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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: 13 Nov 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

  • 06 Nov 2025 Final adverse events and efficacy data from the phase-Ib/II ALPHA-STAR trial in Hereditary angioedema released by Astria Therapeutics
  • 03 Oct 2025 Phase-III clinical trials in Hereditary angioedema (In adolescents, In adults, In the elderly) in European Union (SC) (NCT06842823)
  • 01 Oct 2025 Phase-III clinical trials in Hereditary angioedema (Prevention, In adults, In the elderly, In adolescents, Treatment-experienced) in USA (SC) (NCT07204938)

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