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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: 03 Jul 2026

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At a glance

  • Originator Quellis Biosciences
  • Developer BioCryst Pharmaceuticals
  • Class Monoclonal antibodies; Plasma expanders; 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

  • 30 Jun 2026 BioCryst Pharmaceuticals completes enrolment in the Phase-III clinical trials in Hereditary angioedema (In adults, In adolescents, In the elderly) in USA, Canada, Bulgaria, Hong Kong, Netherland, Poland, South Africa, United Kingdom, Australia, Austria, Brazil, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, New Zealand, Macedonia, Portugal, Puerto Rico, South Korea and Spain(SC) (NCT06842823)
  • 04 May 2026 Navenibart licensed to Neopharmed Gentili in Europe
  • 21 Apr 2026 Astria Therapeutics initiates enrolment in a phase I trial (In volunteers) in USA (SC) (NCT07635095)

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