Primary completion· ClinicalTrials.gov
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
Plozasiran History and Updates
29 events · 2021 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
1
FDA Approvals
1
Label Revisions
27
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-01Download 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 (8)
2026
- Label revisionRedemplo label adds FCS triglyceride-reduction indication· Aug 25, 2026
- Primary completionPlozasiran phase 3 severe hypertriglyceridemia trial reaches primary completion· Jun 17, 2026
- Primary completionPlozasiran Phase 3 Trial for Severe Hypertriglyceridemia Completes Primary Study· Jun 12, 2026
- Primary completionPlozasiran Phase 3 Trial for Hypertriglyceridemia Reaches Primary Completion· Jun 1, 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 completion· ClinicalTrials.gov
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Past events
2026
Label revision· FDA
1 INDICATIONS AND USAGE REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). REDEMPLO is an apolipoprotein C-III ( apoC-III )-directed small interfering ribonucleic acid
Primary completion· ClinicalTrials.gov
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
Primary completion· ClinicalTrials.gov
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Primary completion· ClinicalTrials.gov
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Primary completion· ClinicalTrials.gov
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
Primary completion· ClinicalTrials.gov
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Primary completion· ClinicalTrials.gov
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Results posted· ClinicalTrials.gov
A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome
Results posted· ClinicalTrials.gov
Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
2025
FDA approval· FDA
Sponsor: ARROWHEAD. Class: Type 1 - New Molecular Entity.
Trial started· ClinicalTrials.gov
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Trial started· ClinicalTrials.gov
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
Trial registered· ClinicalTrials.gov
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Trial registered· ClinicalTrials.gov
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
Trial registered· ClinicalTrials.gov
Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS
2024
Primary completion· ClinicalTrials.gov
A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome
Trial started· ClinicalTrials.gov
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Trial started· ClinicalTrials.gov
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
Trial started· ClinicalTrials.gov
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Primary completion· ClinicalTrials.gov
Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
Trial registered· ClinicalTrials.gov
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
Trial registered· ClinicalTrials.gov
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Trial registered· ClinicalTrials.gov
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
2023
Trial started· ClinicalTrials.gov
A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome
Trial registered· ClinicalTrials.gov
A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome
2021
Trial started· ClinicalTrials.gov
Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
Trial registered· ClinicalTrials.gov
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.