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Elinzanetant - Bayer

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Drug Profile

Elinzanetant - Bayer

Alternative Names: BAY-3427080; GSK 1144814A; GSK-1144814; Lynkuet; NT 814

Latest Information Update: 30 Jul 2025

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At a glance

  • Originator GlaxoSmithKline
  • Developer Bayer; GlaxoSmithKline; NeRRe Therapeutics
  • Class 2 ring heterocyclic compounds; Alcohols; Amides; Antipsychotics; Drug withdrawal therapies; Fluorinated hydrocarbons; Fluorobenzenes; Oxazines; Piperazines; Pyridines; Sleep disorder therapies; Small molecules
  • Mechanism of Action Neurokinin 1 receptor antagonists; Neurokinin 3 receptor antagonists
  • 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

  • Registered Vasomotor symptoms
  • Phase II Sleep disorders
  • Discontinued Opioid-related disorders; Schizophrenia

Most Recent Events

  • 25 Jul 2025 Registered for Vasomotor symptoms in Canada (PO), prior to July 2025
  • 25 Jul 2025 The US FDA extends PDUFA date up to 90 days for NDA review for Vasomotor symptoms (PO)
  • 25 Jul 2025 US FDA extends the review period for the NDA for elinzanetant for Vasomotor symptoms

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