Tryngolza FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 31, 2024.
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.
- Tryngolza is an RNA-targeted LIgand Conjugated Antisense (LICA) medicine that works to regulate triglyceride metabolism by reducing serum apoC-III protein, which leads to increased clearance of plasma triglycerides and VLDL.
- FDA approval was based on results of the Phase 3 Balance study in which Tryngolza demonstrated a statistically significant placebo-adjusted mean reduction in triglyceride levels of 42.5% from baseline to six months, and 57% from baseline to 12 months.
- Tryngolza is administered by subcutaneous injection once monthly.
- Warnings and precautions associated with Tryngolza include hypersensitivity reactions.
- Common adverse reactions (incidence >5%) include injection site reactions, decreased platelet count, and arthralgia.
Development timeline for Tryngolza
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.