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ART 5803

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Drug Profile

ART 5803

Alternative Names: ART-5803

Latest Information Update: 13 Jul 2026

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At a glance

  • Originator Arialys Therapeutics
  • Class Monoclonal antibodies
  • Mechanism of Action Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Anti-N-methyl-D-aspartate receptor encephalitis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Anti-N-methyl-D-aspartate receptor encephalitis

Most Recent Events

  • 09 Jul 2026 ART 5803 receives Fast track status from the US FDA for Anti-N-methyl-D-aspartate receptor encephalitis
  • 09 Jul 2026 ART 5803 receives Orphan Drug status for Anti-N-methyl-D-aspartate receptor encephalitis in South Korea
  • 15 Jun 2026 USFDA approves IND application for ART 5803 in Anti-N-methyl-D-aspartate receptor encephalitis

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