Plozasiran PALISADE Phase 3 FCS Topline
Phase 3 efficacy readout for Arrowhead’s wholly-owned plozasiran (APOC3 siRNA) in familial chylomicronemia syndrome (FCS). Same indication: Ionis’s olezarsen (PDUFA 2026-12-19). Watch: triglyceride reduction at month 12, acute pancreatitis events.
What’s at stake
Plozasiran is a quarterly subcutaneous RNAi therapy developed by Arrowhead Pharmaceuticals that silences the APOC3 gene in liver cells to dramatically reduce apolipoprotein C-III (ApoC-III) — a protein that inhibits the triglyceride-clearing enzyme lipoprotein lipase. In familial chylomicronemia syndrome (FCS), biallelic LPL mutations make patients genetically unable to clear dietary fat, producing triglyceride levels that can exceed 1,000 mg/dL and recurrent life-threatening pancreatitis attacks; ApoC-III suppression restores the patient's residual triglyceride clearance capacity. Plozasiran is in a Phase 3 pivotal trial (PALISADE) for FCS, competing directly with Ionis's olezarsen in the same indication.
No primer in glossary yet.
- siRNAmodalitySmall interfering RNA
RNA-based drug that silences a target gene by triggering mRNA degradation. Hepatic gene silencing is the dominant use case.
- PDUFAregulatoryPrescription Drug User Fee Act
The FDA's self-imposed review deadline for an NDA/BLA. Standard reviews are ~10 months from filing; priority reviews are ~6 months.
of 2 historical Phase 3 readouts in Cardio-Renal: 1 positive, 1 mixed, 0 negative.
How Ph3 readouts in Cardio-Renal have landed.
Reference, not prediction. We surface the historical record so you can read it yourself. We never extrapolate to the upcoming event.
Competitive landscape
| Drug | Company | Modality | Mechanism | Phase | Next catalyst |
|---|---|---|---|---|---|
| olezarsen | IONS | oligonucleotide | ApoCIII antisense oligonucleotide | PDUFA · Dec 26 | |
| AMVUTTRAvutrisiran | ALNY | siRNA | TTR-targeting RNAi | PDUFA · Dec 26 | |
| VERVE-102 | VERV | gene therapy | LNP-delivered base editor targeting PCSK9 | INTERIM · Nov 26 | |
| XPHOZAHtenapanor | ARDX | small molecule | NHE3 inhibitor | CMC · Jul 26 |
Prior ARWR reactions to Readout events
| Date | Headline | Outcome | 1W | 1M | 6M |
|---|---|---|---|---|---|
| Sep 2024 | plozasiran — Phase 3 Topline — Mixed Result | negative | -16.7% | -26.2% | -42.7% |
Disclosure trail
- Apr 21, 2026·9d agopinned · highest confidenceHIGH confPRQTRtop claimQ1'27
“PALISADE, the Phase 3 study of plozasiran in familial chylomicronemia syndrome, is expected to deliver topline data in Q1 2027.”
conf 85%via llm