Independent reference. Not affiliated with, endorsed by, or speaking for the U.S. Food and Drug Administration.
FDA Medication Tracker

← All approvals · Heart & blood · 2025

Lerochol (lerodalcibep-liga)

The FDA approved Lerochol (lerodalcibep-liga) on December 12, 2025 to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and exercise.
Brand name
Lerochol
Generic name
lerodalcibep-liga
FDA approval date
December 12, 2025
Approved use (FDA wording)
To reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and exercise
Company
Lib Therapeutics, Inc..
Application
BLA761427
Dosage form / route
INJECTABLE · INJECTION
Boxed warning on label
Not listed
Category on this site
Heart & blood

Indications and usage, from the FDA label

LEROCHOL TM 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). LEROCHOL 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). ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.