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Hamdy Alkady: FDA Approves the First Oral PCSK9 Inhibitor
Hamdy Alkady/LinkedIn
Aug 9, 2026, 07:54

Hamdy Alkady: FDA Approves the First Oral PCSK9 Inhibitor

Hamdy Alkady, Consultant Endocrinologist at King Fahad Armed Forces Hospital, shared a post on LinkedIn about recent articles, adding:

“A New Era in Lipid Management Begins

The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, marking a major milestone in the treatment of hypercholesterolemia.

For years, PCSK9 inhibition has required injectable monoclonal antibodies.

Enlicitide now introduces a once-daily oral alternative, potentially expanding treatment options for patients who need substantial LDL-C reduction but prefer to avoid injections.

Key highlights from the Phase 3 CORALreef program:

LDL-C reduction of approximately 56–59% on top of background lipid-lowering therapy.

Significant reductions in:

  • Non-HDL cholesterol
  • Apolipoprotein B
  • Lipoprotein(a)

Safety profile generally comparable to placebo, with mostly mild gastrointestinal adverse events.

What does this mean clinically?

This approval represents an important advance for patients with:

However, it is important to note that approval is based on LDL-C lowering rather than cardiovascular outcomes.

The ongoing CORALreef Outcomes trial will determine whether enlicitide reduces myocardial infarction, stroke, and cardiovascular death.

If outcome benefits are confirmed, oral PCSK9 inhibition may become one of the most important developments in preventive cardiology over the coming years.

The era of injectable-only PCSK9 inhibition has officially expanded to include an oral option.”

Title: A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide

Authors: Ann Marie Navar, Elina Mikhailova, Alberico L Catapano, Puja Banka, Dirk J Blom, Alberto Cadena, Susan Kourpanidis, Norman E Lepor, Kazuhisa Tsukamoto, Geraldine Mendizabal, Julio Nunez, Wenjuan Zhang, Pengfei Zhu, Min Zhuo, Christie M Ballantyne

Hamdy Alkady: FDA Approves the First Oral PCSK9 Inhibitor

Title: Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial

Authors: Alberico L. Catapano, Elina Mikhailova, Ann Marie Navar, Puja Banka, Pablo Corral, Manish Saxena, P. Gabriel Steg, Subodh Verma, Andrew Yacoub Kordahi, Geraldine Mendizabal, Pengfei Zhu, Christie M. Ballantyne

Hamdy Alkady: FDA Approves the First Oral PCSK9 Inhibitor

Title: Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial

Authors: Christie M. Ballantyne, Laura Gellis, Jean-Claude Tardif, Puja Banka, Ann Marie Navar, Emil Andreas Asprusten, Russell Scott, Erik S. G. Stroes, Samar Froman, Geraldine Mendizabal, Fan Wang, Alberico L. Catapano

Hamdy Alkady: FDA Approves the First Oral PCSK9 Inhibitor

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Alberico L Catapano Alberto Cadena Andrew Yacoub Kordahi Ann Marie Navar Christie M. Ballantyne Dirk J. Blom Elina Mikhailova Emil Andreas Asprusten enlicitide Erik S. G. Stroes Fan Wang Geraldine Mendizabal Hamdy Alkady Health Hematology Hemostasis Hemostasis News Hemostasis Today Hypercholesterolemia Jean-Claude Tardif Julio Nunez Kazuhisa Tsukamoto Laura Gellis LDL-C Manish Saxena Medicine Min Zhuo Norman E. Lepor P. Gabriel Steg Pablo Corral PCSK9 inhibitor Pengfei Zhu Puja Banka Russell Scott Samar Froman Subodh Verma Susan Kourpanidis Wenjuan Zhang
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