Enlicitide (Lipfendra): how it works, status and trials

Approved Jul 2026; outcome trial ongoingPillLowering LDL cholesterol

Enlicitide (Lipfendra) is a daily pill, taken fasting, that binds PCSK9 and keeps it from attaching to the LDL receptor.

In technical terms: Binds PCSK9 and blocks its interaction with the LDL receptor.

The highlighted badge marks where Enlicitide (Lipfendra) acts. Open the full map or compare every therapy.

At a glance

Acts on: PCSK9 protein
How it is given: Oral macrocyclic peptide · daily, fasting
What the main trial found: LDL-C −55.8 pp at 24 weeks (CORALreef Lipids)
Status (curated October 25, 2026): Approved Jul 2026; outcome trial ongoing

Where it fits in the body

The LDL-receptor cycle

LDL particles are cleared from blood when they bind LDL receptors on liver cells. After the particle is taken in, a receptor normally returns to the surface and can be reused many times. PCSK9 escorts the receptor to the lysosome, where it is destroyed. Every PCSK9-pathway drug (5–10) works by keeping more receptors on the surface.

See it on the interactive map

Trials and registry status

From ClinicalTrials.gov, PubMed and openFDA, refreshed monthly. Last run October 27, 2026.

Enlicitide (Lipfendra) from Merck

Stage: US approved 2026-07-15. 8 active of 34 registered trials. 3 new papers in the last 31 days.

NCT06008756 (NCT06008756): active not recruiting, primary completion 2029-11-29

Recent changes

October 25, 2026: PMID 42870623: Enlicitide: The First Oral PCSK9i for Lowering Low-Density Lipoprotein Cholesterol.
October 25, 2026: PMID 42867105: Efficacy and Safety of Enlicitide in Hypercholesterolemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Evidence

CORALreef Lipids (PubMed 41879224)

Common questions

How does Enlicitide (Lipfendra) work?

Enlicitide (Lipfendra) is a daily pill, taken fasting, that binds PCSK9 and keeps it from attaching to the LDL receptor. In technical terms: Binds PCSK9 and blocks its interaction with the LDL receptor. It acts on PCSK9 protein.

How much does Enlicitide (Lipfendra) lower cholesterol or other lipids?

LDL-C −55.8 pp at 24 weeks (CORALreef Lipids). Individual results differ, and a clinician can say what to expect for one person.

Is Enlicitide (Lipfendra) approved, and what is the status?

Approved Jul 2026; outcome trial ongoing (curated October 25, 2026). Registry stage as of October 27, 2026: Enlicitide, US approved 2026-07-15.

How is Enlicitide (Lipfendra) taken?

Oral macrocyclic peptide · daily, fasting.

Lipfendra (Enlicitide): The Oral PCSK9 Pill

Related therapies

Statins: Approved (generic)
Bempedoic acid (Nexletol, Nexlizet): Approved 2020
Ezetimibe (Zetia): Approved (generic)
Bile acid sequestrants (colesevelam): Approved (generic)

Educational, not medical advice. Mechanism and status text curated October 25, 2026; registry data refreshed October 27, 2026. Registries can lag company announcements. Effects are placebo-adjusted results from the main published trial, not head-to-head comparisons. Investigational agents are available only in clinical trials. Preval Health does not practice medicine; licensed clinicians in a partner network provide care. If you have chest pain or signs of a stroke, call 911.