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New Non-Opioid drug VX-548 tested for chronic leg nerve pain

NCT ID NCT06176196

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 2 trial tested the drug VX-548 (Suzetrigine) in 218 adults with painful lumbosacral radiculopathy, a condition where a pinched nerve in the lower back causes leg pain. The study compared the drug to a placebo to see if it safely reduces leg pain and improves sleep. Results will show whether this non-opioid option might help people with chronic nerve pain.

What this could mean

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

Active substance
VX-548 (Suzetrigine) tablets
What this could lead to
If successful, this could lead to a new non-opioid painkiller for nerve-related leg pain, offering relief without addiction risks.
What could go wrong
This is an early Phase 2 trial with only 218 people, so results may not apply to everyone. The drug might not reduce pain better than placebo, and side effects are still being studied.

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

218 people

The number who actually took part.

Started

Dec 2023

Finished

Oct 2024

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 70 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) less than or equal to (\<=) 40 kg/ meter square (m\^2) * Diagnosis of PLSR for greater than (\>)3 months as per criteria pre-specified in the protocol * Weekly average of daily NPRS score \>=4 and \<10 with limited variation in the 7-day Run-in Period Key Exclusion Criteria: * More than 3 missing daily NPRS scores during the 7-day Run-in Period * Moderate or severe painful neuropathy other than PLSR as pre-specified in the protocol * History of prior lumbar spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion) Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

radiculopathy

As listed by the trial registrant

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

Painful lumbosacral radiculopathy

Contacts and locations

Locations

  • AES Dallas Forth Worth

    Dallas, Texas, 75234, United States

  • AES New York

    New York, New York, 10017, United States

  • AMR Las Vegas (Clinical Research Consortium)

    Las Vegas, Nevada, 89119, United States

  • AMR Norfolk

    Norfolk, Virginia, 23502, United States

  • AMR Norman

    Norman, Oklahoma, 73069, United States

  • AMR Wichita East, KS

    Wichita, Kansas, 67207, United States

  • ARSN-Brain and Spine Institute

    Port Orange, Florida, 32127, United States

  • Accel Research Site - St. Petersburg/Largo

    Seminole, Florida, 33777, United States

  • Accel Research Sites - Neurostudies

    Decatur, Georgia, 30030, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Arizona Research Center

    Phoenix, Arizona, 85053, United States

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331, United States

  • Be Well Clinical Studies - Austin

    Round Rock, Texas, 78681, United States

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska, 68516, United States

  • Brigham and Women's Hospital (BWH)

    Boston, Massachusetts, 02115, United States

  • Center for Pain Management and Rehab

    Stockbridge, Georgia, 30281, United States

  • ClinCept Clinical Research

    Columbus, Georgia, 31904, United States

  • Clinical Investigations LLC.

    Edmond, Oklahoma, 73034, United States

  • Clinical Trials of South Carolina - Charleston

    Charleston, South Carolina, 29406, United States

  • Convenient Medical Research

    Hialeah, Florida, 33013, United States

  • Essential Concepts Research Solutions

    Palos Hills, Illinois, 60465, United States

  • Expert Pain

    Houston, Texas, 77079, United States

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003, United States

  • Healthcare Research Network

    Hazelwood, Missouri, 63042, United States

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422, United States

  • Hope Research Institute

    Phoenix, Arizona, 85018, United States

  • JBR Clinical Research

    Salt Lake City, Utah, 84107, United States

  • JY Research Institute

    Cutler Bay, Florida, 33189, United States

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216, United States

  • L&C Professional Medical Research Institute

    Miami, Florida, 33144, United States

  • Lubbock Spine Institute

    Lubbock, Texas, 79410, United States

  • META Medical Research Institute

    Dayton, Ohio, 45432, United States

  • MedVadis Research Coorporation

    Waltham, Massachusetts, 02451, United States

  • Medical Research of Westchester

    Miami, Florida, 33165, United States

  • Nature Coast Clinical Research - Crystal River

    Crystal River, Florida, 34429, United States

  • NexGen Research

    Lima, Ohio, 45805, United States

  • Pacific Sports and Spine

    Eugene, Oregon, 97404, United States

  • Pain Management and Injury Relief

    Thousand Oaks, California, 91320, United States

  • Probe Clinical Research

    Riverside, California, 92501, United States

  • St. Louis Pain Consultants

    Chesterfield, Missouri, 63017, United States

  • Synexus Clinical Research - Henderson

    Henderson, Nevada, 89052, United States

  • Trovare Clinical Research

    Bakersfield, California, 93301, United States

  • Velocity Clinical Research - Banning

    Banning, California, 92220, United States

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon, 97527, United States

  • Velocity Clinical Research - Hampton

    Hampton, Virginia, 23666, United States

  • Velocity Clinical Research - Portsmouth

    Portsmouth, Virginia, 23703, United States

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research - Rockville

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research - San Diego

    La Mesa, California, 91942, United States

  • Velocity Clinical Research - Savannah

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research - Savannah Neurology Specialists

    Savannah, Georgia, 31406, United States

  • Visionary Investigators Network

    Aventura, Florida, 33180, United States