Drug · Small Molecule

Abemaciclib

CI-DRUG-00000033Explore in graph →NCIt C97660 CHEMBL3301610 CIViC Approved

Regulatory

Approvals (18)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory13 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-09-18 (see label)	approved	Sep 18, 2026	openfda
US FDA	—	Efficacy supplement 2026-07-13 (see label)	approved	Jul 13, 2026

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	103	60	21	186	18	CA, EU, US	Sep 28, 2017	Dec 7, 2009
Malignant Breast Neoplasm	Approved	Phase 4	42	27	7	73	5	EU, US	Sep 28, 2017	Jul 31, 2012
Malignant Lung Neoplasm	Phase3	Phase 3	4	1	1	12	0	—	—	Jul 31, 2012
Malignant Prostate Neoplasm	Phase3	Phase 3	2	1	1	8

Curated evidence

Clinical evidence (5)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–5 of 5 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
KRAS A146V1
Abemaciclib	Lung Non-Small Cell Carcinoma

Clinical trials

Trials with this intervention (195)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 195 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03994796	Genetic Testing in Guiding Treatment for Patients With Brain Metastases	active not recruiting	Phase 2	50	Alliance for Clinical Trials in OncologyOTHER	1	Sep 28, 2026	clinicaltrials
NCT04923542	SRS & Abemaciclib w/wo Imlunestrant in the Management of HR+/HER2- Breast CA Brain Metastases	recruiting	Phase 1 / Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: Cyclin-dependent kinase 4 inhibitor; Cyclin-dependent kinase 6 inhibitor
Targets: 2 genes
UNII: 60UAB198HK
Aliases: 2-Pyrimidinamine, N-(5-((4-ethyl-1-piperazinyl)methyl)-2-pyridinyl)-5-fluoro-4-(4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl), Abemaciclib, ABEMACICLIB (LY2835219), CDK4/6 DUAL INHIBITOR, LY 2835219, LY-2835219, LY2835219, LY-28352192-PYRIMIDINAMINE, LY2835219 FREE BASE, N-[5-[(4-ETHYL-1-PIPERAZINYL)METHYL]-2-PYRIDINYL]-5-FLUORO-4-[4-FLUORO-2-METHYL-1-(1-METHYLETHYL)-1H-BENZIMIDAZOL-6-YL]-, Verzenio, VERZENIO, Verzenios, VERZENIOS

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (10)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EF03	ABEMACICLIB
DIN (Health Canada)	02487098

SMARCA4 Loss2
Abemaciclib + PalbociclibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID7155 Preclinical evidence showing that SMARCA4 inactivation results in downregulation of Cyclin D1 in NSCLC cells and confers sensitivity of such to CDK4/6 inhibitors. SMARCA4 loss is synthetic letha with … (full text at CIViC) PMID 30718506 · Xue et al., 2019 · Open in CIViC	civic
Abemaciclib + Palbociclib + RibociclibSubstitutes	Ovarian Small Cell Carcinoma	Predictive	D	Supports Sensitivity Response	4	submitted	EID7154 Inactivating mutations in SMARCA4 underlie small cell carcinoma of the ovary, hypercalcemic type (SCCOHT). The authors show that loss of SMARCA4 leads to downregulation of Cyclin D1 and deficient cell… (full text at CIViC) PMID 30718512 · Xue et al., 2019 · Open in CIViC	civic