# FDA Approves Lipfendra as First Oral PCSK9 Inhibitor — Historic Shift in LDL Management

> fda · REPORTED · 2026-07-17

On July 17, 2026, the FDA approved Merck's Lipfendra (enlicitide) as the first oral PCSK9 inhibitor, offering a once-daily pill alternative to injectable therapies such as Repatha and Praluent for patients with high LDL cholesterol. Phase 3 CORALreef trials demonstrated LDL-C reductions of 56–59% versus placebo.

About Merck & Co. (Lipfendra): Merck & Co. is a global pharmaceutical company that discovers and markets medicines across cardiovascular, oncology, and infectious disease therapeutic areas, including blockbuster therapies such as Keytruda and now Lipfendra.

- Company: Merck & Co. (Lipfendra)
- Sector: cardiology
- Primary source: https://www.drugtopics.com/view/fda-approves-first-oral-pcsk9-inhibitor-to-lower-ldl-cholesterol

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