Olezarsen History and Updates

33 events · 2020 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

1
FDA Approvals
2
Label Revisions
30
Trial Milestones
0
Pivotal Publications
Olezarsen — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20212022202320242025202620272028Trial: NCT05681351 2022-12-13 → 2027-03-31 (primary completion)Trial: NCT05610280 2022-11-21 → 2024-08-08 (primary completion)Trial: NCT05579860 2022-10-05 → 2023-05-22 (primary completion)Trial: NCT05552326 2022-08-31 → 2024-12-17 (primary completion)Trial: NCT05355402 2022-05-09 → 2023-03-22 (primary completion)Trial: NCT05185843 2022-02-25 → 2027-06-30 (primary completion)Trial: NCT05130450 2021-11-18 → 2028-02-29 (primary completion)Trial: NCT05079919 2021-10-25 → 2024-10-22 (primary completion)Trial: NCT04568434 2020-11-18 → 2023-07-14 (primary completion)FDA approval — 2024-12-19 FDA approved Tryngolza (olezarsen sodium) (NDA 218614) Sponsor: IONIS PHARMS INC. Class: Type 1 - New Molecular Entity.Label revision — 2025-01-31 Indication and usage updated on TRYNGOLZA label (effective 2025-01-31) 1 INDICATIONS AND USAGE TRYNGOLZA is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). TRYNGOLZA is an APOC-III -directed antisense oligonucleotide (ASO) indicated as an adjunct Label revision — 2026-07-03 Label revised on TRYNGOLZA label (effective 2026-07-03)Results posted — 2025-03-06 Trial results posted: NCT04568434 A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)Results posted — 2026-04-23 Trial results posted: NCT05355402 A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Etoday (2026-07-09)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-07-09Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Olezarsen since 2020, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (2)

2026
2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05681351
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05185843
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Tr
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05130450
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)

Past events

2026
Results posted· ClinicalTrials.gov
Trial results posted: NCT05355402
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (E
2025
Results posted· ClinicalTrials.gov
Trial results posted: NCT04568434
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)
2024
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05610280
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hype
2023
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04568434
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05579860
A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participant
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05355402
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (E
2022
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05681351
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05610280
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hype
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05579860
A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participant
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05552326
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05355402
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (E
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05185843
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Tr
2021
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05130450
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05079919
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
2020
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04568434
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.