Plozasiran History and Updates

25 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 16, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-11Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Plozasiran since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (4)

2026

Results postedPlozasiran Phase 3 Trial Shows Significant Triglyceride Reduction in FCS· Feb 27, 2026
Results postedPlozasiran Phase 3 Trial for FCS Shows Significant Triglyceride Reduction· Feb 4, 2026

2025

FDA approvalFDA Grants Initial Approval to Redemplo (Plozasiran)· Nov 18, 2025

2024

Primary completionPlozasiran Phase 3 FCS Trial: Fasting Triglycerides Reduced by Over 80%· Apr 29, 2024

Upcoming & expected milestones

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06347003

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

Primary completionJun 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06347016

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

Primary completionJul 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT06822790

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Primary completionMar 31, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06880770

Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

Past events

2026

Primary completionMay 31, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT06347133

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Results postedFeb 27, 2026· ClinicalTrials.gov

Trial results posted: NCT05902598

A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome

Results postedFeb 4, 2026· ClinicalTrials.gov

Trial results posted: NCT05089084

Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

2025

FDA approvalNov 18, 2025· FDA

FDA approved Redemplo (plozasiran) (NDA 219947)

Sponsor: ARROWHEAD. Class: Type 1 - New Molecular Entity.

Trial startedApr 24, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06880770

Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

Trial startedApr 9, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06822790

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Trial registeredMar 18, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06880770

Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

Trial registeredFeb 12, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06822790

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Trial registeredJan 28, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT06796426

Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS

2024

Primary completionNov 26, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05902598

A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome

Trial startedJul 23, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06347016

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

Trial startedJul 22, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06347003

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

Trial startedMay 21, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06347133

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Primary completionApr 29, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05089084

Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

Trial registeredApr 4, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06347003

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

Trial registeredApr 4, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06347133

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Trial registeredApr 4, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06347016

Study of Plozasiran in Adults With Severe Hypertriglyceridemia

2023

Trial startedJul 10, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05902598

A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome

Trial registeredJun 15, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05902598

A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome

2021

Trial startedDec 14, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT05089084

Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

Trial registeredOct 22, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05089084

Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.