Donidalorsen 80mg/0.8ml solution for injection pre-filled disposable devices
Requires a prescription from a doctor or prescriber
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Safety monitoring data
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
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Suspected adverse reactions reported for Donidalorsen
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1 branded products available
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Dawnzera 80mg/0.8ml solution for injection pre-filled pens
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
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Codes for healthcare professionals and prescribing systems
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NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
5 hours
Mechanism
Donidalorsen is a prekallikrein-directed antisense oligonucleotide (ASO) which i…
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
2 hours
Half-life
1 month
[L53788]
…
Protein binding
98%
[L53788]
Volume of distribution
69.8 L
[L53788]
Metabolism
Elimination
1%
[L53788]
…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Donidalorsen was approved by the FDA in August 2025 for prophylactic use to prevent HAE attacks.[L53783][L53788] It is the first RNA-targeted therapy approved for HAE.[L53783]
[L53788]
[L53788]
In patients with HAE, C1-inhibitor deficiency or dysfunction leads to excessive plasma kallikrein activity and bradykinin generation, which causes angioedema attacks.[L53788] By lowering PKK concentration, donidalorsen prevents excessive kallikrein-induced bradykinin production in patients with HAE.[L53788]
In the OASIS-HAE trial, a decrease in plasma PKK concentrations was observed as early as Week 4, with a mean percentage reduction from baseline of 48% across both treatment groups.[L53788] Because endogenous prekallikrein in circulation requires 25 to 30 days to degrade, the full clinical effect of donidalorsen is typically achieved within this timeframe.[A274298] By Week 24, trough plasma PKK concentrations indicated reductions of 73% and 47% following treatment with donidalorsen 80 mg every 4 weeks and every 8 weeks, respectively.[L53788]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L53788]
The geometric mean for the steady-state maximum plasma concentration (Cmax,ss) was 417 ng/mL for the 80 mg every 4 weeks dosing regimen and 416 ng/mL for the 80 mg every 8 weeks regimen.
[L53788]
The total drug exposure over the dosing interval at steady-state (AUCt,ss) was also similar between the two schedules, with a geometric mean of 5240 ng·h/mL for the 80 mg every 4 weeks regimen and 5210 ng·h/mL for the 80 mg every 8 weeks regimen.
[L53788]
[L53788]
The half-life of the initial rapid clearance phase, reflecting tissue distribution, is approximately 5 hours.
[L53788]
[L53788]
[L53788]
[L53788]
The linker that covalently connects the ASO to the GalNAc residues is cleaved via hydrolysis, undergoing dephosphorylation and subsequent oxidative metabolism to form inactive metabolites, which are minimally released in circulation.
[L53788]
The most abundant linker-related metabolite (M8) is a substrate of CYP3A4.
[L53788]
[L53788]
The renal route of elimination is similarly minor for linker-related metabolites.
[L53788]
Proteins and enzymes this drug interacts with in the body
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Donidalorsen
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72