Postmarketing surveillance of elobixibat for patients with chronic constipation and concomitant schizophrenia or depression in Japan - Report - MDSpire

Postmarketing surveillance of elobixibat for patients with chronic constipation and concomitant schizophrenia or depression in Japan

  • By

  • Yoshiteru Takekita

  • Minami Umeyama

  • Mie Iwaida

  • Masaaki Higashikawa

  • Yusuke Shimada

  • Atsushi Nakajima

  • April 20, 2026

  • 0 min

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Clinical Report: Postmarketing Evaluation of Elobixibat in Japanese Patients

Overview

This study evaluates the safety and effectiveness of elobixibat in treating chronic constipation among Japanese patients with schizophrenia or depression. Results indicate significant improvements in defecation frequency and stool consistency without serious adverse drug reactions.

Background

Chronic constipation is a prevalent gastrointestinal disorder that significantly impacts the quality of life, particularly in patients with psychiatric conditions such as schizophrenia and depression. These patients often experience constipation due to the side effects of medications, making effective treatment essential. Elobixibat, a novel laxative, offers a potential therapeutic option by targeting the underlying mechanisms of constipation.

Data Highlights

GroupBaseline Defecation FrequencyWeek 4 Defecation FrequencyWeek 52 Defecation FrequencyADRs (%)
Schizophrenia (4-week)3.35.3N/A4.76
Depression (4-week)3.04.9N/A3.88
Schizophrenia (52-week)N/AN/AHigher than baseline2.33
Depression (52-week)N/AN/AHigher than baseline9.09

Key Findings

  • Elobixibat improved defecation frequency significantly in both schizophrenia and depression groups.
  • Mean defecation frequency increased from 3.3 to 5.3 in schizophrenia patients and from 3.0 to 4.9 in depression patients after 4 weeks.
  • Approximately 60% of patients achieved an ideal Bristol Stool Form Scale score of 4 by week 52.
  • Adverse drug reactions were low, with diarrhea being the most common, affecting 4.76% of schizophrenia patients and 3.88% of depression patients in the 4-week group.
  • No serious adverse drug reactions were reported during the study period.

Clinical Implications

The findings suggest that elobixibat is a safe and effective treatment option for chronic constipation in patients with schizophrenia or depression. Clinicians should consider this medication for patients experiencing constipation related to psychiatric conditions, particularly given its favorable safety profile.

Conclusion

Elobixibat demonstrates significant efficacy in managing chronic constipation in patients with schizophrenia and depression, with a reassuring safety profile. These results support its use in clinical practice for this patient population.

References

  1. Author(s)/Org, Source, Year -- Title
  2. Journal of Gastroenterology — Establishing the Ideal Clinical Dose of Elobixibat, a New Ileal Bile Acid Transporter Inhibitor, for Japanese Patients with Chronic Constipation: Results from a Phase II Multicenter, Double-Blind, Placebo-Controlled Randomized Trial
  3. Journal of Gastroenterology — A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Polyethylene Glycol 3350 with Electrolytes for Chronic Constipation: Results from a 2-Week Study and a 52-Week Open-Label Follow-Up
  4. Drugs - Real World Outcomes — Long-Term Post-Marketing Evaluation of Fluvoxamine Maleate in Japanese Patients with Social Anxiety Disorder
  5. Journal of Gastroenterology — Assessment of the safety and effectiveness of crystalline lactulose (SK-1202) in Japanese individuals suffering from chronic constipation: a randomized, double-blind, placebo-controlled dose-ranging trial
  6. Establishing the Ideal Clinical Dose of Elobixibat
  7. A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Polyethylene Glycol 3350
  8. Long-Term Post-Marketing Evaluation of Fluvoxamine Maleate
  9. Assessment of the safety and effectiveness of crystalline lactulose

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