tenapanor
tenapanor: sourced relationships with 1 company · 5 clinical trials tracked · 1 FDA decision.
tenapanor evidence translation
What we can confirm
1 FDA record · 5 tracked trials
What it means
What to watch
Prepared research question
How could tenapanor → ARDX affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| ARDELYX, INC. (ARDX) Reduce serum phosphorus in adults with chronic kidney diseas… | Approved |
| ARDELYX, INC. (ARDX) Irritable Bowel Syndrome With Constipation (IBS-C) | Phase 3 |
Clinical Trial Registry Records (5)
An Open-label, Single Center Study Assessing Tenapanor as a Non-CFTR-mediated Treatment of CF-related Constipation in People With CF.
Primary endpoint: Increase in SBM frequency
4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old
Primary endpoint: Average weekly SBM (week 4)
An Open-label, Single Center Investigator Sponsored Study Assessing the Effect of Tenapanor on Metagenomic and Metabolomic Markers in Patients With Irritable Bowel Syndrome With Constipation
Primary endpoint: Measuring metagenomics of stool samples using whole genome shotgun sequencing (WGS)
An Open-Label Long-Term Safety Study of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 6 to Less Than 18 Years Old
Primary endpoint: Safety Measure Assessment (Adverse Event)
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Irritable Bowel Syndrome With Constipation (IBS-C) in Pediatric Patients 12 to Less Than 18 Years Old
Primary endpoint: 6/12-week APS (abdominal pain and SBM) +2 response
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with tenapanor?
tenapanor has dated SEC/FDA relationship records for ARDELYX, INC..
How many clinical trials involve tenapanor?
BioSniper tracks 5 clinical trials involving tenapanor.
What is tenapanor's latest FDA decision?
The most recent tracked FDA decision for tenapanor is Approval, dated October 17, 2023.