Olezarsen
Orphan Drug Cold Chain RequiredFDA Approved (2024)
Description
An APOC3-targeting antisense oligonucleotide given as a monthly subcutaneous injection for familial chylomicronemia syndrome. FDA-approved December 2024 as an adjunct to diet to lower triglycerides.
Indications & Therapeutic Use
Familial chylomicronemia syndrome (FCS)
Linked Diseases:
familial chylomicronemia syndrome
Evidence: FDA-approved indication
Global Availability (1 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| Standard Marketing Authorization | — | — | Approved |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Olezarsen
| Generic Name | olezarsen |
| Brands | 1 brand available |
| Active Ingredient | olezarsen |
| Drug Class | Familial chylomicronemia syndrome (FCS) |
| Manufacturer | Ionis Pharmaceuticals |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Required |
| Reg. Status | FDA Approved (2024) |
| Countries | 1 countries |
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes