# TRYNGOLZA (olezarsen) PDUFA Event: Severe hypertriglyceridemia

Canonical URL: https://biopharmsignal.com/pdufa-calendar/IONS/tryngolza-severe-hypertriglyceridemia

Ticker: IONS

Company: Ionis Pharmaceuticals, Inc.

Event date: 2026-06-30

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-06-24

Application type: sNDA

FDA approved TRYNGOLZA for severe hypertriglyceridemia. FDA approved olezarsen as an adjunct to diet to reduce triglycerides and the risk of acute pancreatit...

## Event Timeline

### June 24, 2026 — FDA approved TRYNGOLZA for severe hypertriglyceridemia

FDA approved olezarsen as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.

[Ionis — TRYNGOLZA sHTG FDA approval](https://ir.ionis.com/news-releases/news-release-details/tryngolzar-olezarsen-approved-fda-first-and-only-treatment)

### November 8, 2025 — Detailed CORE and CORE2 results were presented and published

The pivotal studies showed triglyceride reductions of up to 72% versus placebo and a significant reduction in acute-pancreatitis events; the data were presented at AHA and simultaneously published in the New England Journal of Medicine.

[Ionis — CORE and CORE2 presentation and publication](https://ir.ionis.com/news-releases/news-release-details/groundbreaking-pivotal-study-results-olezarsen-severe)

### September 2, 2025 — CORE and CORE2 reported positive topline results

Both Phase 3 studies met their primary endpoints, and the pooled analysis showed an 85% reduction in acute-pancreatitis events.

[Ionis — Positive CORE and CORE2 topline results](https://ir.ionis.com/node/33001)

### August 31, 2022 — Phase 3 CORE2 study started

CORE2 began evaluating monthly olezarsen in adults with severe hypertriglyceridemia.

[ClinicalTrials.gov — CORE2 study record (NCT05552326)](https://clinicaltrials.gov/study/NCT05552326)

### October 25, 2021 — Phase 3 CORE study started

CORE began evaluating monthly olezarsen in adults with severe hypertriglyceridemia.

[ClinicalTrials.gov — CORE study record (NCT05079919)](https://clinicaltrials.gov/study/NCT05079919)

## Related Pages

- IONS PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/IONS.md

- IONS company profile: https://biopharmsignal.com/company/IONS.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md