Drugs / Olezarsen
Drug research

Olezarsen

Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.

Drug identity checked against registry records

Also recorded as AKCEA -APOCIII-LRx; AKCEA-APOCIII-LRx; ISIS 678354

A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.

Included trials

TrialSponsorPhaseStatusPrimary completion
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe HypertriglyceridemiaNCT05355402IONSPhase 2Completed2023-03-22Actual
A Study of Olezarsen Administered Subcutaneously to Participants With Severe HypertriglyceridemiaNCT05552326IONSPhase 3Completed2024-12-17Actual
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)NCT05130450IONSPhase 3Active not recruiting2028-02Estimated
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe HypertriglyceridemiaNCT05079919IONSPhase 3Completed2024-10-22Actual
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)NCT04568434IONSPhase 3Completed2023-07-14Actual
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With VolanesorsenNCT05185843IONSPhase 3Active not recruiting2027-06Estimated
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)NCT05681351IONSPhase 3Active not recruiting2027-03Estimated
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe HypertriglyceridemiaNCT05610280IONSPhase 3Completed2024-08-08Actual

Regulatory dates and decisions

No regulatory events match this view.Try another date range or view. Events appear after automated source checks. This does not mean no FDA events have occurred. Dates that a source does not disclose stay undisclosed.