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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)

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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: 11 Dec 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

  • 14 Nov 2025 According to Ionis Pharmaceuticals Media Release,based on positive results from the Phase 3 OASIS-HAE and OASISplus studies,the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion of DAWNZER (donidalorsen) for the routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents (>12 years).The positive opinion is now referred to the European Commission for an approval decision, expected in Q1 2026.
  • 21 Aug 2025 According to Ionis Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved DAWNZERA (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. The approval was based on positive results from this study.
  • 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.

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