Lipfendra (enlicitide decanoate) is filed as oral PCSK9 inhibitor. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. LIPFENDRA is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy. ( 1 )
12.1 Mechanism of Action Enlicitide is a macrocyclic peptide that binds to PCSK9. PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, enlicitide increases the number of LDLRs available to clear LDL-C, thereby lowering LDL-C levels.
4 CONTRAINDICATIONS None. None. ( 4 )
Dizziness (9%); Diarrhea (7%)
6 ADVERSE REACTIONS The frequencies of adverse reactions in adults with hypercholesterolemia were similar between those treated with LIPFENDRA and those receiving placebo. The most common adverse reactions in a study of adults with HeFH treated with LIPFENDRA were diarrhea and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Hypercholesterolemia The safety of LIPFENDRA was evaluated in Trial 1 (CORALreef Lipids, NCT05952856), a 52-week, multicenter, double-blind, randomized, placebo-controlled trial in 2,904 patients with hypercholesterolemia (including those with and without HeFH) and a history of a major atherosclerotic cardiovascular disease (ASCVD) event or increased risk for development of a first major ASCVD event [see Clinical Studies (14) ] . In Trial 1, the frequencies of adverse reactions in adults with hypercholesterolemia were similar between those treated with LIPFENDRA and those receiving placebo. Similar proportions of LIPFENDRA-treated patients and placebo-treated patients discontinued treatment because of an adverse reaction. Adverse Reactions in Adults with HeFH The safety of LIPFENDRA was evaluated in Trial 2 (CORALreef HeFH, NCT05952869), a 52-week multicenter, double-blind, randomized, placebo-controlled trial in 303 patients with HeFH [see Clinical Studies (14) ] . In Trial 2, the most common adverse reactions in adults with HeFH treated with LIPFENDRA that occurred at higher frequencies compared to placebo were diarrhea (LIPFENDRA 7%, placebo 2%) and dizziness (LIPFENDRA 9%, placebo 4%). Similar proportions of LIPFENDRA-treated patients and placebo-treated patients discontinued treatment because of an adverse reaction. The safety profile observed in adults with HeFH in Trial 2 was otherwise generally consistent with that observed in adults with hypercholesterolemia in Trial 1.
2 DOSAGE AND ADMINISTRATION The recommended dosage of LIPFENDRA is one 20 mg tablet taken orally once daily. ( 2.1 ) Take LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea. ( 2.2 ) Swallow the tablet whole. Do not split, crush, or chew the tablet. ( 2.2 ) After taking LIPFENDRA, wait at least 30 minutes before eating food or drinking beverages other than water, black coffee, or plain tea. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of LIPFENDRA is one 20 mg tablet taken orally once daily. Assess LDL-C when clinically appropriate. The LDL-C-lowering effect of LIPFENDRA may be measured as early as 4 weeks after initiation. 2.2 Important Administration Instructions Take LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea. Swallow the tablet whole. Do not split, crush, or chew the tablet. After taking LIPFENDRA, wait at least 30 minutes before eating food or drinking beverages other than water, black coffee, or plain tea [see Clinical Pharmacology (12.3) ] . LIPFENDRA can be taken with other medications [see Clinical Pharmacology (12.3) ] . If a dose is missed, take the missed dose as soon as possible, at least 30 minutes before the next food or drink (other than water, black coffee, or plain tea). Do not take 2 doses on the same day.
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Dosage and Administration Instruct patients to take their dose of LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea and to wait at least 30 minutes before their next food or beverage (other than water, black coffee, or plain tea). Each tablet should be swallowed whole [see Dosage and Administration (2.2) ] . LIPFENDRA can be taken with other medications [see Clinical Pharmacology (12.3) ] . Missed Doses Advise the patient that if a dose is missed, they should take the missed dose as soon as possible, at least 30 minutes before the next food or drink (other than water, black coffee, or plain tea). They should not take 2 doses on the same day [see Dosage and Administration (2.2) ] .
According to its FDA label, Lipfendra (enlicitide decanoate) is approved for: 1 INDICATIONS AND USAGE LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstr… For medical advice, please talk to your prescriber or pharmacist.
Lipfendra (enlicitide decanoate) belongs to the oral PCSK9 inhibitor class of medications.
The FDA label lists Lipfendra (enlicitide decanoate) as: 3 DOSAGE FORMS AND STRENGTHS Tablets: 20 mg enlicitide, white to off-white with grey specks, oval-shaped, film-coated, debossed with “119” on one side and the corporate logo on the other side Film-Coated Tablets: 20 mg enlicitide ( 3 ); oral route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Lipfendra. Availability changes as patents expire.
Our ingest of the FDA label for Lipfendra (enlicitide decanoate) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Lipfendra (enlicitide decanoate) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Lipfendra (enlicitide decanoate) as 2026-07-15.
The FDA label lists Merck Sharp & Dohme LLC as a labeler/manufacturer of Lipfendra (enlicitide decanoate). Multiple firms may market generics of the same molecule.
The FDA label states: "Store LIPFENDRA at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store and dispense LIPFENDRA in the original bottle and keep the bottle tigh…" Follow the packaging insert for the authoritative guidance.
Loading full data from Know Your Drugs Institute…