PCSK9 inhibitors: what they are, in plain words
Last checked: November 5, 2026. Educational only, not medical advice. PeptideX is not affiliated with any drug maker.
If your LDL cholesterol won't come down far enough on a statin, PCSK9 drugs may be one of the options your clinician raises, and there is now a tablet, not just injections.
Status box (Nov 5, 2026)
- FDA-approved PCSK9 drugs on DailyMed: Repatha (evolocumab, injection), Praluent (alirocumab, injection), Lipfendra (enlicitide, tablet). [2][3][4]
- Lipfendra (enlicitide) tablet: FDA approved, July 2026. [1][4]
- Leqvio (inclisiran) also targets PCSK9, but in a different way: it is a small interfering RNA (siRNA) that lowers how much PCSK9 liver cells make. It is an injection. [5]
- A trial pairing enlicitide with MK-7262 in adults with high lipoprotein(a) is recruiting. [6]
What is a PCSK9 inhibitor?
A prescription drug that lowers LDL ("bad") cholesterol. Your liver uses LDL receptors to pull LDL out of the blood. A protein called PCSK9 breaks those receptors down. PCSK9 inhibitors block PCSK9, so more receptors stay on duty clearing LDL. [1]
Which PCSK9 drugs are approved?
| Drug | Form | Maker (label) |
|---|---|---|
| Repatha (evolocumab) | Injection | Amgen [2] |
| Praluent (alirocumab) | Injection | Sanofi / Regeneron [3] |
| Lipfendra (enlicitide) | Tablet | Merck [4] |
| Leqvio (inclisiran) - siRNA, lowers PCSK9 production | Injection | Novartis [5] |
What is enlicitide?
Enlicitide is the drug in Lipfendra, a tablet from Merck. FDA approved it in July 2026. Its label says it is used with diet and exercise to lower LDL in adults with high cholesterol, including an inherited type called heterozygous familial hypercholesterolemia (HeFH). [1][4]
How is a PCSK9 inhibitor different from a statin?
- Statins reduce how much cholesterol your liver makes.
- PCSK9 inhibitors help the liver clear LDL already in your blood.
- In the trials FDA reviewed for Lipfendra, people were already on the most statin they could tolerate, and the tablet was added on top. [1]
What did the enlicitide trials show?
Two placebo-controlled trials in 3,207 adults on statins. At week 24, LDL fell by an average 56% and 59% versus placebo, depending on the group. [1] Individual results may vary.
What is an Lp(a) test, and how does it connect?
An Lp(a) test is a blood test for lipoprotein(a). Researchers are studying enlicitide together with another Merck drug, MK-7262, in adults with high Lp(a). That trial is recruiting; results are not out. [6] Ask your clinician whether an Lp(a) test makes sense for you.
Questions to ask your clinician
- Is my LDL at goal on my current treatment?
- Would a tablet or an injection fit me better?
- Should I get an Lp(a) test?
- Does my insurance cover a PCSK9 drug?
FAQ
What is a PCSK9 inhibitor? A prescription drug that lowers LDL cholesterol by blocking PCSK9, a protein that breaks down the liver's LDL receptors.
Which PCSK9 inhibitors are FDA approved? Repatha (evolocumab) and Praluent (alirocumab) are injections; Lipfendra (enlicitide) is a tablet approved in July 2026. Leqvio (inclisiran) is an injection that lowers PCSK9 a different way.
What is enlicitide? The drug in Lipfendra, a Merck tablet approved by FDA in July 2026 to lower LDL in adults with high cholesterol, along with diet and exercise.
How is a PCSK9 inhibitor different from a statin? Statins reduce cholesterol made by the liver; PCSK9 inhibitors help the liver clear LDL from the blood.
Is enlicitide being studied for high Lp(a)? Yes. A trial pairing enlicitide with MK-7262 in adults with high Lp(a) is recruiting (NCT07614984). Results are not out.
Sources (checked Nov 5, 2026)
- FDA press release, July 17, 2026: https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol
- DailyMed, Repatha: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e
- DailyMed, Praluent: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=446f6b5c-0dd4-44ff-9bc2-c2b41f2806b4
- DailyMed, Lipfendra (NDA220848): https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=100ec543-fbd0-44fc-b740-db9cdff39145
- DailyMed, Leqvio, sections 11 and 12.1: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6fc0afca-4513-4c35-b594-6544aee29a44
- ClinicalTrials.gov NCT07614984 (RECRUITING): https://clinicaltrials.gov/study/NCT07614984