Tenapanor for chronic constipation (ACCEL)

Resolution Criteria Trial: NCT07382167 Selected endpoint key: 8c0d9f9853e231b5ac80ac6b19ced13fee35fabb15fb59b06f7bf5f13d06a26f Selected endpoint: Durable complete spontaneous bowel movements (CSBM) response Endpoint type: other Protocol outcome group: primary Endpoint description: Durable complete spontaneous bowel movements (CSBM) response is defined as achieving the weekly CSBM response for ≥9 out of the first 12 weeks of the randomized treatment period and and for ≥3 of the last 4 weeks of the first 12 weeks of randomized treatment period Endpoint timeframe: 12 Weeks ClinicalTrials.gov population: Randomized adults with chronic idiopathic constipation. Market population: Randomized adults with chronic idiopathic constipation. Analysis set: Prespecified primary efficacy analysis set; the public registry does not name the analysis set. Comparison: Prespecified primary comparison(s) of the randomized tenapanor 5 mg BID, 25 mg BID, and 50 mg BID arms versus matching placebo. Success direction: higher Success rule: A qualifying positive readout requires the prespecified tenapanor-versus-placebo primary comparison to show a higher durable complete spontaneous bowel movement responder rate at 12 weeks and meet the prespecified statistical success criterion. Durable response requires weekly CSBM response during at least 9 of the first 12 randomized-treatment weeks, including at least 3 of the final 4 weeks. A weekly CSBM response requires both an increase of at least 1 from baseline in average weekly CSBM frequency and an average weekly CSBM frequency of at least 3 during that week. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT07382167?tab=researcher#outcome-measures:~:text=Durable%20complete%20spontaneous%20bowel%20movements%20(CSBM)%20response YES 1. The exact selected endpoint (Durable complete spontaneous bowel movements (CSBM) response) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Durable complete spontaneous bowel movements (CSBM) response) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2027-12-31 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2027-12-31T23:59:59Z Deadline evidence: AI bounded approximation (confidence 95/100): official source supports 2027-07-01 through 2027-12-31; market deadline 2027-12-31 is the conservative end of that window. Ardelyx's Form 10-Q filed August 6, 2026 states that the company expects to announce ACCEL topline data in the second half of 2027. Because the official evidence provides a half-year window rather than an exact day, the conservative market deadline is the final calendar day of that window. The ClinicalTrials.gov primary-completion date is not used as the disclosure deadline. Deadline evidence source: https://www.sec.gov/Archives/edgar/data/1437402/000143740226000044/ardx-20260630.htm Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.