Arrowhead presents plozasiran data supporting use without dose adjustment
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) presented clinical data at the 94th European Atherosclerosis Society Congress showing that plozasiran may be used without dose adjustment in patients with moderate-to-severe renal impairment or moderate hepatic impairment.
The study evaluated the impact of hepatic or renal impairment on the pharmacokinetics, pharmacodynamics, and safety of a single 25 mg dose of plozasiran. Despite modest increases in plozasiran exposure, responses remained similar between control cohorts and those with impairment. The drug was generally safe and well-tolerated with no new safety signals identified.
Plozasiran is a small interfering RNA medicine designed to reduce hepatic production of apolipoprotein C-III through targeted RNA interference. The drug received regulatory approval in the United States, China, Australia, and Canada as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.
The company also presented a case report suggesting that preconception exposure to plozasiran may be associated with sustained lowering of fasting triglyceride levels throughout pregnancy. This represents the second case report published on patients in the PALISADE study who discontinued plozasiran prior to conception and achieved successful pregnancies.
Plozasiran is currently being investigated in patients with severe hypertriglyceridemia in multiple Phase 3 studies. In December 2025, the drug received Breakthrough Therapy designation from the U.S. FDA for severe hypertriglyceridemia treatment.
The presentations took place at the congress in Athens, Greece. The information is based on a company press release statement.
