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Enlicitide · Lipfendra, MK-0616

Peptide · Inhibitor of PCSK9 · developed by Msd

Approved FDA, Jul 2026
MRK Developer
2 Registered trials

What is Enlicitide?

Enlicitide is a macrocyclic peptide that inhibits PCSK9, preventing its binding to low-density lipoprotein receptors (LDLR) on hepatocytes. This increases LDLR availability to clear LDL cholesterol from the blood, thereby lowering LDL-C levels in adults with hypercholesterolemia.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Lipfendra, MK-0616
Drug type
Peptide
Targets
PCSK9, LDLR (binding partner it blocks)
Mechanism
Inhibitor of PCSK9
Pathways
LDL-C clearance
Therapy area
Cardiovascular
Developer
Msd (MRK)
FDA status
Approved as Lipfendra (July 15, 2026), NDA220848 · FDA label
UNII
R7EZ772VG2

✅ FDA-approved uses

From the indications section of the FDA label (version of Jul 15, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07058077 Phase 2/3 Heterozygous Familial Hypercholesterolemia (HeFH) Recruiting MRK
NCT07614984 Phase 2 Lipoprotein(a) Recruiting MRK

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Heterozygous Familial Hypercholesterolemia (HeFH)Lipoprotein(a)

Other drugs acting on PCSK9

Evolocumab FDA approved Lerodalcibep FDA approved

More from Msd

BCG Live FDA approved Belzutifan FDA approved Berahyaluronidase Alfa FDA approved Berahyaluronidase Alfa and Pembrolizumab FDA approved Ensifentrine FDA approved Letermovir FDA approved Pembrolizumab FDA approved Probenecid FDA approved Alimatravir Phase 2 Bomedemstat Phase 2/3 Calderasib Phase 3 Favezelimab Phase 1/2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the MRK page.

Follow MRK, the company behind Enlicitide

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.