Enlicitide Tablets 20 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 20 mg
Reference Brands: Lipfendra
Category: Heart Disorder
Enlicitide (Lipfendra, Merck/MSD) is the first PCSK9 inhibitor taken as a tablet, used to lower LDL cholesterol. The US FDA approved it in July 2026. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers, API makers and licensees preparing for patent expiry.
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Product Description:
Enlicitide decanoate blocks PCSK9, a protein that makes the liver destroy its own LDL receptors. With PCSK9 blocked, the liver keeps more receptors and clears more LDL ("bad") cholesterol from the blood. Until now this mechanism was only available as injections, either antibodies (evolocumab, alirocumab) or the siRNA inclisiran. Enlicitide is a macrocyclic peptide designed to be absorbed from the gut, so it is taken as a 20 mg tablet once a day.
The US FDA approved enlicitide as Lipfendra in July 2026 to lower LDL cholesterol in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, usually on top of a statin. It gives people who need more LDL lowering an oral option instead of regular injections.
Sourcing and licensing notes. Enlicitide is patented and made only by Merck & Co (MSD outside the US and Canada); there is no generic. We confirm registration status for each destination before quoting, handle enquiries for authorised supply of Lipfendra where it can lawfully be imported, and we connect developers and licensees interested in the oral PCSK9 class ahead of patent expiry.
How Enlicitide Tablets is supplied today, and licensing ahead of patent expiry
Where enlicitide is approved
Checked 3 Oct 2026| Market | Status | Brand · regulator · date |
|---|---|---|
| United States | Approved | Lipfendra · FDA · Jul 2026 |
| 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 inherited (heterozygous familial) hypercholesterolaemia, usually together with a statin.
Lipfendra, from Merck & Co (MSD). The US FDA approved it in July 2026.
No. It is a 20 mg tablet taken once a day, the first PCSK9 inhibitor that is not injected.
No. It is patented and only Merck makes it. We handle authorised-supply enquiries and connect developers and licensees preparing for patent expiry.
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View DetailsUsually answered within 48 hours | GMP documents shared before you commit