Newly approved pill cuts LDL cholesterol levels by more than half
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- Reviewed by Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing
A new pill that dramatically lowers harmful LDL cholesterol may be a good option for people who can’t tolerate statins or who haven’t lowered their LDL enough despite their current treatment with cholesterol-lowering drugs.
Approved by the FDA in July 2026, enlicitide (Lipfendra) is the first oral version of a class of drugs known as PCSK9 inhibitors. These drugs work by mimicking the effect of a naturally occurring variant in the PCSK9 gene that leads to very low LDL levels. But the original drugs — which are given by injection once or twice a month — aren’t widely used. Some people aren’t comfortable giving themselves an injection. Also, most insurance companies won’t cover the cost (which range from $200 to $500 or more per month) until a person has tried other therapies without success.
Enlicitide is a daily pill that must be taken on an empty stomach with a sip of water, black coffee, or plain tea. It lowers LDL by nearly 60%, which is similar to the injectable PCSK9 drugs. Less than 10% of users experienced either dizziness or diarrhea, the two most common side effects. A month’s supply will cost about $300; for now, insurance coverage remains unclear.
The drug might be especially helpful for people whose LDL remains above recommended levels, despite taking cholesterol-lowering drug such as statins. The 2026 cholesterol guidelines recommend that people who’ve had a heart attack or stroke should aim for an LDL cholesterol of less than 55 milligrams per deciliter.
The injectable PCSK9 drugs, alirocumab (Praluent) and evolocumab (Repatha), have been shown to reduce the incidence of heart attacks, strokes, and death from cardiovascular disease by up to 20% among people at high risk, over periods of up to at least five years. A similar study is currently underway to see if enlicitide offers the same benefit, with results expected in several years.
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About the Author
Julie Corliss, Executive Editor, Harvard Heart Letter
About the Reviewer
Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing
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