Tryngolza (autoinjector)

(Olezarsen)

Phase 3RNA therapy

Tryngolza (autoinjector) is one of 17 small molecule programs targeting Familial Chylomicronemia Syndrome. 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

Familial Chylomicronemia SyndromeActive, not recruiting

HypertriglyceridemiaCompleted

Familial Chylomicronemia SyndromePhase 3

Active, not recruiting

HypertriglyceridemiaPhase 3

Completed

Competition

Competitive Landscape

19 competitors in Hypertriglyceridemia

#DrugCompanyPhaseTrials

Cipro

Crestor

Selzentry

Lopid

Zocor

Topamax

Tryngolza (autoinjector)

Ionis Pharmaceuticals

Phase 3

3 8

Redemplo

Arrowhead Pharmaceuticals

Phase 3

3 9

SHR-1918

BBeijing Suncadia Pharmaceuticals Co., Ltd

Phase 3

1 10

Avandia

Jazz Pharmaceuticals

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

Q3 2031

Phase 3Recruiting

Familial Chylomicronemia Syndrome

NCT07727538

Clinical

Trials by Indication[1]

Familial Chylomicronemia Syndrome5 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

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

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

Approved for marketing· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals··NCT06360237

Show 2 more trials

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

An Open-Label Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Pediatric Patients With Familial Chylomicronemia Syndrome (FCS)

Recruiting· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT07727538·12 enrolled

Hypertriglyceridemia3 trials

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

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

Cardiovascular Disease2 trials

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

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

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 — 11 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

Q3 2031

Trials by Indication[1]

Familial Chylomicronemia Syndrome5 trials

Hypertriglyceridemia3 trials

Cardiovascular Disease2 trials

Adult1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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