Donidalorsen clinical trials
Also written ISIS 721744.
How each study uses donidalorsen is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- 21 Aug 2025 · DAWNZERA (AUTOINJECTOR) · NDA 219407 (FDA, Drugs@FDA)
- European Union
- 19 Jan 2026 · Dawnzera · EMEA/H/C/006554 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
7 studies that test it; most in 2020 (3)
| Year | Studies |
|---|---|
| 2017 | 1 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2026 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 6 · Other 1
Ionis Pharmaceuticals, Inc. (6) · Hospital do Coracao (1)
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 1, 1 in phase 3
Studies that test donidalorsen, phase 3 first.
- Dec 2026A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)Phase 3 · Ionis Pharmaceuticals, Inc.
Studies
Open first, then newest update. How each study uses donidalorsen is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 7
- Donidalorsen Treatment in Children With Hereditary AngioedemaRecruitingPhase 3Ionis Pharmaceuticals, Inc.NCT07298447Written as Donidalorsen
- An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary AngioedemaCompletedPhase 2Ionis Pharmaceuticals, Inc.NCT04307381Written as Donidalorsen
- A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)Active, not recruitingPhase 3Ionis Pharmaceuticals, Inc.NCT05392114Written as Donidalorsen
- OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)CompletedPhase 3Ionis Pharmaceuticals, Inc.NCT05139810Written as Donidalorsen
- A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary AngioedemaCompletedPhase 2Ionis Pharmaceuticals, Inc.NCT04030598Written as Donidalorsen
- Antisense Therapy to Block the Kallikrein-kinin Pathway in COVID-19CompletedPhase 2Hospital do CoracaoNCT04549922Written as ISIS 721744
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy VolunteersCompletedPhase 1Ionis Pharmaceuticals, Inc.NCT03263507Written as Donidalorsen
Codes
What other systems call donidalorsen · ClinicalTrials.gg INT001958
- MeSH (NLM) C000723381donidalorsenConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) ZD4D8M32TLDONIDALORSENConfirmed FDA, NLM
- NCI Thesaurus C177101DonidalorsenOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000723381 | donidalorsen | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | ZD4D8M32TL | DONIDALORSEN | Confirmed FDA, NLM |
| NCI Thesaurus | C177101 | Donidalorsen | One source FDA |
Also registered as donidalorsen sodium (UNII Y30VEG5PH1).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.