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FDA Medication Tracker

← All approvals · Weight loss & diabetes · 2024

Tryngolza (olezarsen)

The FDA approved Tryngolza (olezarsen) on December 19, 2024 to treat familial chylomicronemia syndrome.
Brand name
Tryngolza
Generic name
olezarsen
FDA approval date
December 19, 2024
Approved use (FDA wording)
To treat familial chylomicronemia syndrome
Company
Ionis Pharms Inc.
Application
NDA218614
Dosage form / route
SOLUTION · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Weight loss & diabetes

Indications and usage, from the FDA label

TRYNGOLZA ® is indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). TRYNGOLZA is an apolipoprotein C-III (apoC-III)-directed antisense oligonucleotide (ASO) indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). ( 1 ) To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). ( 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.