FDA
Redemplo approved for familial chylomicronemia syndrome
Brand name: Redemplo
Generic name: plozasiran
Manufacturer: Arrowhead Pharmaceuticals
Approval date: November 18, 2025
FDA approved Redemplo (plozasiran), an apolipoprotein C-III-directed small interfering ribonucleic acid (siRNA), as an adjunct to diet to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS).
Efficacy
The efficacy of Redemplo was demonstrated in the randomized, placebo-controlled, double-blind PALISADE trial (NCT05089084) in adults with genetically confirmed or clinically diagnosed FCS maintained on a low-fat diet (≤20 grams fat per day). Patients were randomly assigned to receive four total doses of Redemplo 25 mg or matching placebo, injected SC once every three months over a 12-month treatment period. Primary endpoint was percent change in fasting TGs from baseline to month 10. Median percent change in TG from baseline to month 10 in the Redemplo treatment group was -59% compared with the placebo group.
Safety
The most common side effects are hyperglycemia, headache, nausea, and injection site reaction.
Recommended dose
Redemplo is administered as a 25-mg SC injection once every three months into the front of the thigh or abdomen. The outer area of the upper arm can be used as an injection site if a health care provider or caregiver administers the injection.
Sources:
FDA Approves Redemplo (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome. [News release]. 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-reduce-triglycerides-adults-familial-chylomicronemia-syndrome
Redemplo (plozasiran) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219947s000lbl.pdf Revised November 2025. Accessed November 20, 2025.
Arrowhead Pharmaceuticals announces FDA approval of Redemplo® (plozasiran) to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). [News release]. 2025. https://arrowheadpharma.com/news-press/arrowhead-pharmaceuticals-announces-fda-approval-of-redemplo-plozasiran-to-reduce-triglycerides-in-adults-with-familial-chylomicronemia-syndrome-fcs/