Plozasiran

Plozasiran is a siRNA conjugated with GalNAc that degrades the apoC-III mRNA through the RNA interference mechanism resulting in reduced levels of hepatic and serum apoC-III protein. Reduction of apoC- III protein leads to increased clearance of serum triglycerides.

• 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 (siRNA) indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

• None. None.contraindicated

The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months. ( 2.1 ) Inject REDEMPLO subcutaneously into the front of the thigh or abdomen. The outer area of the upper arm can be used as an injection site if a healthcare provider or caregiver administers the injection. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months. 2.2 Important Administration Instructions Prior to initiation, train patients and/or caregivers on proper preparation and administration of REDEMPLO [see Instructions for Use ] . Adhere to a low-fat diet (less than or equal to 20 grams fat per day) in conjunction with REDEMPLO. Visually inspect the REDEMPLO pre-filled syringe prior to administration. The solution should be clear and colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration. Inject REDEMPLO subcutaneously into the front of the thigh or abdomen. The outer area of the upper arm can be used as an injection site if a healthcare provider or caregiver administers the injection. Do not inject REDEMPLO in an area where the skin is damaged (tender, bruised, red, hard, or cut). Do not inject into areas with scars or stretch marks. If a dose is missed, administer REDEMPLO as soon as possible. Resume dosing every 3 months from the date of the most recently administered dose.

Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Arrowhead Pharmaceuticals Inc. at 1-844-REDEMPLO (1-844-733-3675), or https://arrowheadpharma.com/safetyreporting, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of REDEMPLO cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of REDEMPLO was evaluated in 75 patients with FCS enrolled in Trial 1 (NCT05089084) [see Clinical Studies ( 14 )] . In this trial, patients received at least one dose of REDEMPLO 25 mg (N=26) or 50 mg of plozasiran (N=24) and 25 patients received placebo. Plozasiran 50 mg is not an approved dosage regimen for FCS [see Dosage and Administration ( 2.1 )] . Across treatment groups, the mean age was 46 years and 49% of patients were male. Seventy-three percent (73%) of patients were White, 21% were Asian, and 5% were reported as other races; 3% identified as Hispanic or Latino ethnicity. Fifty (50) patients were exposed to REDEMPLO for a median of 11.6 months; 26 patients were treated with REDEMPLO 25 mg every 3 months for a median of 11.8 months.

8.1 Pregnancy Risk Summary There are insufficient data on REDEMPLO use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Patients with FCS are at risk for pancreatitis during pregnancy because of defects in lipid metabolism and increased triglyceride levels (see Clinical Considerations ) . In animal reproduction studies, no adverse drug-related developmental effects were observed in pregnant rats or rabbits with subcutaneous administration of plozasiran during organogenesis up to 23 and 140 times, respectively, the maximum recommended human dose (MRHD) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Triglyceride levels increase during the third trimester of pregnancy. In patients with underlying defects in lipid metabolism, such as FCS, severe gestational hypertriglyceridemia may occur, increasing the risk of acute pancreatitis during pregnancy.

Metabolism

REDEMPLO exhibited linear and time-invariant pharmacokinetics following subcutaneous injections within the dose range of 10 mg to 100 mg. The following pharmacokinetic parameters were observed in healthy adults after receiving a 25 mg dose of REDEMPLO.

• Nov 18, 2025NDANDA219947Arrowhead

1. 1Nausea744%
2. 2Blood Glucose Increased425%
3. 3Headache425%
4. 4Abdominal Discomfort16.3%
5. 5Back Pain16.3%
6. 6Device Breakage16.3%
7. 7Device Occlusion16.3%
8. 8Diarrhoea16.3%
9. 9Dizziness16.3%
10. 10Dyspnoea16.3%
11. 11Gait Disturbance16.3%
12. 12Head Discomfort16.3%
13. 13Hepatic Enzyme Increased16.3%
14. 14Hyperglycaemia16.3%
15. 15Injection Site Erythema16.3%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Plozasiran as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
  Recruiting · Phase 3 · Interventional · 288 enrolled · Arrowhead Pharmaceuticals
  NCT06880770updated 2026-06-10
• Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)
  Completed · Phase 3 · Interventional · 75 enrolled · Arrowhead Pharmaceuticals
  NCT05089084updated 2026-06-05
• Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
  Recruiting · Phase 3 · Interventional · 869 enrolled · Arrowhead Pharmaceuticals
  NCT06822790updated 2026-06-02
• Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia
  Completed · Phase 2 · Interventional · 353 enrolled · Arrowhead Pharmaceuticals
  NCT04998201updated 2026-04-14
• Treatment Protocol of Plozasiran in Adults With High-Risk Severe Hypertriglyceridemia (SHTG) and in Adults and Adolescents With FCS
  Available · Expanded access · Arrowhead Pharmaceuticals
  NCT06796426updated 2026-03-03
• A Phase 3 Study of ARO-APOC3 / VSA001 / SAR449124 (Plozasiran) in Chinese Adults With Familial Chylomicronemia Syndrome
  Completed · Phase 3 · Interventional · 37 enrolled · Visirna Therapeutics HK Limited
  NCT05902598updated 2026-02-27
• Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
  Active not recruiting · Phase 3 · Interventional · 446 enrolled · Arrowhead Pharmaceuticals
  NCT06347003updated 2025-10-27
• Study of Plozasiran in Adults With Severe Hypertriglyceridemia
  Active not recruiting · Phase 3 · Interventional · 311 enrolled · Arrowhead Pharmaceuticals
  NCT06347016updated 2025-10-24
• Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
  Active not recruiting · Phase 3 · Interventional · 1,456 enrolled · Arrowhead Pharmaceuticals
  NCT06347133updated 2025-10-08

Frequently asked questions

How does Plozasiran work?

Plozasiran is a siRNA conjugated with GalNAc that degrades the apoC-III mRNA through the RNA interference mechanism resulting in reduced levels of hepatic and serum apoC-III protein. Reduction of apoC- III protein leads to increased clearance of serum triglycerides.

What is Plozasiran used for?

According to FDA labeling, Plozasiran carries indications including: 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 (siRNA) indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Plozasiran?

Plozasiran is classified as APOC-III-directed RNA Interaction, Small Interfering RNA, APOC-III RNA Antisense Inhibitor, Decreased Protein Synthesis, Increased RNA Degradation.

What are the brand names for Plozasiran?

Plozasiran is marketed under brand names including Redemplo.

What are the contraindications for Plozasiran?

Plozasiran labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.