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Navenibart - Astria Therapeutics

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Drug Profile

Navenibart - Astria Therapeutics

Alternative Names: QLS-215; STAR-0215

Latest Information Update: 28 Aug 2025

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At a glance

  • Originator Quellis Biosciences
  • Developer Astria Therapeutics
  • Class Monoclonal antibodies; Plasma expanders; Skin disorder therapies; Vascular disorder therapies
  • Mechanism of Action Plasma kallikrein inhibitors
  • Orphan Drug Status

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

    Yes - Hereditary angioedema
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Hereditary angioedema

Most Recent Events

  • 28 Aug 2025 No recent reports of development identified for phase-I development in Hereditary-angioedema(In volunteers) in USA (IV, Injection)
  • 06 Aug 2025 Navenibart licensed to Kaken Pharmaceutical in Japan
  • 13 Jun 2025 Adverse events and efficacy data from a phase II ALPHA-SOLAR trial in Hereditary angioedema released by Astria Therapeutics

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