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Drug ReportsAbemaciclib
Verzenio, Verzenios(abemaciclib)
Verzenio, Verzenios (abemaciclib) is a small molecule pharmaceutical. Abemaciclib was first approved as Verzenio on 2017-09-28. It has been approved in Europe to treat breast neoplasms. It is known to target cyclin-dependent kinase 6 and cyclin-dependent kinase 4.
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Verzenio
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Abemaciclib
Tradename
Company
Number
Date
Products
VERZENIOEli LillyN-208716 RX2017-09-28
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
verzenioNew Drug Application2024-01-03
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
ABEMACICLIB, VERZENIO, ELI LILLY AND CO
2024-10-12I-877, NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Abemaciclib, Verzenio, Eli Lilly And Co
78552112029-12-15DS, DPU-1981, U-2132, U-2135, U-2251, U-3241, U-3242, U-3243, U-3265, U-3546
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EF: Cyclin-dependent kinase (cdk) inhibitors
— L01EF03: Abemaciclib
HCPCS
No data
Clinical
Clinical Trials
215 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5028391131079
Neoplasm metastasisD009362EFO_0009708—5231—10
Triple negative breast neoplasmsD064726——151118
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8019141—130
Prostatic neoplasmsD011471—C61462——9
Non-small-cell lung carcinomaD002289——631——9
Male breast neoplasmsD018567——113——5
LiposarcomaD008080———11——2
Urogenital neoplasmsD014565EFO_0003863D07——1——1
DiarrheaD003967HP_0002014R19.7——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Endometrial neoplasmsD016889EFO_0004230—26———7
Brain neoplasmsD001932EFO_0003833C7144———6
Castration-resistant prostatic neoplasmsD064129——23———4
GlioblastomaD005909EFO_0000515—22———4
Renal cell carcinomaD002292EFO_0000376—41———4
Colorectal neoplasmsD015179——42———4
Head and neck neoplasmsD006258———4———4
Squamous cell carcinoma of head and neckD000077195——14———4
Non-hodgkin lymphomaD008228—C85.921———3
Multiple myelomaD009101—C90.022———3
Show 36 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———8————8
Pancreatic neoplasmsD010190EFO_0003860C252————2
Primary myelofibrosisD055728—D47.42————2
GliomaD005910EFO_0000520—2————2
Myelodysplastic syndromesD009190—D461————1
Myeloid leukemia acuteD015470—C92.01————1
Hematologic neoplasmsD019337——1————1
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.01————1
B-cell chronic lymphocytic leukemiaD015451—C91.11————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAbemaciclib
INNabemaciclib
Description
Abemaciclib, sold under the brand name Verzenio among others, is a medication for the treatment of advanced or metastatic breast cancers. It was developed by Eli Lilly and it acts as a CDK inhibitor selective for CDK4 and CDK6.
Classification
Small molecule
Drug classcyclin dependent kinase inhibitors (formerly-cidib)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Identifiers
PDB—
CAS-ID1231929-97-7
RxCUI—
ChEMBL IDCHEMBL3301610
ChEBI ID—
PubChem CID46220502
DrugBankDB12001
UNII ID60UAB198HK (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CDK6
CDK6
CDK4
CDK4
Organism
Homo sapiens
Gene name
CDK6
Gene synonyms
CDKN6
NCBI Gene ID
Protein name
cyclin-dependent kinase 6
Protein synonyms
Cell division protein kinase 6, Serine/threonine-protein kinase PLSTIRE
Uniprot ID
Mouse ortholog
Cdk6 (12571)
cyclin-dependent kinase 6 (Q9R1D3)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Verzenio – Eli Lilly
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,616 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,354 adverse events reported
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