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A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE

Trial Profile

A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants With Hereditary Angioedema - ORBIT-EXPANSE

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2025

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At a glance

  • Drugs Navenibart (Primary)
  • Indications Hereditary angioedema
  • Focus Adverse reactions; Registrational
  • Acronyms ORBIT-EXPANSE
  • Sponsors Astria Therapeutics

Most Recent Events

  • 12 Nov 2025 According to an Astria Therapeutics media release, First Patient Now Enrolled in the ORBIT-EXPANSE Long-Term Extension trial.
  • 08 Oct 2025 According to an Astria Therapeutics media release, After completing ALPHA-ORBIT, eligible participants may continue into the ORBIT-EXPANSE trial, in which all participants will receive navenibart in either Q3M or Q6M regimens.
  • 08 Oct 2025 According to an Astria Therapeutics media release, company announced the initiation of the Phase 3 ORBIT-EXPANSE long-term trial of navenibart in people living with hereditary angioedema (HAE).

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