Selected approval record (2025-11-18): FDA approved plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome. The labeled dosing interval is every three months.
Severe hypertriglyceridemia, fasting triglycerides≥500 mg/dL
Median within-arm percentage change at month 12; not a placebo-adjusted percentage.
Safety context
Pooled trials: adverse events 73% in both arms; worsening glycemic control 14.3% vs 8.7%; serious events 8.3% vs 10% (plozasiran/placebo).
Limitations: Sponsor presentation. Replicate trials remain separate. Redemplo is approved for FCS; broader severe-TG indication was still being pursued.
Severe hypertriglyceridemia, fasting triglycerides≥500 mg/dL
Median within-arm percentage change at month 12; not a placebo-adjusted percentage.
Safety context
Pooled trials: adverse events 73% in both arms; worsening glycemic control 14.3% vs 8.7%; serious events 8.3% vs 10% (plozasiran/placebo).
Limitations: Sponsor presentation. Replicate trials remain separate. Redemplo is approved for FCS; broader severe-TG indication was still being pursued.
Status in this atlas: Selected approval record (2025-11-18): FDA approved plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome. The labeled dosing interval is every three months. Status source
Uses RNA interference to degrade apoC-III messenger RNA, reducing apoC-III protein production.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
Chemically modified double-stranded siRNA with a three-residue GalNAc targeting ligand.
Shown: Plozasiran; the label describes the administered sodium salt and provides the drug structural formula.
Exact label sequence/chemical diagram. The linked label explains the underlined nucleotides, linkage symbols, and ligand groups. No 3D conformation is implied.
A next milestone is not summarized for this therapy. This does not mean development has ended.
Development history4 selected milestones
Plozasiran · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.
Study start
First phase 1 volunteer dosed
Arrowhead's FDA-approval presentation dates the first healthy volunteer dose in the ARO-APOC3 phase 1 program to March 2019. The compound was subsequently named plozasiran.
The randomized PALISADE trial in persistent chylomicronemia reported lower triglycerides and fewer pancreatitis events with plozasiran. This population differs from the broader severe-hypertriglyceridemia SHASTA studies.
FDA approved plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome. The labeled dosing interval is every three months.
Arrowhead presented the two plotted phase 3 studies in severe hypertriglyceridemia at ESC. Both met the primary triglyceride endpoint; pancreatitis findings came from a prespecified pooled analysis. This milestone is a sponsor presentation, not a journal publication.
