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New pill could ease diabetic nerve pain without opioids

NCT ID NCT07231419

Symptom relief Sponsor: Vertex Pharmaceuticals Incorporated 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Updated 2 times

Summary

This phase 3 trial tests suzetrigine, an experimental oral drug, for pain caused by diabetic peripheral neuropathy. About 734 adults with diabetes and nerve pain in their legs for at least a year will receive either the drug or a placebo. The main goal is to see if suzetrigine reduces average daily pain over 12 weeks better than placebo.

What this could mean

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

Active substance
suzetrigine (also called VX-548), an oral tablet
What this could lead to
If it works, this could provide a new non-opioid painkiller for people with diabetic nerve pain, improving daily comfort and quality of life.
What could go wrong
This is a phase 3 trial, but pain studies often fail due to high placebo response. The drug may not work better than placebo or could have side effects not yet seen.

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 734 people

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

Started

Nov 2025

Expected to finish

Apr 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.

Key Inclusion Criteria: * Body weight greater than or equal to (≥)45 kilogram (kg) * Body mass index (BMI) ≥18 to less than (\<) 40 kilogram per meter square (kg/m\^2) * Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN for at least 1 year * Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period Key Exclusion Criteria: * More than 3 missing daily NPRS scores during the 7-day Baseline Period * Received Journavx within 30 days of study drug dosing * Any sensory abnormality (excluding DPN) as pre-specified in the protocol Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

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

Diabetic peripheral neuropathic pain

How to take part

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

  1. The places running it

    70 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

  • 3Sync Research - Palm Springs

    RECRUITING

    Palm Springs, Florida, 33461, United States

  • 3Sync Research -Miami Lakes

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • AMR Kansas City

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • AMR Knoxville, TN

    COMPLETED

    Knoxville, Tennessee, 37909, United States

  • AMR Mobile

    COMPLETED

    Mobile, Alabama, 36608, United States

  • AMR Norfolk

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Accel Research - Birmingham

    RECRUITING

    Birmingham, Alabama, 35216, United States

  • Accel Research - Decatur

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Accel Research - Deland

    RECRUITING

    DeLand, Florida, 32720, United States

  • Alpine Clinical Research Center

    RECRUITING

    Boulder, Colorado, 80301, United States

  • Amarillo Medical Specialists LLP

    RECRUITING

    Amarillo, Texas, 79124, United States

  • Aqualane Clinical Research

    COMPLETED

    Naples, Florida, 34105, United States

  • Artemis Institute for Clinical Research - Riverside

    RECRUITING

    Riverside, California, 92503, United States

  • Asheville Clinical Research

    RECRUITING

    Asheville, North Carolina, 28803, United States

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Boston Clinical Trials

    RECRUITING

    Boston, Massachusetts, 02131, United States

  • Brooklyn Clinical Research

    RECRUITING

    Brooklyn, New York, 11226, United States

  • CNS Healthcare - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • CNS Healthcare - Memphis

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • CNS Healthcare - Orlando

    RECRUITING

    Orlando, Florida, 32806, United States

  • CenExel AMRI

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • Central Research Associates, LLC

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • Chase Medical Research

    RECRUITING

    Waterbury, Connecticut, 06708, United States

  • ClinCloud - Viera

    RECRUITING

    Viera, Florida, 32940, United States

  • Clinical Trials of Texas, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Coastal Carolina Research Center

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Conquest Clinical Research - Winter Park

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Epic Clinical Research

    RECRUITING

    Lewisville, Texas, 75057, United States

  • Eximia Research-CA, LLC

    RECRUITING

    La Mesa, California, 91942, United States

  • Fort Worth Endocrine Research Center

    RECRUITING

    Fort Worth, Texas, 76132, United States

  • Health Awareness, Inc. - Jupiter

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Health Awareness, Inc. - Port St. Lucie

    RECRUITING

    Port Saint Lucie, Florida, 34952, United States

  • Healthcare Research Network - Flossmoor IL

    RECRUITING

    Tinley Park, Illinois, 60477, United States

  • Healthcare Research Network - Hazelwood MO

    RECRUITING

    Hazelwood, Missouri, 63042, United States

  • Holston Medical Group

    RECRUITING

    Kingsport, Tennessee, 37660, United States

  • Hope Clinical Research

    RECRUITING

    Canoga Park, California, 91303, United States

  • Javara Inc./Privia Medical Group - Fayetteville, GA

    RECRUITING

    Fayetteville, Georgia, 30214, United States

  • Long Beach Research Institute

    RECRUITING

    Long Beach, California, 90805, United States

  • Lynn Institute of Norman

    RECRUITING

    Norman, Oklahoma, 73072, United States

  • Lynn Institute of the Ozarks

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • M3 Wake Research - Chattanooga

    RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • M3 Wake Research - Las Vegas

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Marvel Clinical Research

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Mid Hudson Medical Research, PLLC

    RECRUITING

    New Windsor, New York, 12553, United States

  • Monroe Biomedical research

    RECRUITING

    Monroe, North Carolina, 28112, United States

  • Neurology Offices of South Florida, PLLC

    RECRUITING

    Boca Raton, Florida, 33428, United States

  • Paradigm Clincial Research - Modesto

    RECRUITING

    Modesto, California, 95355, United States

  • Paradigm Clinical Research - Wheat Ridge

    RECRUITING

    Wheat Ridge, Colorado, 80033, United States

  • Pasadena Clinical Trials

    RECRUITING

    Pasadena, California, 91101, United States

  • Prime Clinical Research - Mansfield - US 287

    RECRUITING

    Mansfield, Texas, 76063, United States

  • QCR - BioBehavioral Research of Austin

    RECRUITING

    Austin, Texas, 78759, United States

  • Quest Research Institute

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Rochester Clinical Research - Rochester

    RECRUITING

    Rochester, New York, 14609, United States

  • SCLA Management - St. Louis Pain Consultants

    COMPLETED

    Creve Coeur, Missouri, 63141, United States

  • Scottsdale Clinical Trials

    RECRUITING

    Scottsdale, Arizona, 85260, United States

  • Sun City Clinical Research

    RECRUITING

    Glendale, Arizona, 85304, United States

  • Suncoast Clinical Research - Palm Harbor

    COMPLETED

    Palm Harbor, Florida, 34684, United States

  • Velocity Clinical Research - Anderson

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Velocity Clinical Research - Baton Rouge

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Velocity Clinical Research - Cincinnati - Blue Ash

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research - Cleveland

    RECRUITING

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research - Gulfport

    RECRUITING

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research - Hallandale Beach

    RECRUITING

    Hallandale, Florida, 33009, United States

  • Velocity Clinical Research - Lafayette

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research - Medford

    RECRUITING

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - Providence

    RECRUITING

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research - Rockville

    RECRUITING

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research - Savannah

    RECRUITING

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research - Spartanburg

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • Velocity Clinical Research - Spokane

    RECRUITING

    Spokane, Washington, 99218, United States

  • Velocity Clinical Research - Syracuse

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Velocity Clinical Research - Washington DC

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Velocity Clinical Research -San Bernardino

    RECRUITING

    San Bernardino, California, 92408, United States

  • West Clinical Research

    RECRUITING

    Morehead City, North Carolina, 28557, United States

  • Zenos Clinical Research

    RECRUITING

    Dallas, Texas, 75230, United States

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