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Lerodalcibep Injection 300 mg/1.2 mL Suppliers & Bulk Manufacturers

Available Forms: Pre-filled syringe, autoinjector (subcutaneous)

Available Strengths: 300 mg/1.2 mL

Reference Brands: Lerochol (LIB Therapeutics)

Category: Heart Disorder

Lerodalcibep (Lerochol, LIB Therapeutics) is a once-monthly PCSK9-blocking injection that lowers LDL cholesterol, approved by the US FDA in December 2025. 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:

Lerodalcibep is a biologic PCSK9 inhibitor. Like evolocumab and alirocumab it stops PCSK9 from destroying LDL receptors in the liver, so more LDL cholesterol is cleared from the blood. It is built differently from those antibodies and stays in the body longer, so it is given once a month as a single 300 mg injection under the skin.

The US FDA approved lerodalcibep as Lerochol in December 2025 to lower LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, usually with a statin. A pre-filled syringe came first and an autoinjector was added in August 2026.

Sourcing and licensing notes. Lerodalcibep is patented and there is no biosimilar. Other PCSK9 options on PharmaTradz include evolocumab, inclisiran and the new oral enlicitide. We confirm registration status for each destination before quoting.

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

Where lerodalcibep is approved

Checked 3 Oct 2026
MarketStatusBrand · regulator · date
United States Approved Lerochol · FDA · Dec 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 LDL cholesterol in adults with high cholesterol, including heterozygous familial hypercholesterolaemia.

Lerochol, from LIB Therapeutics. The US FDA approved it in December 2025.

Once a month, as a single 300 mg injection under the skin.

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

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