# FDA Approves Lipfendra (Enlicitide), First-Ever Oral PCSK9 Inhibitor for High Cholesterol

> fda · REPORTED · 2026-07-17

The FDA on July 17, 2026 approved Lipfendra (enlicitide), Merck's once-daily oral PCSK9 inhibitor, for adults with hypercholesterolemia including heterozygous familial hypercholesterolemia — the first oral therapy in a class previously limited to injectables. Two pivotal Phase 3 CORALreef trials showed placebo-adjusted LDL-C reductions of 56% and 59% at week 24.

About Merck & Co.: Merck & Co. is a global pharmaceutical company that discovers, develops, and commercializes medicines and vaccines across a broad range of therapeutic areas including cardiovascular disease, oncology, and infectious disease.

- Company: Merck & Co.
- Sector: cardiology
- Primary source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.