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New IBS drug candidate camlipixant enters Mid-Stage trial

NCT ID NCT07519395

Symptom relief Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This Phase 2b study tests camlipixant, an experimental drug, in 420 adults with moderate-to-severe irritable bowel syndrome (IBS) with diarrhea or mixed bowel habits. Participants receive either camlipixant or a placebo for 26 weeks. The main goal is to see if the drug reduces weekly abdominal pain. The trial also tracks other symptoms like bloating and discomfort.

What this could mean

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

Active substance
camlipixant
What this could lead to
If successful, camlipixant could offer a new treatment option to reduce abdominal pain and other symptoms in people with moderate-to-severe IBS-D and IBS-M.
What could go wrong
This is an early Phase 2b trial, so results may not confirm effectiveness. The drug may cause side effects, and not all participants may benefit. Larger studies are needed before it becomes available.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 420 people

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

Started

Apr 2026

Expected to finish

Jul 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: * Male or female aged 18 to 80 years inclusive, at the time of signing the Informed consent form (ICF). * Diagnosis of IBS-D or IBS-M according to the Rome IV criteria at screening * Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Scoring System (IBS SSS) at screening visit * Weekly API score \>=4.0 in each week of the run-in period * IBS-D: at least one stool with BSFS Type 6 or 7 consistency on at least 2 days in each week of the run-in period * IBS-M: an average of 2 days per week with abnormal bowel movements (BSFS Type 1, 2, 6, or 7) during the run-in period, and greater than (\>)25% of abnormal bowel movements must be Type 6 or 7 and \>25% Type 1 or 2 Exclusion Criteria: * Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U) * History or presence of inflammatory or immune-mediated Gastrointestinal (GI) disorders e.g. inflammatory bowel disease, microscopic colitis, or celiac disease * History or presence of GI infection (confirmed with stool culture) within 3 months prior to screening * History or presence of bile salt diarrhea * History of a primary psychiatric diagnosis that the Investigator considers may interfere with study assessments (e.g., schizophrenia, schizoaffective disorder, major depression, anxiety, panic attacks or bipolar disorder) OR Hospital Anxiety and Depression Scale (HADS) score of \>10 at screening. * Prior use of more than two of the following therapies or classes of therapy for the management of IBS: * Antidepressants or neuromodulators (e.g., Tricyclic antidepressant \[TCAs\], Selective serotonin reuptake inhibitor \[SSRIs\], gabapentinoids) * Antibiotics (e.g., rifaximin, neomycin) * 5-hydroxytryptamine 3 (5-HT3) receptor antagonists (e.g., alosetron, ramosetron, ondansetron) * Mu-opioid receptor agonists (e.g., eluxadoline) * Secretagogues (e.g., linaclotide, lubiprostone, plecanatide, tenapanor) * 5-hydroxytryptamine 4 (5-HT4) receptor agonists (e.g., tegaserod) * Abnormal thyroid function tests less than (\<) Lower limit of normal (LLN) or greater than (\>) upper limit of normal (ULN) confirmed at screening with Thyroid stimulating hormone (TSH) * Positive celiac serology * Elevated fecal calprotectin levels * QT interval corrected using Fridericia's formula (QTcF) \>450 millisecond (msec) or QTcF \>480 msec for participants with bundle branch block using the Fridericia's corrected QT interval. * Clinically significant abnormal laboratory tests at screening, after one repeat laboratory test if allowed by the Medical Monitor, including the following: * Alanine aminotransferase (ALT) \>2\*ULN * Total Bilirubin \>1.5\*ULN * Aspartate aminotransferase (AST) \>2\*ULN * Current or chronic history of liver disease (Child-Pugh class A, B, or C) or biliary abnormalities (with the exception of asymptomatic gallstones). Participants with known or suspected Gilbert's Syndrome are not permissible.

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

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

Irritable bowel syndrome

How to take part

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

  1. The places running it

    110 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. 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

Locations

  • GSK Investigational Site

    RECRUITING

    Anniston, Alabama, 36207, United States

  • GSK Investigational Site

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    Guntersville, Alabama, 35976, United States

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    Mobile, Alabama, 36608, United States

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    Saraland, Alabama, 36571, United States

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    Scottsdale, Arizona, 85260, United States

  • GSK Investigational Site

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    Tempe, Arizona, 85284, United States

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    Anaheim, California, 92804, United States

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    Chula Vista, California, 91910, United States

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    Coronado, California, 92118, United States

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    Garden Grove, California, 92845, United States

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    Lancaster, California, 93534, United States

  • GSK Investigational Site

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    Lancaster, California, 93534, United States

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    Los Angeles, California, 90015, United States

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    Murrieta, California, 92563, United States

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    Pasadena, California, 91105, United States

  • GSK Investigational Site

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    San Diego, California, 92103, United States

  • GSK Investigational Site

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    San Diego, California, 92120, United States

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    Sherman Oaks, California, 91403, United States

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    West Hills, California, 91307, United States

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    Aurora, Colorado, 80012, United States

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    Colorado Springs, Colorado, 80907, United States

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    Lone Tree, Colorado, 80124, United States

  • GSK Investigational Site

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    Brandon, Florida, 33511, United States

  • GSK Investigational Site

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    Clearwater, Florida, 33756, United States

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    Coral Gables, Florida, 33134, United States

  • GSK Investigational Site

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    Doral, Florida, 33126, United States

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    Hialeah, Florida, 33016, United States

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    Homestead, Florida, 33033, United States

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    Jacksonville, Florida, 32258, United States

  • GSK Investigational Site

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    Kissimmee, Florida, 34741, United States

  • GSK Investigational Site

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    Miami, Florida, 33126, United States

  • GSK Investigational Site

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    Miami, Florida, 33134, United States

  • GSK Investigational Site

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    Miami, Florida, 33144, United States

  • GSK Investigational Site

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    Miami, Florida, 33145, United States

  • GSK Investigational Site

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    Miami, Florida, 33157, United States

  • GSK Investigational Site

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    Miami, Florida, 33165, United States

  • GSK Investigational Site

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    Miami, Florida, 33173, United States

  • GSK Investigational Site

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    Miami, Florida, 33174, United States

  • GSK Investigational Site

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    Miami, Florida, 33186, United States

  • GSK Investigational Site

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    Miami Beach, Florida, 33141, United States

  • GSK Investigational Site

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    Miami Lakes, Florida, 33016, United States

  • GSK Investigational Site

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    Miami Springs, Florida, 33166, United States

  • GSK Investigational Site

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    New Port Richey, Florida, 34653, United States

  • GSK Investigational Site

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    Ocala, Florida, 34471, United States

  • GSK Investigational Site

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    Orlando, Florida, 32807, United States

  • GSK Investigational Site

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    Orlando, Florida, 32835, United States

  • GSK Investigational Site

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    Palm Harbor, Florida, 34684, United States

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    Pembroke Pines, Florida, 33024, United States

  • GSK Investigational Site

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    Pembroke Pines, Florida, 33026, United States

  • GSK Investigational Site

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    Sunrise, Florida, 33351, United States

  • GSK Investigational Site

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    Tampa, Florida, 33607, United States

  • GSK Investigational Site

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    Tampa, Florida, 33607, United States

  • GSK Investigational Site

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    Tampa, Florida, 33613, United States

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    Tampa, Florida, 33614, United States

  • GSK Investigational Site

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    Atlanta, Georgia, 30328, United States

  • GSK Investigational Site

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    Atlanta, Georgia, 30342-5006, United States

  • GSK Investigational Site

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    Decatur, Georgia, 30033, United States

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    Lawrenceville, Georgia, 30044, United States

  • GSK Investigational Site

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    Union City, Georgia, 30291, United States

  • GSK Investigational Site

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    Meridian, Idaho, 83646, United States

  • GSK Investigational Site

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    Morton, Illinois, 61550, United States

  • GSK Investigational Site

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    Oak Lawn, Illinois, 60453, United States

  • GSK Investigational Site

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    Ames, Iowa, 50010, United States

  • GSK Investigational Site

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    Houma, Louisiana, 70360, United States

  • GSK Investigational Site

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    Boston, Massachusetts, 02111, United States

  • GSK Investigational Site

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    Flint, Michigan, 48504, United States

  • GSK Investigational Site

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    Chesterfield, Missouri, 48038, United States

  • GSK Investigational Site

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    Hazelwood, Missouri, 63042, United States

  • GSK Investigational Site

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    Missoula, Montana, 59808, United States

  • GSK Investigational Site

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    Hartsdale, New York, 10530, United States

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    New Windsor, New York, 12553, United States

  • GSK Investigational Site

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    New York, New York, 10016, United States

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    North Massapequa, New York, 11758, United States

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    Richmond Hill, New York, 11418, United States

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    Rochester, New York, 14609, United States

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    Charlotte, North Carolina, 28210, United States

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    Fayetteville, North Carolina, 28304, United States

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    Greenville, North Carolina, 27834, United States

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    Rocky Mount, North Carolina, 27804, United States

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    Salisbury, North Carolina, 28144, United States

  • GSK Investigational Site

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    Winston-Salem, North Carolina, 27103, United States

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    Beavercreek, Ohio, 45431, United States

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    Columbus, Ohio, 43202, United States

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    Mentor, Ohio, 44060, United States

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    Norman, Oklahoma, 73071, United States

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    Tulsa, Oklahoma, 74104, United States

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    Harrisburg, Pennsylvania, 17110, United States

  • GSK Investigational Site

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    Pittsburgh, Pennsylvania, 15236, United States

  • GSK Investigational Site

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    Uniontown, Pennsylvania, 15401, United States

  • GSK Investigational Site

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    Chattanooga, Tennessee, 37404, United States

  • GSK Investigational Site

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    Chattanooga, Tennessee, 37412, United States

  • GSK Investigational Site

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    Johnson City, Tennessee, 37604, United States

  • GSK Investigational Site

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    Kingsport, Tennessee, 37663, United States

  • GSK Investigational Site

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    Knoxville, Tennessee, 37909, United States

  • GSK Investigational Site

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    Nashville, Tennessee, 37211, United States

  • GSK Investigational Site

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    Corsicana, Texas, 75110, United States

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    Georgetown, Texas, 78628, United States

  • GSK Investigational Site

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    Harlingen, Texas, 785500, United States

  • GSK Investigational Site

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    Houston, Texas, 77081, United States

  • GSK Investigational Site

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    Houston, Texas, 77099, United States

  • GSK Investigational Site

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    Mesquite, Texas, 75149, United States

  • GSK Investigational Site

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    Missouri City, Texas, 77459, United States

  • GSK Investigational Site

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    Pearland, Texas, 77584, United States

  • GSK Investigational Site

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    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

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    Ogden, Utah, 84403, United States

  • GSK Investigational Site

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    Ogden, Utah, 84405, United States

  • GSK Investigational Site

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    Sandy City, Utah, 84070, United States

  • GSK Investigational Site

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    Lynchburg, Virginia, 24502, United States

  • GSK Investigational Site

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    Petersburg, Virginia, 23805, United States

  • GSK Investigational Site

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    Richmond, Virginia, 23226, United States

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