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Tenapanor

Generic Name
Tenapanor
Brand Names
Ibsrela
Drug Type
Small Molecule
Chemical Formula
C50H66Cl4N8O10S2
CAS Number
1234423-95-0
Unique Ingredient Identifier
WYD79216A6

Overview

Tenapanor is a novel, small molecule medication approved in September 2019 for the treatment of constipation-predominant irritable bowel-syndrome (IBS-C). It was first designed and synthesized in 2012. As an inhibitor of the sodium/hydrogen exchanger isoform 3 (NHE3) transporter, it is the first and currently only medication within its class and therefore exists as a novel alternative in the treatment of IBS-C. In October 2023, tenapanor was approved for the treatment of chronic kidney disease.

Indication

Tenapanor is indicated for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) in adults. It is also indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Associated Conditions

  • Chronic Kidney Disease (CKD)
  • Irritable Bowel Syndrome With Constipation (IBS-C)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
Assessing Tenapanor as a Treatment of CF-related Constipation.
2025/02/05
NCT06810167
Phase 3
Recruiting
Massachusetts General Hospital
4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs
2024/08/14
NCT06553547
Phase 2
Recruiting
Ardelyx
A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.
2024/07/01
NCT06481150
Phase 4
Recruiting
University of Texas Southwestern Medical Center
Tenapanor in Synucleinopathy-Related Constipation
2024/06/14
NCT06460038
Phase 2
Recruiting
Cedar Valley Digestive Health Center
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
2024/01/12
NCT06203444
Phase 1
Completed
Ardelyx
Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation
2023/08/16
NCT05995899
Phase 4
Recruiting
Kyle Staller, MD, MPH
Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
2023/06/15
NCT05905926
Phase 3
ENROLLING_BY_INVITATION
Ardelyx
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
2022/12/08
NCT05643534
Phase 3
Recruiting
Ardelyx
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
2020/09/16
NCT04549597
Phase 4
Completed
Ardelyx
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
2019/06/18
NCT03988920
Phase 4
Completed
Ardelyx

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
XPHOZAH 30 mg
Ardelyx, Inc.
73154-130
ORAL
31.9 mg in 1 1
10/17/2023
XPHOZAH 20 mg
Ardelyx, Inc.
73154-120
ORAL
21.3 mg in 1 1
10/17/2023
XPHOZAH 10 mg
Ardelyx, Inc.
73154-110
ORAL
10.6 mg in 1 1
10/17/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
IBSRELA TABLETS 50MG
N/A
FOSUN INDUSTRIAL CO., LIMITED
N/A
N/A
11/3/2023

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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