olezarsen
olezarsen: developed by 1 company · 8 clinical trials tracked · 1 FDA decision.
olezarsen evidence translation
What we can confirm
1 FDA record · 8 tracked trials
What it means
What to watch
Prepared research question
How could olezarsen → IONS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (1)
| Company | Phase |
|---|---|
| IONIS PHARMACEUTICALS INC (IONS) | Approved |
Clinical Trials (8)
An Open-Label Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Pediatric Patients With Familial Chylomicronemia Syndrome (FCS)
Primary endpoint: Percent Change from Baseline in Fasting Triglycerides (TG)
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)
Primary endpoint: Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia
Primary endpoint: Percent Change From Baseline to Week 25 in Fasting Triglycerides (TG) Compared to Placebo
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
Primary endpoint: Percent Change from Baseline in Fasting TG Compared to Placebo
A Randomized, Double-blind, Placebo-Controlled, Phase 2b Study of ISIS 678354 in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
Primary endpoint: Percent Change From Baseline in Fasting TG at Month 6
An Open-Label Safety Study of AKCEA-APOCIII-LRX Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen (ISIS 304801)
Primary endpoint: Proportion of Participants With Decrease in Platelet Count by >30% or >50%, or With Platelet Count Value <50,000/cubic millimeter (mm^3)
An Open-Label Extension Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
Primary endpoint: Percent Change From Baseline in Fasting TG at 6 Months (Average of Weeks 23, 25, and 27) Compared to Baseline
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
Primary endpoint: Percent Change from Baseline in Fasting TG Compared to Placebo
FDA Decisions1 records
Frequently asked questions
Who is developing olezarsen?
olezarsen is being developed by IONIS PHARMACEUTICALS INC.
How many clinical trials involve olezarsen?
BioSniper tracks 8 clinical trials involving olezarsen.
What is olezarsen's latest FDA decision?
The most recent tracked FDA decision for olezarsen is Approval for 1 INDICATIONS AND USAGE TRYNGOLZA ® is indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). TRYNGOLZA is an apolipoprotein C-III (apoC-III)-directed antisense oligonucleotide (ASO) indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS), dated December 19, 2024.