CARLSBAD, Calif., June 24, 2026
Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA® (olezarsen) as the first and only treatment indicated to reduce both triglyceride levels and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG). The approval marks a significant milestone for the company and represents Ionis’ first independent commercial launch in a prevalent disease. TRYNGOLZA is administered once monthly through a self-injection autoinjector and is available in 50 mg and 80 mg doses. The therapy is designed for patients with triglyceride levels of 500 mg/dL or higher, a population at elevated risk for acute pancreatitis, a serious and potentially life-threatening condition associated with severe abdominal pain, hospitalization, and long-term organ damage.
Phase 3 Studies Demonstrated Significant Triglyceride Reduction
The FDA approval was supported by positive findings from the pivotal Phase 3 CORE and CORE2 clinical trials, which evaluated the efficacy and safety of olezarsen in patients with severe hypertriglyceridemia. In these studies, TRYNGOLZA reduced fasting triglyceride levels by up to 72% compared with placebo at six months, with reductions maintained through 12 months of treatment. Importantly, the therapy also demonstrated a substantial impact on clinical outcomes, reducing acute pancreatitis events by up to 91%. Among patients with available baseline and one-year data, 86% achieved triglyceride levels below 500 mg/dL, a key target associated with lowering pancreatitis risk. The studies enrolled more than 1,000 participants globally, all of whom received standard-of-care lipid-lowering treatments alongside the investigational therapy.
First Therapy Approved to Reduce Acute Pancreatitis Risk in sHTG
Severe hypertriglyceridemia affects more than 3 million people in the United States, including approximately one million individuals considered at particularly high risk due to extremely elevated triglycerides or a history of pancreatitis. Existing therapies and lifestyle interventions often fail to consistently lower triglycerides to safer levels. TRYNGOLZA is the first FDA-approved treatment specifically indicated to reduce the risk of acute pancreatitis in this patient population, addressing a major unmet medical need. The therapy works by targeting apolipoprotein C-III (apoC-III), a liver-produced protein that plays a central role in triglyceride metabolism. By reducing apoC-III production through Ionis’ proprietary RNA-targeted technology, TRYNGOLZA helps lower circulating triglycerides and improve lipid control.
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Commercial Launch Planned for July 2026
Ionis expects TRYNGOLZA to become commercially available in the United States during July 2026. To support patient access, the company has introduced the Ionis Every Step™ program, offering insurance assistance, injection training, nutritional support, and financial assistance resources. Across the clinical development program, TRYNGOLZA demonstrated a favorable safety profile, with the most common adverse events including injection-site reactions and elevated liver enzymes. The approval further strengthens Ionis’ leadership in RNA-based therapeutics and expands the company’s presence in cardiometabolic disease beyond its previously approved rare disease treatments. With the introduction of TRYNGOLZA, healthcare providers now have a novel therapeutic option capable of delivering meaningful triglyceride reductions while helping protect patients from one of the most serious complications of severe hypertriglyceridemia.
Source: Ionis Pharmaceuticals press release
