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Esreboxetine - Axsome Therapeutics

Drug Profile

Esreboxetine - Axsome Therapeutics

Alternative Names: [S,S]-Reboxetine; AXS-14; PNU-165442G

Latest Information Update: 23 Jan 2026

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At a glance

  • Originator Pfizer
  • Developer Axsome Therapeutics; Pfizer
  • Class Antidepressants; Morpholines; Small molecules; Urologics
  • Mechanism of Action Adrenergic uptake inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Fibromyalgia
  • Discontinued Diabetic neuropathies; Major depressive disorder; Postherpetic neuralgia; Urinary-Stress-Incontinence

Most Recent Events

  • 15 Jan 2026 Axsome Therapeutics initiates the phase III FORWARD trial in Fibromyalgia in USA (PO)
  • 04 Aug 2025 Axsome Therapeutics plans a phase III trial for Fibromyalgia in USA in fourth quarter of 2025 (PO)
  • 09 Jun 2025 Axsome Therapeutics receives Refusal to File letter from the US FDA for Esreboxetine in Fibromyalgia

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