being mild, most notably abdominal pain at 7.89%, while recording zero deaths or serious adverse events during the intervention.

• Mechanism-Driven Improvement: Elobixibat successfully utilized its unique mechanism of blocking the enterohepatic circulation of bile acids to enhance colonic transit and stimulate intestinal secretion.

The results suggest that elobixibat is a highly effective and well-tolerated short-term treatment for Indian patients, evidenced by a statistically significant 22.57% difference in complete spontaneous bowel movement response rates over placebo

Thus, the study concludes that the novel ileal bile acid transporter inhibitor provides clinicians with a powerful and convenient once-daily oral option that expands the current therapeutic armamentarium for managing difficult-to-treat functional constipation.

While limitations such as potential patient recall bias and a high placebo response likely caused by prior bowel preparation were noted, the study highlights the necessity for further exploration into the long-term clinical utility of this therapeutic class within diverse patient demographics.

Reference

Agarwal P, Jha BK, Somagoni J, et al. Efficacy and safety of elobixibat in patients with chronic constipation—A randomized, multicenter, double-blind, placebo-controlled, parallel-group study from India. Indian J Gastroenterol. 2025;44(3):336–344