vutrisiran

Orphan Drug Cold Chain RequiredFDA Approved (2022), EMA Approved (2022)

Description

Vutrisiran is a subcutaneously administered RNAi therapeutic targeting transthyretin (TTR) for hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy. It uses enhanced stabilization chemistry (ESC) allowing quarterly dosing, a significant improvement over monthly administration. The drug demonstrated robust TTR reduction and clinical benefit in the HELIOS-A phase 3 trial.

Indications & Therapeutic Use

Hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults

Global Availability (6 countries)

CountryAccess RouteRegulatory PathwayLead TimeStatus

Available Through

This drug is available for procurement through the following fulfilment partner.

Fulfilment Partner
vutrisiran
Generic Namevutrisiran
Brands1 brand available
Active Ingredientvutrisiran sodium
Drug ClassHereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults
ManufacturerAlnylam Pharmaceuticals
Dosage FormsSubcutaneous injection, 25mg/0.5mL pre-filled syringe
Medical CodeN07XX14
Orphan StatusYes — Orphan Drug
Cold ChainRequired
Lead Time18 days
Reg. StatusFDA Approved (2022), EMA Approved (2022)
Clinical TrialNCT03759379
Countries6 countries
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations7 Validated Nodes