Is Olezarsen approved by the US FDA?

Drugs@FDA lists 1 application product line for Olezarsen, including TRYNGOLZA (AUTOINJECTOR) (Prescription).

Is Olezarsen authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Olezarsen: Tryngolza.

Are there safety signals or safety updates for Olezarsen?

US FDA: 1 entry (latest 2026-06-24).

Active substance

Olezarsen

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
TRYNGOLZA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML); EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)	solution · subcutaneous	IONIS PHARMS INC	Prescription	19 Dec 2024

EMA European Union — centrally authorised medicines

Tryngolza Swedish Orphan Biovitrum AB (publ) · Authorised · authorised 17 Sep 2025 · ATC C10AX

Therapeutic indication (EMA)

Tryngolza is indicated as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome (FCS).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRYNGOLZA	02563886	80 MG / 0.8 ML	SOLUTION · SUBCUTANEOUS	CELYSTRA PHARMA INC.

Safety signals and safety-related labeling changes

US FDA 24 Jun 2026 TRYNGOLZA (AUTOINJECTOR) — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for olezarsen →

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.