Product Description
Olezarsen, formerly known as IONIS-APOCIII-LRx and AKCEA-APOCIII-LRx, is an investigational ligand-conjugated antisense (LICA) medicine designed to inhibit the production of apoC-III for patients who are at risk of disease due to elevated triglyceride levels. It is a treatment for severe hypertriglyceridemia. (Sourced from: https://www.ionispharma.com/medicines/akcea-apociii-l/)
Mechanisms of Action: APOC3 Inhibitor
Novel Mechanism: Yes
Modality: Nucleic Acid
Route of Administration: Subcutaneous
FDA Designation: Fast Track - Orphan Drug - Familial Chylomicronemia SyndromePriority Review - Familial Chylomicronemia Syndrome *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Ionis
Company Location: CARLSBAD CA 92010
Company CEO: Brett P. Monia
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Active Clinical Trial Count: 17
Highest Development Phases
Phase 3: Atherosclerosis|Familial Chylomicronemia Syndrome|Hyperlipoproteinemia Type I|Hypertriglyceridemia
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ISIS 304801 | P3 |
Active, not recruiting |
Hyperlipoproteinemia Type I|Familial Chylomicronemia Syndrome |
2027-06-01 |
|
| SHTG | P3 |
Recruiting |
Hypertriglyceridemia |
2026-05-01 |
|
| ISIS 678354-CS15 | P3 |
Unknown Status |
Hypertriglyceridemia |
2026-04-01 |
|
| 2021-002192-19 | P3 |
Active, not recruiting |
Hypertriglyceridemia |
2025-12-22 |