For familial chylomicronemia syndrome (FCS). NDA 218614, held by Ionis Pharms Inc. Olezarsen Sodium.
As of Nov 13, 2026, NDA 218614 (Tryngolza (Autoinjector)), held by Ionis Pharms Inc, was first approved by FDA on Dec 19, 2024, with 1 approved supplement and 0 published complete response letters.
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).
| Jun 24, 2026 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Dec 19, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Tryngolza (Autoinjector)EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) · solution;subcutaneous | Olezarsen Sodium | RxReference drug |
| Tryngolza (Autoinjector)EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML) · solution;subcutaneous | Olezarsen Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
