New fibromyalgia drug AXS-14 enters final testing phase

NCT ID NCT07398417

Recruiting now Symptom relief Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 24, 2026 · Updated 2 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.

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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

Contacts and locations

Locations

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Glendale, Arizona, 85308, United States
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Phoenix, Arizona, 85032, United States
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Tucson, Arizona, 85704, United States
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Little Rock, Arkansas, 72211, United States
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Anaheim, California, 92801, United States
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Oceanside, California, 92056, United States
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Redlands, California, 92374, United States
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Sacramento, California, 95821, United States
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Santa Ana, California, 92705, United States
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Cromwell, Connecticut, 06416, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32256, United States
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Lakeland, Florida, 33803, United States
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Maitland, Florida, 32751, United States
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Orlando, Florida, 32801, United States
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Orlando, Florida, 32832, United States
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Tampa, Florida, 33634, United States
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The Villages, Florida, 32159, United States
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Atlanta, Georgia, 30328, United States
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Atlanta, Georgia, 30329, United States
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Marietta, Georgia, 30060, United States
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Norcross, Georgia, 30092, United States
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Chicago, Illinois, 60634, United States
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Tinley Park, Illinois, 60477, United States
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Overland Park, Kansas, 66209, United States
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Overland Park, Kansas, 66210, United States
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Louisville, Kentucky, 40205, United States
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Prairieville, Louisiana, 70769, United States
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Boston, Massachusetts, 02131, United States
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Watertown, Massachusetts, 02472, United States
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Hazelwood, Missouri, 63042, United States
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Springfield, Missouri, 65807, United States
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Town and Country, Missouri, 63017, United States
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Las Vegas, Nevada, 89102, United States
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Brooklyn, New York, 11235, United States
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Hartsdale, New York, 10530, United States
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Williamsville, New York, 14221, United States
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Huber Heights, Ohio, 45424, United States
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Milford, Ohio, 45150, United States
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Tulsa, Oklahoma, 74133, United States
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Duncansville, Pennsylvania, 16635, United States
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Cranston, Rhode Island, 02920, United States
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Knoxville, Tennessee, 37909, United States
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Memphis, Tennessee, 38119, United States
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Austin, Texas, 78731, United States
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Austin, Texas, 78737, United States
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Dallas, Texas, 75251, United States
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Houston, Texas, 77089, United States
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Prosper, Texas, 75078, United States
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San Antonio, Texas, 78240, United States
Houston
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High Point, North Carolina, 27260, United States

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