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Donanemab - Eli Lilly and Company

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Drug Profile

Donanemab - Eli Lilly and Company

Alternative Names: Donanemab-azbt; Donanemab-azbt injection - Eli Lilly and Company; Kisunla; LY 3002813; LY-002813-SC; LY-3002813-IV; LY3002813-SC; N3pG-Ab MAb - Eli Lilly and Company; N3pG-AB-monoclonal antibody - Eli Lilly and Company; N3pG-amyloid-beta monoclonal antibody - Eli Lilly and Company

Latest Information Update: 31 Jul 2025

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At a glance

  • Originator Eli Lilly and Company
  • Class Antidementias; Monoclonal antibodies
  • Mechanism of Action Pyroglutamyl(3)-amyloid beta-protein (3-42) 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

  • Registered Alzheimer's disease

Most Recent Events

  • 25 Jul 2025 European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends approval of Donanemab for Alzheimer's disease in European union
  • 09 Jul 2025 US FDA approves a label update with a new recommended titration dosing schedule for donanemab for early symptomatic Alzheimer's disease in USA
  • 09 Jul 2025 Updated safety and efficacy data from the phase III TRAILBLAZER-ALZ 6 trial for Alzheimer's disease released by Eli Lilly and Company

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