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abemaciclib

Trade name: verzenio

Small moleculeapprovedFast Track FDABreakthrough Therapy FDA

Approved

Sep 28, 2017

Abemaciclib, previously known as LY2835219, is a potent and selective inhibitor of cyclin-dependent kinases: CDK4 and CDK6, developed by Eli Lilly, which is in clinical trial phase III for the treatment of breast cancer and non-small cell lung cancer (NSCLC) and in phase II for investigation of its treatment glioblastoma and melanoma. — NCATS

Clinical trial activity

207 trials · 143 clinical orgs · 2 marketing orgs

Phase 1
80
Phase 2
141
Phase 3
25
Phase 4
6

Earliest trial started Dec 7, 2009 (NCT01394016)

Timeline

2000s

  1. Jan 1, 2009

    Eli Lilly — Earliest Phase 1 Sponsor(trial)

  2. Sep 15, 2009

    Eli Lilly — IND Organization

  3. Sep 15, 2009

    Eli Lilly — IND Organization

2010s

  1. Jan 1, 2013

    Eli Lilly — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2014

    Eli Lilly — Earliest Phase 3 Sponsor(trial)

  3. Sep 28, 2017

    Eli Lilly — Earliest FDA Approval

  4. Sep 28, 2017

    Eli Lilly — NDA Secondary Org

  5. Sep 28, 2017

    Eli Lilly — NDA Organization

2020s

  1. Nov 6, 2025

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackBreakthroughSep 28, 2017

Chemistry & pharmacology

Loading structure…

SMILES

CCN1CCN(CC2=CN=C(NC3=NC=C(F)C(=N3)C4=CC5=C(N=C(C)N5C(C)C)C(F)=C4)C=C2)CC1
Mol. weight
506.5934 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 5-(4-ethylpiperazin-1-ylmethyl)pyridin-2-yl)-(5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3h-benzimidazol-5-yl)pyrimidin-2-yl)amine
  • 5-(4-ethylpiperazin-1-ylmethyl)pyridin-2-yl)-(5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3h-benzoimidazol-5-yl)pyrimidin-2-yl)amine
  • abemaciclib
  • abemaciclib
  • abemaciclib
  • abemaciclib
  • abemaciclib
  • abemaciclib
  • abemaciclib
  • ly2385219
  • ly2835210
  • ly2835219
  • ly2835219
  • ly2835219
  • ly2835219
  • ly-2835219
  • ly-2835219

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07191717Phase 2Apr 30, 2026University of California, Los Angeles
NCT07292207Phase 2Jan 10, 2026Aichi Medical University, Japanese Foundation for Cancer Research, Nagoya City University, National Cancer Center, Japan, Tohoku University, University of Tsukuba
NCT07174336Phase 3Oct 27, 2025Eli Lilly, Pfizer
NCT07100106Phase 1/Phase 2 (Phase 2)Oct 7, 2025Genentech, Roche
NCT07209449Phase 2Oct 1, 2025Memorial Sloan-Kettering Cancer Center
NCT07002177Phase 1/Phase 2 (Phase 2)Jun 1, 2025Forward Pharmaceuticals Co., Ltd.
NCT06585969Phase 3May 1, 2025Danish Breast Cancer Cooperative Group
NCT06810492N/AApr 1, 2025Wuhan University
NCT06810544Phase 1/Phase 2 (Phase 2)Mar 24, 2025Eli Lilly, Tango Therapeutics, Inc.
NCT06813079Phase 2Feb 17, 2025University of Toronto
NCT06835972Phase 1/Phase 2 (Phase 2)Feb 14, 2025Eli Lilly, Exelixis, Memorial Sloan-Kettering Cancer Center
NCT07190443Phase 3Feb 7, 2025Japan Clinical Oncology Group, Japanese Foundation for Cancer Research
NCT06498648Phase 1/Phase 2 (Phase 2)Jan 19, 2025National Cancer Institute (NCI), University of Texas at Houston
NCT06760637Phase 3Jan 6, 2025Pfizer
NCT06630325Phase 2Jan 1, 2025AstraZeneca, Eli Lilly, OHSU Knight Cancer Institute, Oregon Health and Science University
NCT06678269Phase 1Nov 30, 2024Eli Lilly, Memorial Sloan-Kettering Cancer Center
NCT06959979Early Phase 1 (Phase 1)Nov 25, 2024Universita' Cattolica del Sacro Cuore
NCT06654037Phase 1Nov 22, 2024National Cancer Institute (NCI), University of Pittsburgh
NCT06699472Phase 2Oct 31, 2024Fudan University
NCT06413706Phase 2Oct 28, 2024Eli Lilly
Showing 20 of 207 trials
Page 1 / 11

Organizations

Research & Development (143)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Eli LillyFor profit1065752009
Harvard UniversityAcademic/Hospital171522017
National Cancer Institute (NCI)Government17922019
AstraZenecaFor profit7432018
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital7632017
Fudan UniversityAcademic/Hospital5522022
RocheFor profit5322017
GenentechFor profit4112019
PfizerFor profit4222018
University of Texas at HoustonAcademic/Hospital4312018
MerckFor profit3022014
University of ArizonaAcademic/Hospital3222020
University of PennsylvaniaAcademic/Hospital3312019
University of WashingtonAcademic/Hospital3322019
Barrow Neurological InstituteAcademic/Hospital2122020
CelgeneFor profit2012017
Chao Family Comprehensive Cancer CenterAcademic/Hospital2012020
Cornell UniversityAcademic/Hospital2222016
Emory UniversityAcademic/Hospital2212016
Ivy Brain Tumor CenterAcademic/Hospital2022020
143 organizations
Page 1 / 8

Marketing (4)

OrganizationOrg typeRelationshipDate
Eli LillyFor profitNDA2Sep 28, 2017
Eli LillyFor profitNDASep 28, 2017
Eli LillyFor profitINDSep 15, 2009
Qilu Pharmaceutical Co., Ltd.For profitMKTGNov 6, 2025