Tenapanor

Generic Name: Tenapanor

Brand Names: Ibsrela

Drug Type: Small Molecule

Chemical Formula: C_₅₀H_₆₆Cl_₄N_₈O_₁₀S_₂

CAS Number: 1234423-95-0

Unique Ingredient Identifier: WYD79216A6

Background: 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

Assessing Tenapanor as a Treatment of CF-related Constipation.

Phase 3

Not yet recruiting

Conditions: Cystic Fibrosis
Constipation

Interventions: Drug: Tenapanor

First Posted Date: 2025-02-05

Last Posted Date: 2025-05-09

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 25

Registration Number: NCT06810167

4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs

Phase 2

Recruiting

Conditions: Irritable Bowel Syndrome with Constipation (IBS-C)

Interventions: Drug: Tenapanor
Drug: Placebo

First Posted Date: 2024-08-14

Last Posted Date: 2025-01-17

Lead Sponsor: Ardelyx

Target Recruit Count: 72

Registration Number: NCT06553547

Locations: 🇺🇸
Texas Digestive Specialists, Harlingen, Texas, United States
🇺🇸
Florida Pharmaceutical Research and Associates, Inc., South Miami, Florida, United States

A Novel Approach for Reducing Hyperoxaluria and Kidney Stone Risk.

Phase 4

Recruiting

Conditions: Hyperoxaluria

Interventions: Drug: Tenapanor
Other: Placebo

First Posted Date: 2024-07-01

Last Posted Date: 2025-05-13

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 10

Registration Number: NCT06481150

Locations: 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

Tenapanor in Synucleinopathy-Related Constipation

Phase 2

Recruiting

Conditions: Synucleinopathy
Parkinson's Disease

Interventions: Drug: Tenapanor
Drug: Placebo

First Posted Date: 2024-06-14

Last Posted Date: 2025-02-10

Lead Sponsor: Cedar Valley Digestive Health Center

Target Recruit Count: 30

Registration Number: NCT06460038

Locations: 🇺🇸
Cedar Valley Digestive Health Center, Waterloo, Iowa, United States

An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

Phase 1

Completed

Conditions: Lactation

Interventions: Drug: Tenapanor

First Posted Date: 2024-01-12

Last Posted Date: 2024-07-11

Lead Sponsor: Ardelyx

Target Recruit Count: 7

Registration Number: NCT06203444

Locations: 🇺🇸
Fortrea Clinical Research Unit, Madison, Wisconsin, United States
🇺🇸
DDSI, Oklahoma City, Oklahoma, United States

Effect of Tenapanor on the Metagenomics and Metabolomics of Patients With Irritable Bowel Syndrome With Constipation

Phase 4

Recruiting

Conditions: IBS
IBS - Irritable Bowel Syndrome

Interventions: Drug: Tenapanor

First Posted Date: 2023-08-16

Last Posted Date: 2024-02-08

Lead Sponsor: Kyle Staller, MD, MPH

Target Recruit Count: 30

Registration Number: NCT05995899

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C

Phase 3

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions: Drug: Tenapanor

First Posted Date: 2023-06-15

Last Posted Date: 2024-12-13

Lead Sponsor: Ardelyx

Target Recruit Count: 150

Registration Number: NCT05905926

Locations: 🇺🇸
Advantage Clinical Trials, Bronx, New York, United States
🇺🇸
Frontier Clinical Research, Kingwood, West Virginia, United States
🇺🇸
G & L Research, LLC, Foley, Alabama, United States

and more 14 locations

Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years

Phase 3

Recruiting

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions: Drug: Tenapanor 25 mg bid
Drug: Placebo
Drug: Tenapanor 50 MG

First Posted Date: 2022-12-08

Last Posted Date: 2024-12-17

Lead Sponsor: Ardelyx

Target Recruit Count: 180

Registration Number: NCT05643534

Locations: 🇺🇸
Proactive Clinical Research, El Paso, Texas, United States
🇺🇸
G & L Research, LLC, Foley, Alabama, United States
🇺🇸
Eclipse Clinical Research, Tucson, Arizona, United States

and more 29 locations