Prescription medicine
Olezarsen Brand names: Tryngolza; first approved as Tryngolza (Autoinjector)
Olezarsen (Tryngolza) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the olezarsen FDA label on DailyMed (effective July 3, 2026, Ionis Pharmaceuticals, Inc.); the NDA 218614 record on Drugs@FDA; every olezarsen label on DailyMed.
Highlights of the record
FDA label of July 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTRYNGOLZA ® is indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS).
Forms and strengths
- 50 mg/.8ml
- 80 mg/.8ml
Injection (solution).
On the market
- Earliest approval on file
- December 19, 2024 Tryngolza (Autoinjector), Ionis Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 1, 2034 Tryngolza injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 676 through July 30, 2026
What is olezarsen used for?
From the label: indications and usageTRYNGOLZA ® 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).
Conditions named in the indications of olezarsen's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: APOC-III-directed RNA Interaction and Antisense Oligonucleotide.
Source: FDA drug label (TRYNGOLZA), Ionis Pharmaceuticals, Inc., effective July 3, 2026 (SPL set 0f51aa8e-8475-8cf9-e063-6394a90a6848), via openFDA; the full label on DailyMed
Is there a generic for olezarsen (Tryngolza)?
No generic olezarsen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Tryngolza injection: the compound patent runs to May 1, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for olezarsen?
The FDA Adverse Event Reporting System holds 676 reports that list olezarsen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 102 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other apoc-iii-directed rna interactions
- the pharmacologic class, with prices and generics
- Olezarsen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other