Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema

Available (expanded access)

Conditions studied: Hereditary Angioedema

In brief

The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.

Key facts

Study ID

NCT06415448

Run by

Ionis Pharmaceuticals, Inc.

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients in the ISIS 721744-CS3 (Open-Label Extension [OLE] Study) who have completed 205 weeks of treatment.
• Female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity.

You may not qualify if…

• Any patient who is pregnant or plans to become pregnant.
• Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment.

Full record on ClinicalTrials.gov

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