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Enpatoran - Merck KGaA

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Drug Profile

Enpatoran - Merck KGaA

Alternative Names: M-5049

Latest Information Update: 01 Sep 2025

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At a glance

  • Originator EMD Serono Research & Development Institute; Merck KGaA
  • Class Amines; Anti-inflammatories; Antivirals; Nitriles; Piperidines; Quinolines; Skin disorder therapies; Small molecules
  • Mechanism of Action Toll-like receptor 7 antagonists; Toll-like receptor 8 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

  • Phase II COVID-19 pneumonia; Cutaneous lupus erythematosus; Systemic lupus erythematosus
  • No development reported Immunological disorders; Unspecified

Most Recent Events

  • 31 Aug 2025 Discontinued - Phase-II for Dermatomyositis (In the elderly, Treatment-experienced, In adults) in USA (PO) (Merck KGaA pipeline, August 2025)
  • 31 Aug 2025 Discontinued - Phase-II for Polymyositis (In the elderly, Treatment-experienced, In adults) in USA (PO) (Merck KGaA pipeline, August 2025)
  • 17 Jul 2025 EMD Serono terminates the phase-II NEPTUNIA trials in Dermatomyositis (In adults, In the elderly, Treatment-experienced) in USA, following interim analyses indicating futility (PO, Tablet) (NCT05650567)

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