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New pill could ease diabetic nerve pain for good

NCT ID NCT06696443

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests a drug called suzetrigine (VX-548) for long-term safety and pain relief in people with diabetic peripheral neuropathy. About 455 adults who completed a prior 12-week study will take the drug for up to one year. Researchers will track side effects and changes in pain and quality of life.

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 known as VX-548), an oral tablet
What this could lead to
If it works, this could provide a new, long-term pain relief option for people with diabetic nerve pain.
What could go wrong
This is an open-label study with no placebo, so results may be less reliable. Side effects are still being monitored, and the drug may not work for everyone.

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

455 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Jan 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: • Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111 Key Exclusion Criteria: * Any sensory abnormality (excluding DPN) * History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator * Current participation in an investigational drug trial (other than a parent study) Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • 3Sync Research - Miami Lakes

    Miami Lakes, Florida, 33014, United States

  • AMR Daphne, AL

    Daphne, Alabama, 36526, United States

  • AMR Fort Myers (The Clinical Study Center)

    Fort Myers, Florida, 33912, United States

  • AMR Kansas City

    Kansas City, Missouri, 64114, United States

  • AMR Lexington

    Lexington, Kentucky, 40509, United States

  • AMR Wichita East, KS (Heartland Research Associates)

    Wichita, Kansas, 67207, United States

  • AMR-Miami

    Coral Gables, Florida, 33134, United States

  • Accel Research - Decatur

    Decatur, Georgia, 30030, United States

  • Accel Research - Deland

    DeLand, Florida, 32720, United States

  • Accel Research Site - St. Petersburg/Largo

    Largo, Florida, 33777, United States

  • Accel Research Sites - Maitland

    Maitland, Florida, 32751, United States

  • Angel City Research, Inc

    Los Angeles, California, 90010, United States

  • Be Well Clinical Studies - Austin

    Round Rock, Texas, 78681, United States

  • CNS Healthcare - Jacksonville

    Jacksonville, Florida, 32256, United States

  • Carolinas Pain Institute - Winston-Salem Office

    Winston-Salem, North Carolina, 27103, United States

  • Clinical Trials Research

    Sacramento, California, 95821, United States

  • Clinical Trials of South Carolina - Charleston

    Charleston, South Carolina, 29406, United States

  • Columbia Presbyterian - The Neurological Institute of New York

    New York, New York, 10032, United States

  • Conquest Clinical Research - Orlando - Neuro

    Orlando, Florida, 32832, United States

  • Conquest Clinical Research - Winter Park

    Winter Park, Florida, 32789, United States

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219, United States

  • Empire Clinical Research

    Pomona, California, 91767, United States

  • Eximia Research - Raleigh

    Raleigh, North Carolina, 27607, United States

  • Feinberg School of Medicine - Anesthesiology

    Chicago, Illinois, 60611, United States

  • HRI - Hassman Research Institute

    Marlton, New Jersey, 08053, United States

  • Healthcare Research Network - Flossmoor IL

    Tinley Park, Illinois, 604773027, United States

  • Healthcare Research Network - Hazelwood MO

    Hazelwood, Missouri, 63042, United States

  • Kalo Clinical Research - Salt Lake City

    Salt Lake City, Utah, 84102, United States

  • Long Beach Research Institute

    Long Beach, California, 90805, United States

  • M3 Wake Research - Charleston

    Charleston, South Carolina, 29414, United States

  • META Medical Research Institute

    Dayton, Ohio, 45432, United States

  • Mass General Brigham - Brigham and Women's Hospital - Main Campus

    Boston, Massachusetts, 02115, United States

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451, United States

  • Neuro-Pain Medical Center

    Fresno, California, 93710, United States

  • Northwest Clinical Research Center (NWCRC)

    Bellevue, Washington, 98007, United States

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207, United States

  • SCLA Management - Pain Management and Injury Relief

    Thousand Oaks, California, 91320, United States

  • San Antonio Clinical Trials

    San Antonio, Texas, 78240, United States

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260, United States

  • Suburban Research Associates - Media

    Media, Pennsylvania, 19063, United States

  • Suncoast Clinical Research - New Port Richey

    New Port Richey, Florida, 34652, United States

  • Suncoast Research Associates - Miami

    Doral, Florida, 33172, United States

  • Swift Clinical OpCo, Inc

    Brooklyn, New York, 11226, United States

  • Synexus Clinical Research - Cincinnati

    Cincinnati, Ohio, 45236, United States

  • Synexus Clinical Research - Evansville

    Evansville, Indiana, 47714, United States

  • Synexus Clinical Research - New York (DRS)

    New York, New York, 10017, United States

  • Synexus Clinical Research- Anderson

    Anderson, South Carolina, 29621, United States

  • Tandem Clinical Research- Covington

    Covington, Louisiana, 70433, United States

  • Velocity Clinical Research - Albuquerque

    Albuquerque, New Mexico, 87107, United States

  • Velocity Clinical Research - Baton Rouge

    Baton Rouge, Louisiana, 70809, United States

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research - Cleveland

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research - Denver

    Englewood, Colorado, 80110, United States

  • Velocity Clinical Research - Hallandale Beach

    Hallandale, Florida, 33009, United States

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - Norfolk

    Norfolk, Nebraska, 68701, United States

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research - Salt Lake City

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research - Spartanburg

    Spartanburg, South Carolina, 29303, United States

  • Velocity Clinical Research - Syracuse

    East Syracuse, New York, 13057, United States

  • Velocity Clinical Research - Waco

    Waco, Texas, 76710, United States

  • Velocity Clinical Research - Washington DC

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

  • Velocity Clinical Research, San Bernardino

    San Bernardino, California, 92408, United States

  • West Clinical Research

    Morehead City, North Carolina, 28557, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

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Other studies related to the condition(s) this trial covers.