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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 Feb 2024

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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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Fibromyalgia
  • Discontinued Diabetic neuropathies; Major depressive disorder; Postherpetic neuralgia; Stress incontinence

Most Recent Events

  • 04 Jan 2024 Axsome Therapeutics announces intention to submit NDA to the US FDA for Fibromyalgia in the first half of 2024
  • 27 Sep 2022 Esreboxetine is still in phase III clinical trials in Fibromyalgia in USA (PO) (Axsome Therapeutics website, September 2022)
  • 10 May 2021 Axsome Therapeutics met the US FDA for clinical development of esreboxetine for fibromyalgia, before May 2021
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