Selected approval record (2021-12-22): FDA approved inclisiran as an adjunct to diet and maximally tolerated statin therapy for adults with HeFH or clinical ASCVD who required additional LDL-C lowering.
Status in this atlas: Selected approval record (2021-12-22): FDA approved inclisiran as an adjunct to diet and maximally tolerated statin therapy for adults with HeFH or clinical ASCVD who required additional LDL-C lowering. Status source
Uses RNA interference to break down PCSK9 messenger RNA in liver cells, reducing PCSK9 production.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
Exact drug-specific chemical/sequence diagram from the label. This is a 2D representation, not a measured 3D RNA conformation. The linked label explains all abbreviations.
A next milestone is not summarized for this therapy. This does not mean development has ended.
Development history4 selected milestones
Inclisiran · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began.
Publication
Phase 1 RNA interference results
The early study of ALN-PCSsc, subsequently named inclisiran, reported sustained PCSK9 and LDL-C lowering after subcutaneous dosing. The date is the online publication, before the January 2017 journal issue.
The 501-participant dose-finding trial evaluated single-dose and two-dose regimens in people at high cardiovascular risk. LDL-C reductions supported the longer-interval dosing program.
The two pivotal trials reported approximately 50% LDL-C reductions with inclisiran. ORION-10 is the source trial for the lipid comparison plotted here; these were lipid-efficacy trials rather than dedicated cardiovascular-outcome trials.
FDA approved inclisiran as an adjunct to diet and maximally tolerated statin therapy for adults with HeFH or clinical ASCVD who required additional LDL-C lowering.
