Tenapanor Reaches Primary Completion in Phase 3 CF Trial

ClinicalTrials.gov recorded primary completion on June 15, 2026 for a Phase 3 study evaluating tenapanor in people with cystic fibrosis-related constipation. The trial enrolled 25 participants and was listed as active, not recruiting; the supplied registry data do not report outcome measurements or study results.

Background

Tenapanor is described in the registry as the newest FDA-approved drug for irritable bowel syndrome with constipation, or IBS-C. This study examined its use for constipation related to cystic fibrosis, a different patient population and condition. The trial’s listed conditions were cystic fibrosis and constipation.

Trial design

This was a Phase 3 study with 25 participants. The registered intervention was tenapanor, with no comparator intervention listed in the supplied data. Participants were to take one 50 mg tablet twice daily during a 4-week treatment period.

The study planned to assess gastrointestinal symptom burden and spontaneous bowel movement frequency. Participants were also scheduled to complete the Patient Assessment of Constipation Symptoms questionnaire, the Patient Assessment of Constipation Quality of Life questionnaire, and the Irritable Bowel Syndrome Symptom Severity Scale, along with daily diaries.

What this means

Primary completion marks the point at which the trial’s primary data collection was expected to be completed, but the supplied record does not provide a primary endpoint result, statistical analysis, efficacy measurement, or adverse-event summary. The available information therefore describes the study’s purpose and design rather than showing whether tenapanor improved constipation related to cystic fibrosis.

The trial was listed as active, not recruiting, and its completion status does not establish a new approval or indication for tenapanor. Any interpretation of benefit or risk will require the registry’s future results or another primary source reporting the study findings.

Source

Source: ClinicalTrials.gov, trial record for NCT06810167, documenting the Phase 3 study’s primary completion on June 15, 2026. The registry record is available at clinicaltrials.gov/study/NCT06810167.