LIPFENDRA (Enlicitide) Tablets

LIPFENDRA (enlicitide), from Merck (MSD), is an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

Enlicitide is a macrocyclic peptide that binds PCSK9 and inhibits its interaction with LDL receptors. It is the first PCSK9 inhibitor taken by mouth, as a once-daily tablet. In two placebo-controlled Phase 3 trials (CORALreef Lipids and CORALreef HeFH) in 3,207 adults already on maximally tolerated statin therapy, LIPFENDRA lowered LDL-C by a placebo-adjusted 56% and 59% at Week 24.

• In the CORALreef HeFH trial, the adverse reactions that occurred more often than with placebo were diarrhea (7% vs 2%) and dizziness (9% vs 4%).
• In the CORALreef Lipids trial, the frequency of adverse reactions was similar to placebo, and similar proportions of patients discontinued treatment because of an adverse reaction.
• It is not yet known whether LIPFENDRA reduces the risk of cardiovascular morbidity and mortality; a cardiovascular outcomes trial is ongoing.
• LIPFENDRA is used as an adjunct to diet and exercise; the trial participants were already taking maximally tolerated statin therapy.
• Review the full prescribing information for complete contraindications, warnings, and drug interactions before starting treatment.

What documents are required to import LIPFENDRA to India?

LIPFENDRA may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered physician
• Lipid profile / diagnostic report confirming hypercholesterolemia
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is LIPFENDRA available in India?

LIPFENDRA was approved in the US in July 2026 and may not yet be commercially available in India. It can be legally accessed through the Named Patient Program (NPP).

Indian Pharma Network (IPN) can source LIPFENDRA from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For LIPFENDRA cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: Approved by the FDA — July 2026 (Priority Review).

What is LIPFENDRA used for?

LIPFENDRA lowers LDL (“bad”) cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, alongside diet and exercise.

Who manufactures LIPFENDRA?

LIPFENDRA is manufactured by Merck Sharp & Dohme LLC (Merck, known as MSD outside the US and Canada).

How is LIPFENDRA taken?

It is a 20 mg tablet taken by mouth once daily.

How does LIPFENDRA differ from injectable PCSK9 inhibitors?

LIPFENDRA is the first PCSK9 inhibitor approved as a once-daily tablet; earlier PCSK9 inhibitors were available only as injections.

How much does LIPFENDRA cost in India?

Cost depends on treatment duration and sourcing logistics — share your prescription with IPN for a quote.