AXS-14 (Esreboxetine)

Phase 3Small molecule

AAxsome Therapeutics, Inc.

AXS-14 (Esreboxetine) is one of 34 small molecule programs targeting Fibromyalgia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

FibromyalgiaRecruiting

FibromyalgiaPhase 3

Recruiting

Competition

Competitive Landscape

42 competitors in Fibromyalgia

#DrugCompanyPhaseTrials

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

36 2

Savella

AbbVie

Approved

15 3

Cymbalta

Jazz Pharmaceuticals

Approved

14 4

Elavil

AstraZeneca

Approved

4 5

Keppra

UCB

Approved

1 6

Emgality

Eli Lilly

Approved

1 7

Revia

Xylocaine

4 9

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Approved

4 10

Nuvigil

NNuvo Research GmbH

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 3Recruiting

Fibromyalgia

NCT07398417

Clinical

Trials by Indication[1]

Fibromyalgia2 trials

An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia

Enrolling by invitation·AAxsome Therapeutics, Inc.·Phase 3·NCT07637162·300 enrolled

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia

Recruiting·AAxsome Therapeutics, Inc.·Phase 3·NCT07398417·620 enrolled

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for AXS-14 (Esreboxetine). U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AXS-14 (Esreboxetine) compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AXS-14 (Esreboxetine). EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Axsome Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAxsome Therapeutics, Inc.

AXS-14 (Esreboxetine)

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Fibromyalgia2 trials

References

Drug Info

Quick Facts

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