ArticleDigestive diseases and sciences2026
Efficacy of Tenapanor in Patients With or Without Prior Use of IBS-C Prescription Medications: A Post-hoc Analysis of Phase 3 Clinical Trials.
Article in Digestive diseases and sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundTenapanor is approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. The impact of prior IBS-C prescription treatment(s) on the therapeutic efficacy of tenapanor is unknown.
aimsTo assess whether prior IBS-C prescription medication use affected clinical response to tenapanor in pooled data from the phase 3 T3MPO-1 and T3MPO-2 trials.
methodsAdults with IBS-C were randomized to twice-daily tenapanor or placebo for 12 (T3MPO-1) or 26 (T3MPO-2) weeks. Patients discontinued use of prior IBS-C prescription medications, which were prohibited per protocol, during screening. Post-hoc analyses evaluated responder rates over the first 12 weeks in patients with and without prior IBS-C prescription medication use. The primary composite responder endpoint was defined as achieving ≥ 1 increase in weekly complete spontaneous bowel movements and ≥ 30% reduction in average weekly abdominal pain score from baseline in the same week for ≥ 6 of 12 weeks.
resultsThe pooled intent-to-treat population comprised 600 tenapanor-treated patients, of whom 26 (4.3%) reported prior IBS-C prescription medication use (linaclotide, n = 16; lubiprostone, n = 10), and 599 placebo-treated patients. Among patients with prior IBS-C prescription medication use, composite responder rates were 42.3% (11/26) for tenapanor and 18.8% (6/32) for placebo (p = 0.038). Among patients without prior IBS-C prescription medication use, composite responder rates were 31.2% (179/574) for tenapanor and 21.3% (121/567) for placebo (p < 0.001).
conclusionsA clinically meaningful response to tenapanor was observed in adults with IBS-C regardless of prior IBS-C prescription medication use.
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