NEW JERSEY / LONDON (IT BOLTWISE) – Merck & Co. has achieved impressive results in Phase 3 trials with its new PCSK9 pill Enlicitide, showing similar reductions in LDL cholesterol as existing injections. This oral delivery could revolutionize the cholesterol therapy market.

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Merck & Co. has achieved impressive results in phase 3 trials with its new PCSK9 pill Enlicitide, showing similar reductions in LDL cholesterol as existing injections. This oral delivery could revolutionize the cholesterol therapy market. The ability to take the drug orally once daily offers a significant advantage over current injectable biologics, which are often considered cumbersome and expensive.

Previous PCSK9 inhibitors have achieved blockbuster status, but failed to meet initial expectations of a $40 billion market. Analysts at Leerink Partners said Enlicitide could gain widespread acceptance in the primary care space due to its ease of use and expected lower cost. Patients who want to avoid injections could particularly benefit from this new approach.

In the trials, Enlicitide showed an impressive 59.7% reduction in LDL-C levels compared to placebo after 24 weeks. These results were presented at the American Heart Association Scientific Sessions 2025 and highlight the drug’s potential to achieve the primary study objective. The studies included over 2,900 patients at high risk of atherosclerotic cardiovascular disease.

Another advantage of Enlicitide is that it can be stored at room temperature, making it easier to handle compared to refrigerated injectable alternatives. Merck plans to present the data from the studies to regulatory authorities worldwide in order to achieve rapid market approval. If successful, enlicitide could play an important role in cardiovascular prevention.

However, competition in the field of PCSK9 inhibitors is growing. AstraZeneca is also working on an oral PCSK9 drug, but it is still a few years behind Enlicitide. The challenge for Merck will be to ensure compliance with dosage regulations, as the drug must be taken on an empty stomach to be fully effective.


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Merck's PCSK9 pill: A potential gamechanger in cholesterol therapy
Merck’s PCSK9 pill: A potential game changer in cholesterol therapy (Photo: DALL-E, IT BOLTWISE)

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