Drugs / Plozasiran
last change Sep 2026 re-read 3 minutes ago

Plozasiran

also known as ADS-005 · ADS-005 FREE ACID · ARO-APOC3 · VSA001

Small interfering RNA (siRNA) targets APOC3 via inhibition

Developed for
familial chylomicronemia syndrome · hypertriglyceridemia · hyperlipidemia
Investigated by
Arrowhead Pharmaceuticals · Visirna Therapeutics HK Limited

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed familial chylomicronemia syndrome 2 milestones
Filed China (NMPA) — familial chylomicronemia syndrome 2025-01-26

“submitted a New Drug Application (NDA) for plozasiran to the National Medical Products Administration (NMPA) in China for the treatment of FCS” arrowheadpharma.com ↗

“Plozasiran, has had its new drug application (NDA) (Acceptance No. JXHS2500018) officially accepted” visirna.com ↗

Filed US (FDA) — familial chylomicronemia syndrome 2024-11-18

“submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS)” arrowheadpharma.com ↗

“Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome” arrowheadpharma.com ↗

Approved Indication not stated 2 milestones
Approved EU (EMA) Redemplo — 2026-06-19 europa.eu ↗
Approved US (FDA) REDEMPLO — 2025-11-18 fda.gov ↗

Trials 10

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials · 1 met primary
Phase 2 NCT05413135 Jul 2022 → Sep 2025 hyperlipidemia Arrowhead Pharmaceuticals Completed No outcome recorded
Phase 2 NCT04720534 May 2021 → Mar 2023 — Arrowhead Pharmaceuticals Completed Met primary
Phase 37 trials · 4 met primary
Phase 3 NCT06880770 Apr 2025 → Mar 2029 expected — Arrowhead Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT06822790 Apr 2025 → Jul 2028 expected hypertriglyceridemia Arrowhead Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT06347016 Jul 2024 → Jun 2026 overdue — Arrowhead Pharmaceuticals Active not recruiting Met primary
Phase 3 NCT06347003 Jul 2024 → Jun 2026 overdue — Arrowhead Pharmaceuticals Active not recruiting Met primary
Phase 3 NCT06347133 May 2024 → Jun 2026 overdue hypertriglyceridemia Arrowhead Pharmaceuticals Active not recruiting No outcome recorded
Phase 3 NCT05902598 Jul 2023 → Nov 2024 familial chylomicronemia syndrome Visirna Therapeutics HK Limited Completed Met primary
Phase 3 NCT05089084 Dec 2021 → Apr 2024 familial chylomicronemia syndrome Arrowhead Pharmaceuticals Completed Met primary
Phase not stated1 trial
— NCT06796426 — familial chylomicronemia syndrome, hypertriglyceridemia Arrowhead Pharmaceuticals Available No outcome recorded
Comparator or background therapy1 trial
Phase 1 NCT05757596 Comparator May → Sep 2023 — Visirna Therapeutics HK Limited Completed No outcome recorded

News releases announcing trial results or a regulatory action · 41

DateIssuerRelease
2026-08-30 Arrowhead Pharmaceuticals Results Arrowhead Pharmaceuticals Presents Phase 3 SHASTA-3 and SHASTA-4 Data Demonstrating Plozasiran Reduced Acute Pancreatitis Events in Patients with Severe Hypertriglyceridemia arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented results from the pivotal Phase 3 SHASTA-3 and SHASTA-4 studies of plozasiran in adults with severe hypertriglyceridemia (sHTG)
2026-08-17 Arrowhead Pharmaceuticals Regulatory People Living with Familial Chylomicronaemia Syndrome (FCS) in Germany Have Access to REDEMPLO® (plozasiran) as a New Treatment Option to Reduce Triglycerides arrowheadpharma.com ↗
Following its marketing authorization by the European Commission in June 2026, REDEMPLO® (plozasiran) is now listed in the Lauer-Taxe® database and thus able to be prescribed, dispensed and reimbursed in Germany.
2026-08-04 Arrowhead Pharmaceuticals Regulatory Arrowhead Pharmaceuticals Acquires FDA Priority Review Voucher arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has signed an agreement with an undisclosed third party to acquire a U.S. Food and Drug Administration (FDA) Rare Pediatric Disease Priority Review Voucher (PRV).
2026-07-22 Arrowhead Pharmaceuticals Results Arrowhead Pharmaceuticals Reports Topline Results from Phase 3 SHASTA-3 and SHASTA-4 Studies of Plozasiran in Patients with Severe Hypertriglyceridemia arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced topline results for the global Phase 3 SHASTA-3 and SHASTA-4 clinical studies of plozasiran in patients with severe hypertriglyceridemia (sHTG), a condition that significantly increases the risk of acute pancreatitis (AP), which is associated with repeated hospital admissions and can be fatal.
2026-06-22 Arrowhead Pharmaceuticals Regulatory Arrowhead Pharmaceuticals Receives Marketing Authorization in the European Union for REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the European Commission (EC) has formally granted marketing authorization for REDEMPLO® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS).
2026-05-26 Arrowhead Pharmaceuticals Results Arrowhead Pharmaceuticals Presents New Positive Clinical Cardiometabolic Data at the 94th European Atherosclerosis Society (EAS) Congress arrowheadpharma.com ↗
New data support potential use of plozasiran without dose adjustment in patients with moderate-to-severe renal or moderate hepatic impairment
2026-05-01 Arrowhead Pharmaceuticals Regulatory Arrowhead Pharmaceuticals Receives TGA Approval of REDEMPLO® (plozasiran) in Australia, Expanding Global Access for Patients with Familial Chylomicronemia Syndrome (FCS) arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the Australian Therapeutic Goods Administration (TGA) has approved REDEMPLO® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate.
2026-04-24 Arrowhead Pharmaceuticals Regulatory Arrowhead Pharmaceuticals Receives Positive CHMP Opinion Recommending Approval of REDEMPLO® (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) in Europe arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA CHMP) has adopted a positive opinion, recommending the approval of REDEMPLO® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS).
2026-03-28 Arrowhead Pharmaceuticals Results Arrowhead Pharmaceuticals Presents New Long-Term Efficacy and Safety Data for Plozasiran Across a Spectrum of Hypertriglyceridemia at the American College of Cardiology’s 75th Annual Scientific Session and Expo arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced long-term efficacy and safety data from a two-year long open-label extension (OLE) study of investigational plozasiran supporting its potential as therapeutic solution for a diverse spectrum of patients with hypertriglyceridemia (HTG).
2026-01-15 Sanofi Regulatory Press Release: Myqorzo and Redemplo approved in China sanofi.com ↗
Myqorzo and Redemplo approved in China
2026-01-07 Arrowhead Pharmaceuticals Regulatory Arrowhead Pharmaceuticals Announces NMPA Approval of REDEMPLO® (plozasiran) for Familial Chylomicronemia Syndrome (FCS) in China arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the Chinese National Medical Products Administration (NMPA) has approved REDEMPLO® (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS).
2026-01-05 Arrowhead Pharmaceuticals Regulatory Arrowhead Pharmaceuticals Announces Health Canada Approval of REDEMPLO™ (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS) arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that Health Canada has issued a Notice of Compliance (NOC) authorizing REDEMPLO™ (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate.

All press releases naming this drug 57 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Plozasiran “Plozasiran (VSA001, ARO-APOC3) is an RNA interference therapy that targets Apolipoprotein C3 (APOC3), a key regulator of lipoprotein metabolism.” PMID 41094680 ↗ Oct 2025
10

“Plozasiran, a hepatocyte-targeted siRNA against apolipoprotein C-III” PMID 42291067 ↗ Mar 2026

“Plozasiran induced significant dose-dependent” PMID 38583092 ↗ Jul 2024

NCT06347016 ↗

NCT06347003 ↗

NCT06347133 ↗

NCT06880770 ↗

NCT05902598 ↗

NCT06822790 ↗

NCT05089084 ↗

NCT06796426 ↗

Known as ADS-005 ChEMBL registry synonym — accepted as the source's own label CHEMBL6068438 ↗
Known as ADS-005 FREE ACID ChEMBL registry synonym — accepted as the source's own label CHEMBL6068438 ↗
Known as ARO-APOC3 “Plozasiran (VSA001, ARO-APOC3) is an RNA interference therapy that targets Apolipoprotein C3 (APOC3), a key regulator of lipoprotein metabolism.” PMID 41094680 ↗ Oct 2025
Known as VSA001 “Plozasiran (VSA001, ARO-APOC3) is an RNA interference therapy that targets Apolipoprotein C3 (APOC3), a key regulator of lipoprotein metabolism.” PMID 41094680 ↗ Oct 2025
Action Inhibit “reduces hepatic production of apolipoprotein C-III” PMID 39225259 ↗ Sep 2024
Modality Small interfering RNA (siRNA) “Plozasiran is a small interfering RNA” PMID 39225259 ↗ Sep 2024
Route Subcutaneous “receive subcutaneous plozasiran (25- or 50-mg)” PMID 41923352 ↗ Apr 2026
Target APOC3 “Plozasiran is a small interfering RNA that reduces hepatic production of apolipoprotein C-III” PMID 39225259 ↗ Sep 2024