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Molecule

Plozasiran

APOC-III-directed RNA Interaction
Available on requestOrphanCold chainCardiology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Plozasiran is an APOC-III-directed RNA interaction indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). It is available as injection for subcutaneous use. MedsAcross supplies Plozasiran for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
APOC-III-directed RNA Interaction, Rna, Small Interfering RNA, Increased RNA Degradation
ATC classification
C10AX Cholesterol and lipid-lowering medicines, subgroup C10A, subgroup C10AX · Cholesterol and lipid-lowering medicines, subgroup C10A
US FDA first approval
18 November 2025
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Identifiers
UNII XG9ARL6P25CAS 2379776-40-4DrugBank DB18997Q136334524

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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).

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months. 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.

Source: US FDA prescribing information

Side effects

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.

Source: US FDA prescribing information

Storage

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.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Plozasiran, sorted by availability.

MedicineManufacturerRegisterAvailability
Redemplo 50 mg/1 mL injectionSubcutaneous Cold chainArrowhead PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 18 November 2025Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Plozasiran available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Plozasiran and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Plozasiran have?

The catalogue lists 1 brand names for Plozasiran, including Redemplo.

Is Plozasiran approved by the US FDA?

Yes. The US FDA first approved Plozasiran on 18 November 2025, according to Drugs@FDA.

Is Plozasiran authorised in the European Union?

Yes. Plozasiran has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Plozasiran need cold chain shipping?

At least one listed presentation of Plozasiran must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Plozasiran in?

Plozasiran is classified under ATC code C10AX (Cholesterol and lipid-lowering medicines, subgroup C10A, subgroup C10AX).

References

  1. REDEMPLO prescribing information (Arrowhead Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 25 August 2026
  2. Redemplo: European public assessment report (EPAR). European Medicines Agency. Retrieved 3 July 2026

Request Plozasiran for export supply

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