Press release
Arrowhead Pharmaceuticals Completes Enrollment in SHASTA-3, SHASTA-4, and MUIR-3 Phase 3 Studies of Plozasiran
- Study completion anticipated in mid-2026 with subsequent data readout and regulatory submissions for treatment of severe hypertriglyceridemia PASADENA,
About this update from Arrowhead Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Study completion anticipated in mid-2026 with subsequent data readout and regulatory submissions for treatment of severe hypertriglyceridemia\n\n\n PASADENA, Calif.--(BUSINESS WIRE)--\nArrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has completed enrollment in SHASTA-3, SHASTA-4, and MUIR-3, the company’s global Phase 3 clinical studies designed to support regulatory submissions for marketing approval of investigational plozasiran in the treatment of severe hypertriglyceridemia. Arrowhead anticipates completing the primary portion of these studies in mid-2026 with topline data expected shortly thereafter and planned submissions for regulatory review and potential approval to follow. The company previously submitted a New Drug Application (NDA) for plozasiran based on positive Phase 3 PALISADE study results in patients with familial chylomicronemia syndrome, which the U.S. FDA has accepted with a Prescription Drug User Fee Act (PDUFA) action date set for November 18, 2025.\n\n\n“Completion of enrollment for the SHASTA-3, SHASTA-4, and MUIR-3 studies represent important milestones for plozasiran,” said Bruce Given, M.D., Chief Medical Scientist at Arrowhead. “These studies bring us closer to generating the datasets needed to support potential global regulatory submissions for plozasiran as a treatment for severe hypertriglyceridemia, pending positive results. With a primary endpoint focused on triglyceride reduction at 12 months, we remain on track for study completion by mid-2026. Arrowhead’s clinical development, clinical operations, and regulatory teams continue to execute complex global clinical studies with speed and precision. We owe the entire team involved a debt of gratitude for efficiently initiating these studies in 24 countries and enrolling approximately 2,200 patients. We’re grateful to the investigators, caregivers, and patients for participating in these clinical studies, and we thank them for their trust in Arrowhead and in plozasiran.”\n\n\nAbout Severe Hypertriglyceridemia\n\n\nSevere hypertriglyceridemia (SHTG) is characterized by triglyceride (TG) levels greater than 500 mg/dL, with the most severe form being familial chylomicronemia syndrome (FCS) where TGs typically exceed 880 mg/dL. SHTG significantly increases the risk of acute pancreatitis (AP), which can often include recurrent...