statistically significant mean change in fasting triglycerides compared with placebo at Month 6* (P<0.0001)1
TRYNGOLZA, a designated breakthrough therapy, demonstrated significant fasting triglyceride level reductions compared with placebo at Month 61,2
The efficacy and safety of TRYNGOLZA 50 mg and 80 mg were evaluated in 2 randomized, double-blind, placebo-controlled, phase 3 clinical trials (CORE and CORE2), which included 1061 adults with sHTG (triglyceride levels ≥500 mg/dL). The primary endpoint was mean percent change in fasting triglycerides from baseline to Month 6* compared with placebo.1,3
Primary endpoint
Up to -72%
statistically significant mean change in fasting triglycerides compared with placebo at Month 6* (P<0.0001)1
Select secondary endpoint
(for pooled TRYNGOLZA group)
-85%
change in the adjudicated acute pancreatitis event rate compared with the pooled placebo group at Month 12
(RR: 0.15; 95% CI: 0.05, 0.40)1†
Adverse reactions
The most common adverse reactions (incidence ≥2% higher than placebo) were injection-site reactions and liver enzyme increases1
Average of Weeks 25 and 27.1
Pancreatitis events were assessed as a secondary endpoint in an integrated analysis of CORE and CORE2. Events were adjudicated by a blinded, independent committee according to the Revised Atlanta Diagnostic Criteria. Time to first event was compared between pooled TRYNGOLZA (50 mg and 80 mg) and pooled placebo using a log-rank test stratified by trial. Event rates over 53 weeks were compared between pooled TRYNGOLZA (50 mg and 80 mg) and pooled placebo using a negative binomial regression model.1
RR=rate ratio.
Get your patients started on TRYNGOLZA
e-Prescribe TRYNGOLZA through your electronic health record (EHR) system to:
e-Prescribe TRYNGOLZA through your electronic health record (EHR) system to an in-network digital pharmacy (BlinkRx) or specialty pharmacy (Accredo, CVS Specialty, Optum Specialty Pharmacy)
Download the TRYNGOLZA Start Form and fax the completed form to:
Download the TRYNGOLZA Start Form and fax the completed form to an in-network digital pharmacy (BlinkRx) or specialty pharmacy (Accredo, CVS Specialty, Optum Specialty Pharmacy)
An in-network digital pharmacy (BlinkRx) or specialty pharmacy (Accredo, CVS Specialty, Optum Specialty Pharmacy)
TRYNGOLZA is available through a select pharmacy network
Use of a specific pharmacy may be required by some insurance plans or pharmacy benefit managers (PBMs), so it is important to confirm with the patient’s plan prior to sending the prescription.
| Pharmacy | Phone | Fax |
|---|---|---|
| Accredo | 1-844-516-3319 | 1-888-302-1028 |
| BlinkRx | 1-844-926-2480 | 1-866-585-4631 |
| CVS Specialty | 1-800-237-2767 | 1-800-323-2445 |
| Optum Specialty Pharmacy | 1-855-427-4682 | 1-877-342-4596 |
Ionis Every Step™ is a support program designed to help your patients navigate treatment with TRYNGOLZA
Ionis Every Step offers a broad range of support for patients at every step of their treatment journey.
Help your patients take the next step with Ionis Every Step.
Encourage patients to enroll today by visiting TRYNGOLZA.com/Enroll, or if your patient needs additional support, they can call the Ionis Every Step TRYNGOLZA Support Center at 1-844-789-8744 (select option 2), Monday to Friday, 8 AM to 8 PM ET.
TRYNGOLZA® (olezarsen) is contraindicated in patients with a history of serious hypersensitivity to TRYNGOLZA or any of the excipients in TRYNGOLZA. Hypersensitivity reactions requiring medical treatment have occurred.
Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias) have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur.
TRYNGOLZA can cause increases in liver enzymes and hepatic fat in adults. Increases in liver enzymes were more frequently reported with the 80 mg dose as compared with the 50 mg dose. Consider liver enzyme testing before TRYNGOLZA initiation or an increase in dosage and when clinically indicated thereafter. If persistent elevations in liver enzymes occur, consider dose interruption and/or dose reduction. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue TRYNGOLZA.
Adverse Reactions for FCS
Most common adverse reactions in patients with FCS (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count, and arthralgia.
Adverse Reactions for sHTG
Most common adverse reactions in patients with sHTG (incidence ≥2% higher than placebo) were injection site reactions and liver enzyme increases.
Familial Chylomicronemia Syndrome (FCS)
TRYNGOLZA (olezarsen) is indicated as an adjunct to diet to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS).
Severe Hypertriglyceridemia (sHTG)
TRYNGOLZA is indicated as an adjunct to diet to reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG ≥500 mg/dL).
Please see full Prescribing Information for TRYNGOLZA.
References: 1. TRYNGOLZA. Prescribing information. Ionis Pharmaceuticals. 2. Ionis receives U.S. FDA Breakthrough Therapy designation for olezarsen for severe hypertriglyceridemia (sHTG). News release. Ionis Pharmaceuticals. December 1, 2025. Accessed March 3, 2026. https://ir.ionis.com/news-releases/news-release-details/ionis-receives-us-fda-breakthrough-therapy-designation-olezarsen 3. Marston NA, Bergmark BA, Alexander VJ, et al. Olezarsen for managing severe hypertriglyceridemia and pancreatitis risk. N Engl J Med. 2026;394(5):429-441.