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 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IBSRELA (tenapanor hydrochloride) is an oral tablet approved in September 2019 for irritable bowel syndrome with constipation (IBS-C) in adults. It works by inhibiting the sodium/hydrogen exchanger 3 (NHE3) on the intestinal epithelium, reducing sodium absorption and increasing water secretion into the intestinal lumen. This mechanism accelerates intestinal transit, softens stool consistency, and reduces visceral hypersensitivity and abdominal pain. IBSRELA represents a novel mechanism class in the IBS-C treatment landscape, offering a targeted approach distinct from traditional osmotic or secretory laxatives.
$0.0BPart D
16.6 years to LOEMechanism 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.