Last reviewed 2026-04-20 · How we verify

Ibsrela (AZD1722)

Ibsrela works by inhibiting the sodium/hydrogen exchanger 3, a protein that regulates the balance of sodium and hydrogen ions in the gut.

At a glance

Mechanism of action

Tenapanor is locally acting inhibitor of the sodium/hydrogen exchanger (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 surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in softer stool consistency.Tenapanor has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability.

Approved indications

• Irritable bowel syndrome characterized by constipation

Boxed warnings

• WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration [see Contraindications (4) , Use in Specific Populations (8.4) ]. Avoid use of IBSRELA in patients 6 years to less than 12 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ]. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age [see Use in Specific Populations (8.4) ] . WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. IBSRELA is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. ( 4 , 8.4 ) Avoid use of IBSRELA in patients 6 years to less than 12 years of age. ( 5.1 , 8.4 ) The safety and effectiveness of IBSRELA have not been established in pediatric patients less than 18 years of age. ( 8.4 )

Common side effects

• Diarrhea
• Abdominal Distension
• Severe Diarrhea
• Dizziness
• Flatulence
• Rectal Bleeding
• Abnormal Gastrointestinal Sounds
• Hyperkalemia

Key clinical trials

• Assessing Tenapanor as a Treatment of CF-related Constipation. (PHASE3)
• A 26-Wk Study to Assess Safety & Efficacy of Tenapanor for T/t of Chronic Idiopathic Constipation in Adults (PHASE3)
• Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation (PHASE4)
• A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk. (PHASE4)
• 4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs (PHASE2)
• Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years (PHASE3)
• Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C (PHASE3)
• Tenapanor in Synucleinopathy-Related Constipation (PHASE2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Ibsrela CI brief — competitive landscape report
• Ibsrela updates RSS · CI watch RSS
• Ardelyx Inc portfolio CI