Tryngolza FDA Approval History

FDA Approved: Yes (First approved December 19, 2024)
Brand name: Tryngolza
Generic name: olezarsen
Dosage form: Injection
Company: Ionis Pharmaceuticals, Inc.
Treatment for: Familial Chylomicronemia Syndrome

Tryngolza (olezarsen) is an APOC-III-directed antisense oligonucleotide indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.

Familial chylomicronemia syndrome (FCS) is a rare, genetic disease caused by impaired function of the enzyme lipoprotein lipase (LPL). It is characterized by extremely elevated triglyceride levels.
Olezarsen is an RNA-targeted LIgand Conjugated Antisense (LICA) medicine designed to regulate triglyceride metabolism in the blood by lowering the body's production of apoC-III, a protein produced in the liver.
The U.S. Food and Drug Administration (FDA) granted olezarsen Fast Track designation for the treatment of FCS in January 2023, and Orphan Drug designation and Breakthrough Therapy designation in February 2024.

Development timeline for Tryngolza

Date	Article
Dec 19, 2024	Approval FDA Approves Tryngolza (olezarsen) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome
Jun 25, 2024	Ionis Announces Olezarsen New Drug Application Accepted for Priority Review and Enrollment in Phase 3 sHTG Program Completed
Apr 7, 2024	Ionis Presents Positive Results from Phase 3 Balance Study of Olezarsen for Familial Chylomicronemia Syndrome
Jan 31, 2023	Ionis Receives FDA Fast Track Designation for Olezarsen in Patients with Familial Chylomicronemia Syndrome
Nov 2, 2021	Ionis Initiates Pivotal Phase 3 Clinical Study of Olezarsen in Patients with Severe Hypertriglyceridemia

Further information

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