Last reviewed · How we verify
TENAPANOR HYDROCHLORIDE
At a glance
| Generic name | TENAPANOR HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2019 |
Approved indications
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
- Flatulence
- Dizziness
- Rectal Bleeding
- Abnormal Gastrointestinal Sounds
- Pruritis
- Rash
- Urticaria
Serious adverse events
- Severe Diarrhea
- Hyperkalemia
Key clinical trials
- D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects (PHASE1)
- A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations (PHASE1)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TENAPANOR HYDROCHLORIDE CI brief — competitive landscape report
- TENAPANOR HYDROCHLORIDE updates RSS · CI watch RSS