olezarsen
olezarsen: sourced relationships with 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.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| IONIS PHARMACEUTICALS INC (IONS) Reported 2024-12-19 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (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
Which companies have sourced relationships with olezarsen?
olezarsen has dated SEC/FDA relationship records for 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). ( 1 ) To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). ( 1 ), dated December 19, 2024.