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Enpatoran - Merck KGaA

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Drug Profile

Enpatoran - Merck KGaA

Alternative Names: M-5049

Latest Information Update: 30 Sep 2026

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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; Urologics
  • 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 III Cutaneous lupus erythematosus; Systemic lupus erythematosus
  • Phase II COVID-19 pneumonia
  • Phase I Renal failure
  • No development reported Immunological disorders; Unspecified

Most Recent Events

  • 25 Sep 2026 EMD Serono Research & Development Institute plans a phase III Elowen-LTE trial for Systemic lupus erythematosus and Cutaneous lupus erythematosus in USA and Germany (PO) in October 2026 (NCT07840287)
  • 08 Jul 2026 Enpatoran - Merck KGaA receives Breakthrough Therapy status for Systemic lupus erythematosus in USA
  • 06 Jun 2026 Efficacy and adverse events data from a phase II trial in Systemic Lupus Erythematosus presented at the 27th Annual Congress of the European League Against Rheumatism (EULAR-2026)

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