Tryngolza (autoinjector)

(Olezarsen)

Phase 3RNA therapy

Tryngolza (autoinjector) is one of 83 small molecule programs targeting Cardiovascular Disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

HypertriglyceridemiaActive, not recruiting

Cardiovascular DiseasePhase 3

Active, not recruiting

HypertriglyceridemiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

274 competitors in Cardiovascular Disease

#DrugCompanyPhaseTrials

Colcrys

Alnylam Pharmaceuticals

Phase 3

1 2

Victoza

Novo Nordisk

Phase 3

1 3

Zocor

OOrganon and Co

Phase 3

2 4

Injectafer

AAmerican Regent, Inc.

Phase 3

1 5

Tryngolza (autoinjector)

Ionis Pharmaceuticals

Phase 3

2 6

Repatha

Amgen

Preclinical

5 7

Farxiga

AstraZeneca

Preclinical

1 8

Mounjaro

Eli Lilly

Preclinical

1 9

Praluent

Regeneron

Preclinical

1 10

Myrbetriq

Astellas

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Hypertriglyceridemia

NCT05681351

Q2 2027

Phase 3Active, not recruiting

Familial Chylomicronemia Syndrome

NCT05185843

Q1 2028

Phase 3Active, not recruiting

Familial Chylomicronemia Syndrome

NCT05130450

Clinical

Trials by Indication[1]

Familial Chylomicronemia Syndrome4 trials

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT04568434·66 enrolled

Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)

Approved for marketing· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals··NCT06360237

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)

Active, not recruiting· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT05130450·60 enrolled

Show 1 more trial

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen

Active, not recruiting· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT05185843·24 enrolled

Hypertriglyceridemia3 trials

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

Active, not recruiting· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT05681351·885 enrolled

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT05079919·617 enrolled

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT05552326·446 enrolled

Cardiovascular Disease2 trials

A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT05610280·1,478 enrolled

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 Hypertriglyceridemia

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 2·NCT05355402·154 enrolled

Adult1 trial

A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healthy Adult Participants

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 1·NCT05579860·104 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 19, 2024

TRYNGOLZA (AUTOINJECTOR)

NDA NDA218614

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Olezarsen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Olezarsen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Olezarsen. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218614). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Tryngolza (autoinjector). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Ionis Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: RNA therapy[2]
Highest Phase: Phase 3[1]
Company: Ionis Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Apr 27, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9157082Apr 27, 2032

9593333Feb 14, 2034

12509684May 1, 2034

9181549May 1, 2034

9163239May 1, 2034

Tryngolza (autoinjector)

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q1 2028

Trials by Indication[1]

Familial Chylomicronemia Syndrome4 trials

Hypertriglyceridemia3 trials

Cardiovascular Disease2 trials

Adult1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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