Olezarsen / Plozasiran (ApoC-III inhibitors)
Metabolic Health · ApoC-III inhibitor (antisense / siRNA)
Tier B
Bottom line
Read Off Label grades Olezarsen / Plozasiran (ApoC-III inhibitors) as B (6.8/10) based on strong evidence, high benefit magnitude, and a med-risk safety profile.
Olezarsen (Ionis/Sobi) approved in US and EU for familial chylomicronemia syndrome.
Studied, labeled, or reported-use context: Olezarsen 80 mg SC monthly; plozasiran SC quarterly — Rx (olezarsen approved US/EU for FCS as Tryngolza); severe HTG under FDA review; not individualized guidance.
What the evidence says
Olezarsen (Ionis/Sobi) approved in US and EU for familial chylomicronemia syndrome. sNDA for severe hypertriglyceridemia under FDA Priority Review, PDUFA June 30 2026: pooled CORE/CORE2 Phase 3 showed triglycerides -66% and acute pancreatitis events -85%. Plozasiran (Arrowhead) siRNA in Phase 3 (SHASTA) for the same population. Industry-sponsored. Fast-mover check Jul 27, 2026: the two Arrowhead plozasiran Phase 3 severe-hypertriglyceridaemia trials (NCT06347133, n=1,456; NCT06347003, n=446) passed their primary completion dates on Jun 1 and Jun 12, 2026 and are listed ACTIVE_NOT_RECRUITING — topline results are pending and are the next catalyst for this row. SHASTA-5 (NCT06880770) and the SHASTA-10 open-label extension (NCT06822790) continue recruiting into 2028-2029.
Mechanism
Hepatic apoC-III knockdown (olezarsen = antisense oligonucleotide; plozasiran = siRNA) de-represses lipoprotein lipase, accelerating triglyceride clearance, a route distinct from statins and fibrates.
Studied, labeled, or reported dose & route
Olezarsen 80 mg SC monthly; plozasiran SC quarterly
This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.
Citations
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Common questions
- What does the evidence show about Olezarsen / Plozasiran (ApoC-III inhibitors)'s effects?
- Read Off Label rates the evidence for Olezarsen / Plozasiran (ApoC-III inhibitors) as Strong and the benefit magnitude as high, producing an overall grade of B (6.8/10). Olezarsen (Ionis/Sobi) approved in US and EU for familial chylomicronemia syndrome.
- What safety findings are reported for Olezarsen / Plozasiran (ApoC-III inhibitors)?
- Olezarsen / Plozasiran (ApoC-III inhibitors) has a med risk profile in the database. Med (injection-site reactions; platelet monitoring) Legal status: Rx (olezarsen approved US/EU for FCS as Tryngolza); severe HTG under FDA review.
- What doses or routes are reported for Olezarsen / Plozasiran (ApoC-III inhibitors)?
- Olezarsen 80 mg SC monthly; plozasiran SC quarterly This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
- How does Olezarsen / Plozasiran (ApoC-III inhibitors) work?
- Hepatic apoC-III knockdown (olezarsen = antisense oligonucleotide; plozasiran = siRNA) de-represses lipoprotein lipase, accelerating triglyceride clearance, a route distinct from statins and fibrates.
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.