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A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients With Hereditary Angioedema (HAE)

Trial Profile

A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients With Hereditary Angioedema (HAE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Mar 2025

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At a glance

  • Drugs Donidalorsen (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms OASIS-HAE
  • Sponsors Ionis Pharmaceuticals

Most Recent Events

  • 06 Mar 2025 According to Ionis Pharmaceuticals media release, EMA has accepted for review the marketing authorisation application for the hereditary angioedema drug candidate donidalorsen (ISIS 721744) for routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents aged 12 years and older.
  • 20 Feb 2025 According to Ionis Pharmaceuticals media release, company will present data from the Phase 3 OASIS-HAE Study at at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) Joint Congress in San Diego, California on March 2, 2025.
  • 06 Nov 2024 According to Ionis Pharmaceuticals media release, Otsuka, Europe and Asia Pacific partner, preparing to submit MAA for donidalorsen.

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