Is Plozasiran approved by the US FDA?

Drugs@FDA lists 1 application product line for Plozasiran, including REDEMPLO (Prescription).

Is Plozasiran authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Plozasiran: Redemplo.

Active substance

Plozasiran

US FDA 1
EMA 1
Health Canada 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	solution · subcutaneous	ARROWHEAD	Prescription	18 Nov 2025

EMA European Union — centrally authorised medicines

Redemplo Arrowhead Pharmaceuticals Ireland Limited · Authorised · authorised 19 Jun 2026 · ATC C10AX

Therapeutic indication (EMA)

Redemplo is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS) (see section 4.2 for patient selection criteria).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REDEMPLO	02564327	25 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ARROWHEAD PHARMACEUTICALS, INC.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.