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| Market | Status | Brand · 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 →
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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