Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025

Shots: The P-III (CORE: n=617 & CORE2: n=446) trials assessed olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults; the US FDA’s sNDA filing is expected by 2025 end Both trials met their 1EP with ~72% PBO-adjusted fasting triglyceride (TG) reduction at 6mos., sustained to 12mos., while 89% (50mg) & 88%…

ByRidhi RastogiNovember 10, 2025

Ionis Reveals Topline P-III (CORE & CORE2) Trial Data of Olezarsen for Severe Hypertriglyceridemia

Shots: Ionis has reported P-III (CORE: n=617 & CORE2: n=446) trials data assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in adults with severe hypertriglyceridemia (sHTG); the US FDA’s sNDA submission expected by year end Both studies met their 1EP, with CORE showing reduction in fasting triglycerides by 72% (80mg) & 63%…

ByRidhi RastogiSeptember 4, 2025

Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS)

Shots: The US FDA has approved Tryngolza (80mg, QM, self-administered via an auto-injector) as an adj. for reducing triglycerides (TG) in FCS patients, based on a P-III (BALANCE) study. Further submission is under review in the EU, with more filings planned The P-III study involved FCS patients with fasting TG levels of ≥880mg/dL. Trial showed…

ByDipanshu DixitDecember 19, 2024

Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025

Ionis Reveals Topline P-III (CORE & CORE2) Trial Data of Olezarsen for Severe Hypertriglyceridemia

Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS)

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