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New pill for bladder pain shows promise in early trial

NCT ID NCT06285214

Symptom relief Sponsor: Imbrium Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a drug called V117957 in 47 women with interstitial cystitis, a condition causing bladder pain and discomfort. Participants took either the drug or a placebo at bedtime to see if it safely reduced pain. The trial is now complete, and results will help decide if larger studies are warranted.

What this could mean

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

Active substance
V117957
What this could lead to
If it works, this could point toward a new treatment option for bladder pain in interstitial cystitis.
What could go wrong
This is an early Phase 1 trial with only 47 participants, so results may not apply to everyone. The drug may not prove effective or could have side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

47 people

The number who actually took part.

Started

May 2022

Finished

Jan 2025

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 years and older

Sex

Female participants only

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.

Key Inclusion Criteria include: 1. Female, age ≥18 years and capable of voiding independently. Able to comply with acceptable methods of contraception. 2. Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms for more than six weeks duration, in the absence of infection or other identifiable causes". 3. Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9. 4. Has undergone evaluation to rule out other conditions that cause bladder pain/discomfort. Any microscopic or gross hematuria that has not been evaluated in the past 12 months will require appropriate clinical evaluation to determine study eligibility. Key Exclusion Criteria include: 1. Pelvic floor tenderness in the absence of bladder tenderness on physical examination by primary investigator. 2. Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI. 3. Hematuria determined to be associated with bladder malignancy or other significant pathology. 4. Had surgical procedure at any time that affected bladder function. 5. Received intravesical therapy or had bladder hydrodistension, fulguration, botulinum toxin, or triamcinolone bladder injection, percutaneous nerve stimulation. A subject receiving such treatment(s) prior to screening is eligible if in the opinion of the investigator the procedure/ treatment resulted in no notable or enduring effect and subject continues to exhibit stable symptomology. 6. Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis. Other protocol-specific inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

interstitial cystitis

As listed by the trial registrant

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

Interstitial cystitis/bladder pain syndrome

Contacts and locations

Locations

  • Accel Research Site - Neurostudies

    Decatur, Georgia, 30033, United States

  • Accel Research Sites

    DeLand, Florida, 32720, United States

  • AccuMed Research Associates

    Garden City, New York, 11530, United States

  • Adult & Pediatric Urology P.C.

    Omaha, Nebraska, 68114, United States

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212, United States

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts, 02472, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CentraCare - Urology Clinic

    Sartell, Minnesota, 56377, United States

  • Chesapeake Urology Research Associates

    Owings Mills, Maryland, 21117, United States

  • Hope Clinical Research, LLC

    Los Angeles, California, 91303, United States

  • Investigational Site

    Escondido, California, 92025, United States

  • Manhattan Medical Research Practice

    New York, New York, 10016, United States

  • MetroHealth System

    Cleveland, Ohio, 44109, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Ochsner Louisiana State University Health Shreveport - Regional University

    Shreveport, Louisiana, 71106, United States

  • Otrimed Clinical Research

    Edgewood, Kentucky, 41017, United States

  • Providea Health Partners LLC

    Evergreen Park, Illinois, 60805, United States

  • Revive Research Institute, Inc

    Dearborn Heights, Michigan, 48127, United States

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001, United States

  • Tri Valley Urology Medical Group

    Murrieta, California, 92562, United States

  • Unified Women's Clinical Research-Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103, United States

  • Urological Associates of Southern Arizona

    Tucson, Arizona, 85715, United States

  • Urology Centers of Alabama, PC

    Homewood, Alabama, 35209, United States

  • Urology Group of Southern California

    Los Angeles, California, 90017, United States