Tenapanor completes Phase 3 IBS-C trial in adolescents

A Phase 3 study of tenapanor for adolescents with irritable bowel syndrome with constipation (IBS-C) reached its primary completion date on 20 August 2026, according to the ClinicalTrials.gov record. The trial enrolled 180 participants aged 12 to under 18; the registry lists the study as completed but provides no outcome measurements or results.

Background

The study assessed tenapanor in pediatric patients with IBS-C. The supplied record identifies tenapanor as the study drug and IBS-C as the condition, but does not describe the drug’s mechanism, prior approvals, or the prevalence of IBS-C. It also does not report whether the study’s findings support use in this age group.

Trial design

This randomized, double-blind, placebo-controlled Phase 3 study, identified as NCT05643534, enrolled 180 participants with IBS-C who were at least 12 and under 18 years old. Participants were assigned to study arms involving tenapanor 25 mg twice daily, tenapanor 50 mg, or placebo. The registry summary describes treatment over 12 consecutive weeks and says the study assessed efficacy, safety, and tolerability. The supplied record does not list primary-outcome entries.

What this means

Completion marks a study milestone, not a report of whether tenapanor improved IBS-C symptoms or how its safety compared with placebo. The record supplied for this article includes no efficacy measurements, statistical analyses, or adverse-event summary, so it does not support conclusions about benefit or risk in adolescents. Although the trial is listed as completed, the available information does not show its results or indicate when results will be posted. Clinicians, patients, and advocates seeking evidence of treatment effects should distinguish this completion notice from a results announcement.

Source

Source: ClinicalTrials.gov, study registry record for “Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years,” with a primary completion date of 20 August 2026. Available at clinicaltrials.gov/study/NCT05643534.