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Donidalorsen

DRUG7 trials

Sponsors

Ionis Pharmaceuticals, Inc.

Conditions

Healthy VolunteersHereditary AngioedemaHereditary Angioedema (HAE)

Phase 1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy Volunteers
CompletedNCT03263507
Ionis Pharmaceuticals, Inc.Healthy Volunteers
Start: 2017-08-28End: 2018-10-09Updated: 2022-08-04

Phase 2

A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema
CompletedNCT04030598
Ionis Pharmaceuticals, Inc.Hereditary Angioedema
Start: 2020-01-07End: 2021-03-01Updated: 2023-04-03
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema
CompletedNCT04307381
Ionis Pharmaceuticals, Inc.Hereditary Angioedema
Start: 2020-03-31End: 2025-01-24Updated: 2026-05-08

Phase 3

OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)
CompletedNCT05139810
Ionis Pharmaceuticals, Inc.Hereditary Angioedema
Start: 2021-12-03End: 2023-11-09Updated: 2025-03-06
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
Active, not recruitingNCT05392114
Ionis Pharmaceuticals, Inc.Hereditary Angioedema
Start: 2022-07-13End: 2027-03-31Updated: 2025-12-12
Donidalorsen Treatment in Children With Hereditary Angioedema
RecruitingNCT07298447
Ionis Pharmaceuticals, Inc.Hereditary Angioedema (HAE)
Start: 2026-04-21End: 2029-06-01Target: 20Updated: 2026-09-02

Unknown Phase

Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema
NCT06415448
Ionis Pharmaceuticals, Inc.Hereditary Angioedema
Updated: 2026-09-04

Related Papers

Psychometric validation of the Angioedema Quality of Life Questionnaire (AE-QoL) for hereditary angioedema
Journal of Patient-Reported Outcomes2026-06-19
Switching Long-Term Prophylaxis to Donidalorsen for Hereditary Angioedema: 1-Year OASISplus Results.
2026-03-14
Association Between the Angioedema Control Test and Attack Frequency in Hereditary Angioedema.
2026-01-01
Exposure-Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema.
2025-11-011 citations
Donidalorsen Treatment of Hereditary Angioedema in Patients Previously on Long-Term Prophylaxis.
2025-07-17
Patient‐Reported Outcomes in the Phase III OASIS‐HAE Study of Donidalorsen for Hereditary Angioedema
Allergy2025-04-193 citations
Efficacy and Safety of Donidalorsen for Hereditary Angioedema
New England Journal of Medicine2024-05-3143 citations
A phase 2 <scp>open‐label</scp> extension study of prekallikrein inhibition with donidalorsen for hereditary angioedema
Allergy2023-11-2716 citations
Inhibition of Prekallikrein for Hereditary Angioedema
New England Journal of Medicine2022-03-1664 citations