NDAORALTABLET
Approved
Sep 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
6/8 — Strong
IBSRELA (tenapanor hydrochloride) by Ardelyx is sodium/hydrogen exchanger 3 (nhe3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. Approved for irritable bowel syndrome with constipation (ibs-c) in adults. First approved in 2019.
Drug data last refreshed 6h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IBSRELA (tenapanor hydrochloride) is an oral small-molecule NHE3 inhibitor approved in 2019 for irritable bowel syndrome with constipation (IBS-C) in adults. It works by blocking sodium-hydrogen exchanger 3 on intestinal cells, increasing water secretion into the intestinal lumen to soften stool, accelerate transit, and reduce visceral pain and abdominal distension. The mechanism addresses both stool consistency and pain symptoms through reduced intestinal permeability and decreased neuronal hypersensitivity.
$0.034BPart D
Peak16.2 years to LOEProduct is in peak commercial stage with $34M in Part D spending (2023) and modest claim volume, indicating a stable niche franchise requiring focused team maintenance.
Mechanism of Action
sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. In vitro and animal studies indicate its major metabolite, M1, is not active against NHE3. By inhibiting NHE3 on the apical…
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.