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ART 5803

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Drug Profile

ART 5803

Alternative Names: ART-5803

Latest Information Update: 01 Oct 2025

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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 I Anti-N-methyl-D-aspartate receptor encephalitis

Most Recent Events

  • 25 Sep 2025 US FDA grants Rare Pediatric Disease Designation to ART 5803 for Anti-N-methyl-D-aspartate receptor encephalitis in USA
  • 11 Sep 2025 Arialys Therapeutics completes a phase I trial for anti N-methyl-D-aspartate receptor encephalitis (In volunteers) in Australia (IV, Infusion) (NCT06575153)
  • 18 Jun 2025 Pharmacodynamics data from a preclinical studies in Anti-N-methyl-D-aspartate receptor encephalitis released by Arialys Therapeutics

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