Tryngolza Gains Expanded Triglyceride-Lowering Indication

The FDA approved olezarsen (Tryngolza, Ionis Pharmaceuticals) as an adjunct to diet for adults with severe hypertriglyceridemia to lower triglyceride levels and reduce the risk of acute pancreatitis.

The approval makes Tryngolza the first FDA-approved therapy specifically shown to reduce acute pancreatitis risk in this patient population. The once-monthly subcutaneous treatment is intended for adults whose fasting triglyceride levels are at least 500 mg/dL. The FDA noted that normal triglyceride levels are below 150 mg/dL and that current guidelines recommend reducing levels above 500 mg/dL because of the associated pancreatitis risk.

The approval was supported by 2 randomized, double-blind, placebo-controlled clinical trials involving 1,061 adults with severe hypertriglyceridemia. At baseline, participants had an average triglyceride level of 1,116 mg/dL. Both trials evaluated the percent change in fasting triglycerides from baseline to month 6, comparing Tryngolza with placebo.

In the first trial, the placebo-corrected differences in percent change in fasting triglycerides from baseline at month 6 were −63% with the 50-mg dose and −72% with the 80-mg dose. In the second trial, the corresponding placebo-corrected differences were −49% and −55%, respectively. An integrated analysis of both trials also showed a lower adjudicated acute pancreatitis event rate in the pooled Tryngolza group than in the placebo group.

Injection-site reactions and increased liver enzymes were the most common adverse reactions reported with Tryngolza in adults with severe hypertriglyceridemia. According to the FDA, health care providers should consider checking liver enzymes before starting treatment, before dose increases, and later when clinically indicated. The agency granted the application Priority Review and Breakthrough Therapy designations.

Source: FDA. FDA approves first treatment shown to reduce the risk of acute pancreatitis in adults with severe hypertriglyceridemia. Published June 24, 2026. Accessed July 1, 2026.