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Olezarsen Injection 80 mg/0.8 mL Suppliers & Bulk Manufacturers

Available Forms: Autoinjector (subcutaneous)

Available Strengths: 80 mg/0.8 mL

Reference Brands: Tryngolza (Ionis; Sobi outside the US)

Category: Heart Disorder

Olezarsen (Tryngolza, Ionis) is an antisense medicine that lowers triglycerides by reducing APOC3. It is approved in the US (December 2024) and EU (September 2025) for familial chylomicronaemia syndrome. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

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Product Description:

Olezarsen is an antisense oligonucleotide that binds the messenger RNA for apolipoprotein C-III (APOC3) in the liver, so less of the protein is made. APOC3 slows the clearance of triglyceride-rich particles; lowering it reduces triglycerides and, in trials, the number of pancreatitis attacks.

The US FDA approved olezarsen as Tryngolza in December 2024, and the European Commission followed in September 2025, for adults with familial chylomicronaemia syndrome (FCS) alongside diet. It is given as an 80 mg subcutaneous injection from an autoinjector. Ionis markets it in the US and Sobi outside the US. Ionis is also studying it in severe hypertriglyceridaemia, a much larger group of patients.

Sourcing and licensing notes. Olezarsen is patented and there is no generic. Plozasiran (Redemplo), an siRNA against the same target, is also listed on PharmaTradz. We confirm registration status for each destination before quoting.

How Olezarsen Injection is supplied today, and licensing ahead of patent expiry

Where olezarsen is approved

Checked 3 Oct 2026
MarketStatusBrand · regulator · date
United States Approved Tryngolza · FDA · Dec 2024
European Union Approved Tryngolza · European Commission · Sep 2025
Generic / biosimilar None None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access
Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing
A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives
Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule
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Frequently Asked Questions

Lowering triglycerides in adults with familial chylomicronaemia syndrome (FCS), alongside a low-fat diet.

Tryngolza, from Ionis (Sobi outside the US). Approved in the US in December 2024 and in the EU in September 2025.

Both lower APOC3. Olezarsen is an antisense oligonucleotide; plozasiran is an siRNA given every three months.

No. It is patented. We handle authorised-supply enquiries and connect developers and licensees preparing for patent expiry.

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