Donidalorsen Sodium 80 mg/0.8 mL Suppliers & Bulk Manufacturers

Available Forms: Injection (Autoinjector)

Available Strengths: 80 mg/0.8 mL

Reference Brands: Dawnzera (USA)

Category: Immune Disorder

Donidalorsen is an RNA-targeted antisense oligonucleotide medication used to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. It works by reducing production of plasma prekallikrein (PKK), a key protein in the pathway that triggers swelling episodes. Administered via subcutaneous injection every 4 or 8 weeks, Dawnzera significantly lowers the frequency of HAE attacks.

Product Description:

Donidalorsen is an antisense oligonucleotide that targets the messenger RNA for prekallikrein in liver cells, reducing how much of that protein is made. Prekallikrein is the precursor of plasma kallikrein, the enzyme that generates bradykinin — the mediator responsible for the swelling attacks of hereditary angioedema. Lowering the precursor lowers the whole downstream cascade.

It is used to prevent attacks in hereditary angioedema in patients aged twelve and over, given as a subcutaneous injection every four or eight weeks depending on response. In trials it reduced monthly attack rates by around ninety percent, with many patients becoming attack-free. It is a preventive: patients still need an on-demand treatment for breakthrough attacks. Injection site reactions are the commonest adverse effect. Because the mechanism reduces a specific liver protein rather than suppressing immunity broadly, infection risk is not a feature of its profile.

Sourcing notes. Originator product approved in 2025, on patent, no generic. Supplied in an autoinjector for home use after training. Cold chain, with a defined room-temperature period. It competes with an anti-kallikrein antibody and an anti-factor XIIa antibody in the same prophylaxis market, so the argument is dosing interval and route rather than mechanism alone.