DAWNZERA (AUTOINJECTOR)

LaunchRNA

donidalorsen

NDASUBCUTANEOUSSOLUTION
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
7

Mechanism of Action

ASO‑GalNAc conjugate that causes ribonuclease H1 (RNase H1)‑mediated degradation of PKK mRNA through binding to PKK mRNA, which results in reduced production of PKK protein. PKK is a pro‑enzyme for plasma kallikrein, which results in the release of bradykinin, a potent vasodilator causing swelling…

Clinical Trials (5)

NCT07298447Phase 3Not Yet Recruiting

Donidalorsen Treatment in Children With Hereditary Angioedema

Started Jan 2026
20 enrolled
Hereditary Angioedema (HAE)
NCT05392114Phase 3Active Not Recruiting

A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)

Started Jul 2022
154 enrolled
Hereditary Angioedema
NCT05139810Phase 3Completed

OASIS-HAE: A Study to Evaluate the Safety and Efficacy of Donidalorsen (ISIS 721744 or IONIS-PKK-LRx) in Participants With Hereditary Angioedema (HAE)

Started Dec 2021
91 enrolled
Hereditary Angioedema
NCT04307381Phase 2Completed

An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema

Started Apr 2020
20 enrolled
Hereditary Angioedema
NCT04030598Phase 2Completed

A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema

Started Jan 2020
23 enrolled
Hereditary Angioedema

Loss of Exclusivity

LOE Date
May 1, 2035
111 months away
Patent Expiry
May 1, 2035

Patent Records (5)

Patent #ExpiryTypeUse Code
9315811
Oct 21, 2032
U-3010
9127276
May 1, 2034
Substance
9181549
May 1, 2034
Substance
9670492
Aug 28, 2034
Substance
10294477
May 1, 2035
SubstanceProduct
U-3010