CDEK
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inclisiran

Trade name: Leqvio

Small moleculeapproved

Approved

Dec 22, 2021

Inclisiran, sold under the brand name Leqvio, is a medication used for the treatment of high low-density lipoprotein (LDL) cholesterol and for the treatment of people with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk-equivalents, and heterozygous familial hypercholesterolemia (HeFH). It is a small interfering RNA (siRNA) that acts as an inhibitor of a proprotein convertase, specifically, inhibiting translation of the protein PCSK9. — Wikipedia

Clinical trial activity

46 trials · 24 clinical orgs · 1 marketing orgs

Phase 1
3
Phase 2
27
Phase 3
24
Phase 4
13

Earliest trial started Dec 1, 2014 (NCT02314442)

Timeline

2010s

  1. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2017

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Dec 22, 2021

    Novartis — Earliest FDA Approval

  2. Dec 22, 2021

    Novartis — Marketing Organization

  3. Dec 22, 2021

    Novartis — NDA Secondary Org

  4. Dec 22, 2021

    Novartis — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 22, 2021

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • aln-pcs
  • aln-pcssc
  • aln-pcssc
  • inclisiran
  • inclisiran
  • inclisiran

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07102628Phase 3Sep 30, 2025Novartis
NCT06909565Phase 4Jul 23, 2025Colorado Prevention Center, Duke University, Icahn School of Medicine at Mount Sinai, Novartis
NCT06941792Phase 4Jun 17, 2025Novartis
NCT06813911Phase 3May 28, 2025Novartis
NCT06597006Phase 3Mar 31, 2025Novartis
NCT06597019Phase 3Mar 31, 2025Novartis
NCT06865885Phase 4Mar 30, 2025Novartis, University of California, San Diego
NCT06791031N/AJan 31, 2025Sichuan University
NCT06249165Phase 4Nov 30, 2024Duke University, Novartis
NCT06501443Phase 4Nov 29, 2024Novartis
NCT06386419Phase 4Oct 30, 2024Novartis
NCT06586684Phase 4Sep 20, 2024Xinjiang Medical University
NCT06494501Phase 3Jul 31, 2024Icahn School of Medicine at Mount Sinai
NCT06372925Phase 4Jul 12, 2024Novartis
NCT06431763Phase 4Jun 21, 2024Novartis
NCT06421363Phase 4Jun 1, 2024University of Santiago de Compostela
NCT05587621N/AApr 1, 2024Friedrich Schiller University, University of Jena
NCT06338293Phase 4Mar 31, 2024Nanjing Medical University
NCT05834673Phase 4Nov 17, 2023Monash University, Novartis
NCT05888103Phase 3Jul 11, 2023Novartis
Showing 20 of 46 trials
Page 1 / 3

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit282442021
The Medicines CompanyFor profit11932014
Duke UniversityAcademic/Hospital2212024
Icahn School of Medicine at Mount SinaiAcademic/Hospital2122024
Mayo ClinicAcademic/Hospital2012017
University of LondonAcademic/Hospital2022016
Alnylam PharmaceuticalsFor profit1112014
Colorado Prevention CenterAcademic/Hospital1012025
Friedrich Schiller UniversityAcademic/Hospital1112024
LIB Therapeutics LLCFor profit1112021
Medpace, Inc.For profit1012021
Monash UniversityAcademic/Hospital1112023
Nanjing Medical UniversityAcademic/Hospital1112024
Sichuan UniversityAcademic/Hospital1112025
The FH FoundationAcademic/Hospital1012019
The TIMI Study GroupAcademic/Hospital1012018
University of AmsterdamAcademic/Hospital1012016
University of California, San DiegoAcademic/Hospital1112025
University of JenaAcademic/Hospital1012024
University of OtagoAcademic/Hospital1012017
24 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
NovartisFor profitSYNDec 22, 2021
NovartisFor profitMKTGDec 22, 2021
NovartisFor profitNDA2Dec 22, 2021
NovartisFor profitNDADec 22, 2021