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TENAPANOR
Tenapanor is a marketed drug primarily indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C). Its key strength lies in its unique mechanism of action, which differentiates it from existing treatments. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | TENAPANOR |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2019 |
Approved indications
- Irritable Bowel Syndrome with Constipation (IBS-C)
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
Drug interactions
- enalapril
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
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TENAPANOR CI brief — competitive landscape report
- TENAPANOR updates RSS · CI watch RSS