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New fibromyalgia drug AXS-14 enters final testing phase

NCT ID NCT07398417

Symptom relief Sponsor: Axsome Therapeutics, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This Phase 3 study tests whether AXS-14 (esreboxetine) can help manage fibromyalgia symptoms like pain and fatigue. About 620 adults with fibromyalgia will take the drug or a placebo daily. The study uses a 'randomized withdrawal' design to see how long the drug's effects last.

What this could mean

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

Active substance
AXS-14 (esreboxetine) tablets taken once daily
What this could lead to
If successful, AXS-14 could offer a new daily medication option to help manage fibromyalgia pain and other symptoms.
What could go wrong
This is a Phase 3 trial, but it's a withdrawal study—meaning it tests if stopping the drug leads to symptom return. It may not work for everyone, and side effects are possible.

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 620 people

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

Started

Jan 2026

Expected to finish

Mar 2028

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 years and older

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: * Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria. * Male or female, ≥18 years of age. * Provides written informed consent to participate in the study before conducting any study procedures. Exclusion Criteria: * Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition. * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

fibromyalgia Hyperalgesia

As listed by the trial registrant

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

Fibromyalgia

How to take part

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

  1. The places running it

    53 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

  • Clinical Research Site

    RECRUITING

    Glendale, Arizona, 85308, United States

  • Clinical Research Site

    RECRUITING

    Phoenix, Arizona, 85032, United States

  • Clinical Research Site

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Clinical Research Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Clinical Research Site

    RECRUITING

    Anaheim, California, 92801, United States

  • Clinical Research Site

    RECRUITING

    Oceanside, California, 92056, United States

  • Clinical Research Site

    RECRUITING

    Redlands, California, 92374, United States

  • Clinical Research Site

    RECRUITING

    Sacramento, California, 95821, United States

  • Clinical Research Site

    RECRUITING

    Santa Ana, California, 92705, United States

  • Clinical Research Site

    RECRUITING

    Cromwell, Connecticut, 06416, United States

  • Clinical Research Site

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Clinical Research Site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    RECRUITING

    Lakeland, Florida, 33803, United States

  • Clinical Research Site

    RECRUITING

    Maitland, Florida, 32751, United States

  • Clinical Research Site

    RECRUITING

    Orlando, Florida, 32801, United States

  • Clinical Research Site

    RECRUITING

    Orlando, Florida, 32832, United States

  • Clinical Research Site

    RECRUITING

    Tampa, Florida, 33634, United States

  • Clinical Research Site

    RECRUITING

    The Villages, Florida, 32159, United States

  • Clinical Research Site

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Clinical Research Site

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Clinical Research Site

    RECRUITING

    Marietta, Georgia, 30060, United States

  • Clinical Research Site

    RECRUITING

    Norcross, Georgia, 30092, United States

  • Clinical Research Site

    RECRUITING

    Chicago, Illinois, 60634, United States

  • Clinical Research Site

    RECRUITING

    Tinley Park, Illinois, 60477, United States

  • Clinical Research Site

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Clinical Research Site

    RECRUITING

    Overland Park, Kansas, 66209, United States

  • Clinical Research Site

    RECRUITING

    Overland Park, Kansas, 66212, United States

  • Clinical Research Site

    RECRUITING

    Louisville, Kentucky, 40205, United States

  • Clinical Research Site

    RECRUITING

    Prairieville, Louisiana, 70769, United States

  • Clinical Research Site

    RECRUITING

    Boston, Massachusetts, 02131, United States

  • Clinical Research Site

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Clinical Research Site

    RECRUITING

    Hazelwood, Missouri, 63042, United States

  • Clinical Research Site

    RECRUITING

    Springfield, Missouri, 65807, United States

  • Clinical Research Site

    RECRUITING

    Town and Country, Missouri, 63017, United States

  • Clinical Research Site

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • Clinical Research Site

    RECRUITING

    Brooklyn, New York, 11235, United States

  • Clinical Research Site

    RECRUITING

    Hartsdale, New York, 10530, United States

  • Clinical Research Site

    RECRUITING

    Williamsville, New York, 14221, United States

  • Clinical Research Site

    RECRUITING

    Huber Heights, Ohio, 45424, United States

  • Clinical Research Site

    RECRUITING

    Milford, Ohio, 45150, United States

  • Clinical Research Site

    RECRUITING

    Tulsa, Oklahoma, 74133, United States

  • Clinical Research Site

    RECRUITING

    Duncansville, Pennsylvania, 16635, United States

  • Clinical Research Site

    RECRUITING

    Cranston, Rhode Island, 02920, United States

  • Clinical Research Site

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Clinical Research Site

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site

    RECRUITING

    Austin, Texas, 78731, United States

  • Clinical Research Site

    RECRUITING

    Austin, Texas, 78737, United States

  • Clinical Research Site

    RECRUITING

    Dallas, Texas, 75251, United States

  • Clinical Research Site

    RECRUITING

    Houston, Texas, 77089, United States

  • Clinical Research Site

    RECRUITING

    Prosper, Texas, 75078, United States

  • Clinical Research Site

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Clinical Research Site

    RECRUITING

    The Woodlands, Texas, 77832, United States

  • Houston

    RECRUITING

    High Point, North Carolina, 27260, United States

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