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Narsoplimab - Omeros Corporation

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Drug Profile

Narsoplimab - Omeros Corporation

Alternative Names: anti-MASP-2 monoclonal antibody; MASP-2 antibody - Omeros Corporation; MASP-2 therapeutic; OMS 00620646; OMS 620646; OMS 721

Latest Information Update: 03 Jul 2025

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At a glance

  • Originator Omeros Corporation
  • Developer Omeros Corporation; Quantum Leap Healthcare Collaborative
  • Class Anti-inflammatories; Antithrombotics; Eye disorder therapies; Monoclonal antibodies; Urologics; Vascular disorder therapies
  • Mechanism of Action Immunomodulators; MASP2 protein inhibitors
  • Orphan Drug Status

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

    Yes - Thrombotic microangiopathies; IgA nephropathy
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Thrombotic microangiopathies
  • Phase III Haemolytic uraemic syndrome; IgA nephropathy; Immediate hypersensitivity
  • Phase II Glomerulonephritis; Lupus nephritis; Membranous glomerulonephritis; SARS-CoV-2 acute respiratory disease
  • Preclinical Adult respiratory distress syndrome
  • No development reported Stroke; Wet age-related macular degeneration

Most Recent Events

  • 27 Jun 2025 Preregistration for Thrombotic microangiopathies in European Union (IV)
  • 27 Jun 2025 Omeros Corporation anticipates CHMP opinion for Thrombotic microangiopathes in mid-2026
  • 06 May 2025 US FDA assigns PDUFA action date of 25/09/2025 for Narsoplimab for Thrombotic microangiopathies

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