New drug aims to ease chronic constipation in large trial

NCT ID NCT07382167

Symptom relief Sponsor: Ardelyx Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests three doses of tenapanor (5, 25, or 50 mg twice daily) against a placebo in 692 adults with chronic idiopathic constipation. Over 26 weeks, researchers will check if the drug increases complete spontaneous bowel movements. The goal is to find a safe, effective option for people with this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tenapanor
What this could lead to: If it works, this could provide a new daily medication option for people with chronic constipation who haven't found relief.
What could go wrong: This is a Phase 3 trial, but the drug may not work better than placebo, or side effects could limit its use. Results are not yet known.

Why investors are watching

Ardelyx is running a Phase 3 trial of tenapanor, a drug for chronic idiopathic constipation, in 692 adults over 26 weeks. For a small company like Ardelyx, this readout is a major event because the drug's approval and commercial future likely hinge on these results.

If it works: If the trial shows tenapanor is safe and effective, Ardelyx could gain a new approved treatment for a common condition, which would give the company a product to sell and a reason to grow.

If it fails: If the trial fails or shows safety problems, Ardelyx may have to abandon the drug, which would be a serious setback for a company of this size. Trials often fail, so a negative result is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 692 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients ≥18 to ≤80 years old at the Screening visit (Visit 1). 2. Meet the Rome IV Diagnostic Criteria for functional constipation. 3. Females of non-childbearing potential, or agree to the use of an acceptable means of contraception for up to 30 days following the last dose of study medication. 4. Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization. 5. Meets the entry criteria assessed during the Screening period. 6. Ability to understand and provide input on the assessments in the eDiary. 7. Provide written informed consent before the initiation of any study-specific procedures. 8. Must agree to have daily access to eDiary via a computer, tablet or smart phone Exclusion Criteria: 1. Loose or watery stool in the absence of any medication that is known to affect stool consistency for \>25% of bowel movements (BMs) during the 3 months prior to the Screening visit 2. Fecal impaction within 6 months prior to the Screening visit 3. Unexplained and clinically significant alarm symptoms. 4. Functional diarrhea as defined by Rome IV criteria 5. IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria 6. Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit 7. Patient with central nervous system disorder 8. Use of prohibited medications defined by protocol 9. Patient has a history or current evidence of laxative abuse 10. Hepatic dysfunction 11. Positive HIV, hepatitis B or hepatitis C test at screening 12. Positive urinary drug test at Screening, with the exception of cannabis and cannabidiol (CBD) 13. Any evidence of or treatment of malignancy within 1 year prior to the Screening visit 14. Any surgery on the stomach, small intestine or colon; appendectomy or cholecystectomy are not excluded unless within 60 days prior to the Screening visit 15. Pregnant women or women planning to become pregnant during trial participation 16. A major psychiatric disorder that has required hospitalization in the last year prior to the Screening visit. 17. Alcohol or substance abuse within 1 year prior to the Screening visit 18. Participation in other clinical trials within 1 month prior to the Screening visit 19. Clinical evidence of significant disease that may interfere with the patient's successful completion of the trial

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Conditions

The condition(s) this trial relates to.

constipation disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic idiopathic constipation (CIC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

109 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

310 Clinical Research
RECRUITING

Inglewood, California, 90301, United States
3A Research
RECRUITING

El Paso, Texas, 79925, United States
Accellacare of Bristol
RECRUITING

Bristol, Tennessee, 37620, United States
Accellacare of Cary
RECRUITING

Cary, North Carolina, 27518, United States
Accellacare of Knoxville
RECRUITING

Knoxville, Tennessee, 37938, United States
Accellacare of Piedmont HealthCare
RECRUITING

Statesville, North Carolina, 28625, United States
Accellacare of Raleigh
RECRUITING

Raleigh, North Carolina, 27609, United States
Accellacare of Rocky Mount
RECRUITING

Rocky Mount, North Carolina, 27804, United States
Accellacare of Salisbury
RECRUITING

Salisbury, North Carolina, 28144, United States
Accellacare of Winston-Salem, Triad Neurological Associates
RECRUITING

Winston-Salem, North Carolina, 27103, United States
Acclaim Clinical Research
RECRUITING

San Diego, California, 92120, United States
Advanced Research Institute - Denver
RECRUITING

Denver, Colorado, 80218, United States
Advanced Research Institute - Ogden
RECRUITING

Ogden, Utah, 84405, United States
Advanced Research Institute - Portland
RECRUITING

Tigard, Oregon, 97223, United States
Advanced Research Institute - Reno
RECRUITING

Reno, Nevada, 89511, United States
Advanced Research Institute - Sandy
RECRUITING

Sandy City, Utah, 84092, United States
Agile Clinical Research Trials, LLC
RECRUITING

Atlanta, Georgia, 30328, United States
Albuquerque Clinical Trials (ACT)
RECRUITING

Albuquerque, New Mexico, 87102, United States
Allied Digestive Health - Jersey Shore Gastroenterology - Point Commons
RECRUITING

Somers Point, New Jersey, 08244, United States
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
RECRUITING

Jackson, New Jersey, 08724, United States
Arizona Liver Health - Chandler
RECRUITING

Chandler, Arizona, 85225, United States
Arkansas Gastroenterology - North Little Rock
RECRUITING

North Little Rock, Arkansas, 72117, United States
Bay State Clinical Trials
RECRUITING

Watertown, Massachusetts, 02472, United States
Centricity Research Columbus Ohio Multispecialty
RECRUITING

Columbus, Ohio, 43213, United States
Charlottesville Medical Research Center, LLC
RECRUITING

Charlottesville, Virginia, 22911, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Clinical Investigation Specialists, Inc
RECRUITING

Gurnee, Illinois, 60031, United States
Clinical Neuroscience Solutions, Inc - Memphis
RECRUITING

Memphis, Tennessee, 38119, United States
Clinical Research Center of Florida
RECRUITING

Pompano Beach, Florida, 33060, United States
Clinical Research Institute of Arizona, LLC
RECRUITING

Sun City West, Arizona, 85375, United States
Clinical Trials Research
RECRUITING

Lincoln, California, 95648, United States
Coastal Carolina Research Center
RECRUITING

North Charleston, South Carolina, 29405, United States
Coastal Research Institute, LLC
RECRUITING

Fayetteville, North Carolina, 28304, United States
Del Sol Research Management, LLC
RECRUITING

Tucson, Arizona, 85715, United States
DelRicht Clinical Research - Atlanta
RECRUITING

Atlanta, Georgia, 30329, United States
DelRicht Clinical Research - Charleston
RECRUITING

Charleston, South Carolina, 29407, United States
DelRicht Clinical Research - Covington
RECRUITING

Mandeville, Louisiana, 70471, United States
DelRicht Clinical Research - Gulfport
RECRUITING

Gulfport, Mississippi, 39503, United States
DelRicht Clinical Research - Indianapolis
RECRUITING

Indianapolis, Indiana, 46202, United States
DelRicht Clinical Research - Louisville
RECRUITING

Louisville, Kentucky, 40205, United States
DelRicht Clinical Research - McKinney
RECRUITING

Prosper, Texas, 75078, United States
DelRicht Clinical Research - Nashville
RECRUITING

Hendersonville, Tennessee, 37075, United States
DelRicht Clinical Research - New Orleans
RECRUITING

New Orleans, Louisiana, 70115, United States
DelRicht Clinical Research - Overland Park
RECRUITING

Overland Park, Kansas, 66209, United States
DelRicht Clinical Research - Prairieville
RECRUITING

Prairieville, Louisiana, 70769, United States
DelRicht Clinical Research - Springfield
RECRUITING

Springfield, Missouri, 65807, United States
DelRicht Clinical Research - Town and Country
RECRUITING

Town and Country, Missouri, 63017, United States
DelRicht Clinical Research - Tulsa
RECRUITING

Tulsa, Oklahoma, 74133, United States
DelRicht Clinical Research - Vienn
RECRUITING

Vienna, Virginia, 22182, United States
Delricht Clinical Research - Badmus
RECRUITING

Charlotte, North Carolina, 28210, United States
Delta Research Partners of West Monroe, LLC
RECRUITING

West Monroe, Louisiana, 71291, United States
Digestive Disease Specialists
RECRUITING

Las Vegas, Nevada, 89128, United States
Drug Trials America
RECRUITING

Hartsdale, New York, 10530, United States
EPIC Medical Research
RECRUITING

DeSoto, Texas, 75115, United States
Elite Clinical Studies
RECRUITING

Phoenix, Arizona, 85018, United States
Elite Clinical Trials-Idaho
RECRUITING

Blackfoot, Idaho, 83221, United States
Elixia SISU BHR - Sprinfield
RECRUITING

Springfield, Massachusetts, 01103, United States
Erick H. Alayo Medical Corporation
RECRUITING

Chula Vista, California, 91910, United States
Evanston Premier Healthcare Research LLC
RECRUITING

Skokie, Illinois, 60077, United States
Excel Clinical Research
RECRUITING

Las Vegas, Nevada, 89109, United States
G & L Research, LLC
RECRUITING

Foley, Alabama, 36535, United States

Contact Email: •••••@•••••
GI Alliance - Glenview, IL
RECRUITING

Glenview, Illinois, 60026, United States
GW Research Inc.
RECRUITING

Chula Vista, California, 91010, United States
Gastrointestinal Associates LLP
RECRUITING

Columbia Falls, Montana, 65201, United States
Gastrointestinal Specialists of Georgia PC
RECRUITING

Marietta, Georgia, 30060, United States
Great Lakes Gastroenterology Research
RECRUITING

Mentor, Ohio, 44060, United States
Harmony Clinical Research - Orlando
RECRUITING

Orange City, Florida, 32763, United States
Harmony Clinical Research, Inc - North Miami Beach
RECRUITING

Miami Beach, Florida, 33162, United States
Health Research of Hampton Roads, Inc. - Newport News
RECRUITING

Newport News, Virginia, 23606, United States
Hometown Urgent Care and Research - Huber Heights
RECRUITING

Huber Heights, Ohio, 45424, United States
Hope Clinical Research - Canoga Park
RECRUITING

Canoga Park, California, 91303, United States
IMIC, Inc
RECRUITING

Miami, Florida, 33176, United States
Jubilee Clinical Research, Inc.
RECRUITING

Las Vegas, Nevada, 89106, United States
Kansas City Research Institute
RECRUITING

Kansas City, Missouri, 64131, United States
Lillestol Research, LLC
RECRUITING

Fargo, North Dakota, 58104, United States
LinQ Research, LLC
RECRUITING

Pearland, Texas, 77584, United States
Lucas Research - Diabetes & Endocrinology Consultants, PC
RECRUITING

Morehead City, North Carolina, 28557, United States
NY Scientific
RECRUITING

Brooklyn, New York, 11235, United States
New Phase Research & Development - Knoxville
RECRUITING

Knoxville, Tennessee, 37909, United States
North Georgia Clinical Research
RECRUITING

Woodstock, Georgia, 30189, United States
North Hills Medical Research Inc. (North Hills Family Medicine)
RECRUITING

North Richland Hills, Texas, 76180, United States
Om Research LLC
RECRUITING

Lancaster, California, 93534, United States
Paragon Rx Clinical, Inc. - Santa Ana
RECRUITING

Santa Ana, California, 92703, United States
Peters Medical Research
RECRUITING

High Point, North Carolina, 27260, United States
Proactive Clinical Research
RECRUITING

Fort Lauderdale, Florida, 33308, United States
Quality Medical Research, PLLC
RECRUITING

Nashville, Tennessee, 37211, United States
Remington Davis, Inc.
RECRUITING

Columbus, Ohio, 43215, United States
Rocky Mountain Gastroenterology (RMG) - Littleton
RECRUITING

Lakewood, Colorado, 80228, United States
San Jose Gastroenterology
RECRUITING

San Jose, California, 95128, United States
Sensible Healthcare, LLC
RECRUITING

Ocoee, Florida, 34761, United States
Southwest Gastroenterology
RECRUITING

Oak Lawn, Illinois, 60453, United States
St. Charles Clinical Research
RECRUITING

St Louis, Missouri, 63141, United States
Sun Research Institute
RECRUITING

San Antonio, Texas, 78215, United States
Suncoast Clinical Research, Inc. - New Port Richey
RECRUITING

New Port Richey, Florida, 34652, United States
Suncoast Clinical Research, Inc. - Palm Harbor
RECRUITING

Palm Harbor, Florida, 34684, United States
Tandem Clinical Research
RECRUITING

Marrero, Louisiana, 70072, United States
Tandem Clinical Research GI - Houma
RECRUITING

Houma, Louisiana, 70363, United States
Tekton Research - Longmont, CO
RECRUITING

Longmont, Colorado, 80501, United States
Tekton Research - Wichita, KS
RECRUITING

Wichita, Kansas, 67218, United States
Tekton Research - Yukon, OK
RECRUITING

Yukon, Oklahoma, 73099, United States
Texas Gastro Consultants
RECRUITING

Tomball, Texas, 77375, United States
The Center for Clinical Trials
RECRUITING

Saraland, Alabama, 36571, United States
Treasure Valley Medical Research
RECRUITING

Boise, Idaho, 83706, United States
University of Michigan Health System
RECRUITING

Ann Arbor, Michigan, 48109, United States
Valencia Medical and Research Center
RECRUITING

Miami, Florida, 33174, United States
Wasatch Clinical Research, LLC
RECRUITING

Salt Lake City, Utah, 84107, United States
Waterway Research
RECRUITING

Miami, Florida, 33155, United States
Woodholme Gastroenterology
RECRUITING

Glen Burnie, Maryland, 21061, United States
Zenos Clinical Research
RECRUITING

Dallas, Texas, 75230, United States

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