Enlicitide
Also referenced as: Lipfendra, MK-0616
An oral macrocyclic peptide targeting PCSK9 for LDL-cholesterol lowering.
- Evidence grade
- BModerate Human Evidence
Moderate Human Evidence
- Regulatory status
- FDA Approved for Specific Indication
Lipfendra received FDA approval in July 2026 as an adjunct to diet and exercise to lower LDL-C in adults with hypercholesterolemia, including HeFH.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
An oral macrocyclic peptide targeting PCSK9 for LDL-cholesterol lowering.
Lipfendra received FDA approval in July 2026 as an adjunct to diet and exercise to lower LDL-C in adults with hypercholesterolemia, including HeFH.
An LDL biomarker reduction is not yet proof that this particular medicine reduces heart attacks or mortality.
Why It's Being Studied
- Hypercholesterolemia
- PCSK9 inhibition
- LDL cholesterol
Mechanism of Action
Blocking PCSK9 interaction with LDL receptors helps preserve receptors that remove LDL cholesterol from circulation.
Blocking PCSK9 interaction with LDL receptors helps preserve receptors that remove LDL cholesterol from circulation. An LDL biomarker reduction is not yet proof that this particular medicine reduces heart attacks or mortality.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- Hypercholesterolemia
- PCSK9 inhibition
- LDL cholesterol
- Oral approved medicine
Evidence Summary
CORALreef studies support substantial LDL-C reduction; an enlicitide-specific cardiovascular-event benefit should not be presumed.
Higher tiers carry more weight. Filled tiers have evidence for Enlicitide; tap to read it.
- CORALreef studies support substantial LDL-C reduction; an enlicitide-specific cardiovascular-event benefit should not be presumed.
1 cited sources.
- Prescribing label1
Human clinical evidence
- CORALreef studies support substantial LDL-C reduction; an enlicitide-specific cardiovascular-event benefit should not be presumed.
Reported Adverse Events in Research
- Diarrhea and dizziness were reported in the HeFH studies; the complete label defines other safety and interaction considerations.
Limitations of Current Evidence
- An LDL biomarker reduction is not yet proof that this particular medicine reduces heart attacks or mortality.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Enlicitide | Trofinetide | |
|---|---|---|
| Evidence grade | B — Moderate Human Evidence | B — Moderate Human Evidence |
| Regulatory status | FDA Approved for Specific Indication | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Oral approved medicine | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Prescribing label
Enlicitide — prescribing label