All therapiesEvidence snapshot 2026-09-14
Lipids & cardiovascular health

Olezarsen

Targets apoC-III messenger RNA to reduce apoC-III protein production. Source

At a glance

Selected evidence in this atlas
Studied use & population

Moderate triglyceride elevation 150–499 mg/dL and high cardiovascular risk

Study context
Approval & development

Tryngolza is FDA-approved for FCS and, since June 24, 2026, severe hypertriglyceridemia. This plotted trial concerns moderate triglyceride elevation.

Status sourceStatus & indications
Selected efficacy evidence

Triglycerides: 60.6 percentage-point reduction vs placebo · Six months (protocol week 24)

ESSENCE–TIMI 73b · Phase 3 · Peer-reviewed trial · 80 mg every 4 weeks · Primary efficacy cohort with moderate triglyceride elevation; placebo-adjusted least-squares mean change.

Evidence & limitations
Important safety context

Safety cohort: injection-site reactions 16% vs 2%; serious events 14% vs 11% (80 mg/placebo); no Hy’s-law cases.

Safety context
Next milestone

A next milestone is not summarized for this therapy.

Milestone details

Study results apply to their own population, dose and analysis. They do not establish a ranking between therapies.

Evidence in the atlas

1 result

Each result belongs to its own study population, dose and analysis. Open a result for its chart, comparator, safety findings and limitations.

Lipid lowering

ESSENCE–TIMI 73b

Triglycerides: 60.6 percentage-point reduction vs placebo · Six months (protocol week 24)

80 mg every 4 weeks

Moderate triglyceride elevation 150–499 mg/dL and high cardiovascular risk

Primary efficacy cohort with moderate triglyceride elevation; placebo-adjusted least-squares mean change.

Safety context

Safety cohort: injection-site reactions 16% vs 2%; serious events 14% vs 11% (80 mg/placebo); no Hy’s-law cases.

Safety source

Limitations: 1, 349 is the primary efficacy subgroup of 1, 478 randomized. Safety uses the larger treated cohort. Moderate-TG efficacy is distinct from the approved severe-TG indication.

Biology & identity

Status in this atlas: Tryngolza is FDA-approved for FCS and, since June 24, 2026, severe hypertriglyceridemia. This plotted trial concerns moderate triglyceride elevation. Status source

Targets apoC-III messenger RNA to reduce apoC-III protein production.

Mechanism source

Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.

The molecule

Antisense oligonucleotide

Olezarsen

Chemically modified antisense oligonucleotide conjugated to a ligand containing three GalNAc residues.

Shown: Olezarsen sodium as depicted in the prescribing information.

Exact chemical diagram from the label, including the GalNAc ligand. This single-strand antisense drug is distinct from a double-stranded siRNA; no 3D conformation is implied.

DailyMed Tryngolza label, sections 11 and 12.1

Development timeline

Next milestone

A next milestone is not summarized for this therapy. This does not mean development has ended.

Development history4 selected milestones

Olezarsen · compound history across indications

Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.

  1. Publication

    Early human APOC3 study published

    The phase 1/2a study of AKCEA-APOCIII-LRx, later named olezarsen, reported suppression of apoC-III and reductions in triglycerides and atherogenic lipoproteins in volunteers with elevated triglycerides.

    N-acetyl galactosamine-conjugated antisense drug to APOC3 mRNA, triglycerides and atherogenic lipoprotein levels — European Heart Journal (2019)
  2. Approval

    First FDA approval: FCS

    FDA approved Tryngolza for adults with familial chylomicronemia syndrome. This initial rare-disease indication is distinct from the moderate-triglyceride population in the plotted ESSENCE trial.

    FDA Drug Trials Snapshot: Tryngolza (olezarsen), original approval December 19, 2024
  3. Publication

    ESSENCE–TIMI 73b results published

    The plotted phase 3 trial reported substantial triglyceride lowering at six months in patients with moderate hypertriglyceridemia and elevated cardiovascular risk. It did not establish a reduction in cardiovascular events.

    Targeting APOC3 with Olezarsen in Moderate Hypertriglyceridemia — NEJM (2025)
  4. Approval

    FDA expands use to severe hypertriglyceridemia

    Ionis announced FDA approval as an adjunct to diet to reduce triglycerides and acute-pancreatitis risk in adults with severe hypertriglyceridemia, defined as triglycerides of at least 500 mg/dL.

    Ionis: Tryngolza FDA approval for severe hypertriglyceridemia (June 24, 2026)

Selected sources checked Sep 14, 2026. This is not an exhaustive history.