Merck Reports Pivotal PCSK9 Pill Data in Race to Beat AstraZeneca to Market
Merck presented pivotal Phase 3 data for its oral PCSK9 inhibitor, enlicitide, at AHA 2025, showing LDL-C reductions of 55.8% to 59.7% compared to placebo.
Enlicitide demonstrated a safety profile comparable to placebo, with low discontinuation rates due to adverse events.
The drug is positioned as the first oral PCSK9 inhibitor, offering significant convenience over injectable alternatives.
Merck's results come amid a race to market ahead of AstraZeneca's similar oral PCSK9 candidate.
Analysts highlight enlicitide's potential for rapid adoption due to oral administration, room-temperature storage, and likely lower pricing compared to injectables.
If approved, enlicitide could transform cholesterol management, especially for patients hesitant about injections or unable to tolerate statins.