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Tenapanor

Phase 3

Cystic Fibrosis | Small molecule | Respiratory |Ardelyx, Inc.|Last Updated: Mar 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
PRIORITY_REVIEW
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06810167Assessing Tenapanor as a Treatment of CF-related Constipation.PHASE3 RECRUITING 25Jun 1, 2025Jun 30, 2027Mar 18, 20261 United States
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Study Endpoints
Primary Endpoints
Increase in SBM frequency
Patients will record SBM frequency over the 4-week treatment period.

There will be a statistically significant increase in spontaneous bowel movement frequency (SBM) in cystic fibrosis patients with CF-related constipation receiving tenapanor.

Secondary Endpoints
Change in PAC-SYM questionnaire score
Patients will complete the PAC-SYM at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Change in PAC-QOL questionnaire score
Patients will complete the PAC-QOL at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
Change in IBS-SSS questionnaire score
Patients will complete the IBS-SSS at -2 weeks, 0 weeks, 2 weeks, and 4 weeks.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cystic fibrosis patients with CF-related constipationEXPERIMENTAL -
Interventions
NameTypeDescription
TenapanorDRUGCF patients with CFrC will ingest one 50 mg tablet of tenapanor twice daily for 4 weeks.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing) 2. Meeting criteria for CFrC Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months prior: * Straining in at least 25% of...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06810167studyFirstPostDate: changed