Brand Name
Redemplo
Generic Name
Plozasiran
View Brand Information FDA approval date: November 19, 2025
Form: Injection
What is Redemplo (Plozasiran)?
REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome . REDEMPLO is an apolipoprotein C-III -directed small interfering ribonucleic acid indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome .
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Brand Information
REDEMPLO (plozasiran)
1INDICATIONS AND USAGE
REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
2DOSAGE FORMS AND STRENGTHS
Injection: 25 mg/0.5 mL of plozasiran as a clear and colorless to yellow solution in a single-dose pre-filled syringe.
3CONTRAINDICATIONS
None.
4DESCRIPTION
REDEMPLO contains plozasiran (present as plozasiran sodium), a small interfering RNA (siRNA) that degrades apolipoprotein C-III (
The molecular formula of plozasiran sodium is C
Abbreviations: A = 2’-O-methyladenosine;
REDEMPLO is a sterile, preservative-free, clear, colorless to yellow solution for subcutaneous use in a prefilled syringe. Each syringe contains 0.5 mL of solution containing 25 mg plozasiran (present as 27 mg plozasiran sodium), sodium chloride to adjust tonicity, and water for injection.
5CLINICAL STUDIES
The efficacy of REDEMPLO was demonstrated in a randomized, placebo-controlled, double-blind trial in adult patients with genetically confirmed or clinically diagnosed FCS maintained on a low-fat diet(≤20 grams fat per day) (Trial 1; NCT05089084). Patients were randomized to receive four total doses of REDEMPLO 25 mg (n=26) or matching placebo (n=25), injected subcutaneously once every 3 months over a 12-month treatment period
The diagnosis of FCS was based on adults with a screening fasting TG ≥880 mg/dL refractory to lipid-lowering therapy, with a history of elevated triglycerides (in excess of 1,000 mg/dL at least three times), and evidence of FCS by known genotypes, evidence of low lipoprotein lipase activity, or a clinical diagnosis. In this trial, for patients with clinically diagnosed FCS, the inclusion criteria specified at least one of the following: recurrent episodes of acute pancreatitis not caused by alcohol or cholelithiasis; recurrent hospitalizations for severe abdominal pain without other explainable cause; childhood pancreatitis; or family history of hypertriglyceridemia-induced pancreatitis.
Patient demographics were generally similar across the treatment groups
The primary efficacy endpoint was percent change in fasting triglycerides from baseline at Month 10 (average of 2 assessments, 2 to 7 days apart). The median difference between REDEMPLO 25 mg and the placebo group in percent change in fasting triglyceride levels from baseline to Month 10 was -58.7% (95% CI: -89.6, -27.9; p< 0.0001). For additional results see
Median percent change in TG from baseline (
Figure 1: Median Percent Change from Baseline in Fasting Triglycerides Over Time in Trial 1
Figure 2: Median Absolute Fasting Triglyceride Levels (mg/dL) in Trial 1
Over the 12-month treatment period, the numerical incidence of acute pancreatitis in patients treated with REDEMPLO 25 mg was lower compared with placebo [2 (8%) patients in the REDEMPLO 25 mg group compared with 5 (20%) patients in the placebo group].
6HOW SUPPLIED/STORAGE AND HANDLING
REDEMPLO injection is a clear and colorless to yellow solution supplied in a single-dose prefilled syringe. Each prefilled syringe of REDEMPLO is filled to deliver 0.5 mL of solution containing 25 mg of plozasiran.
REDEMPLO is available in cartons containing one 25 mg single-dose prefilled syringe each (NDC 84141-025-01).
Storage
Store REDEMPLO refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton, until ready for use.
REDEMPLO prefilled syringe can also be kept at room temperature at 20°C to 25°C (68°F to 77°F) in the original carton for up to 30 days. If not used within the 30 days stored at room temperature, discard REDEMPLO.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Adherence to Diet
Advise patients with FCS that use of lipid-regulating agents does not reduce the importance of adhering to a low-fat diet (less than or equal to 20 grams fat per day)
Missed Dose
Instruct patients to take REDEMPLO as prescribed. If a dose is missed, instruct patients to take as soon as they remember. Resume dosing every 3 months from the date of the most recently administered dose
Distributed by:
Arrowhead Pharmaceuticals, Inc.
Pasadena, CA 91105
© 2025, Arrowhead Pharmaceuticals, Inc.
All rights reserved.
REDEMPLO is a registered trademark of Arrowhead Pharmaceuticals, Inc.
Arrowhead Pharmaceuticals, Inc.
Pasadena, CA 91105
© 2025, Arrowhead Pharmaceuticals, Inc.
All rights reserved.
REDEMPLO is a registered trademark of Arrowhead Pharmaceuticals, Inc.
8PRINCIPAL DISPLAY PANEL - NDC: 84141-025-01 - Carton Label - 25mg/0.5mL
9PRINCIPAL DISPLAY PANEL - NDC: 84141-025-01 - Container Label - 25mg/0.5mL
