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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Commercial
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 |
---|---|---|---|---|
VERZENIO | Eli Lilly | N-208716 RX | 2017-09-28 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
verzenio | New Drug Application | 2020-09-28 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
ABEMACICLIB, VERZENIO, ELI LILLY AND CO | |||
2024-10-12 | I-877, NPP |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Abemaciclib, Verzenio, Eli Lilly And Co | |||
7855211 | 2029-12-15 | DS, DP | U-1981, U-2132, U-2135, U-2251, U-3241, U-3242, U-3243, U-3265, U-3546 |
HCPCS
No data
Clinical
Clinical Trials
173 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 neoplasms | D001943 | EFO_0003869 | C50 | 26 | 35 | 10 | 3 | 6 | 69 |
Neoplasm metastasis | D009362 | EFO_0009708 | 5 | 2 | 3 | 1 | — | 10 | |
Triple negative breast neoplasms | D064726 | 1 | 4 | 1 | 1 | — | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Endometrial neoplasms | D016889 | EFO_0004230 | 2 | 5 | — | — | — | 7 | |
Brain neoplasms | D001932 | EFO_0003833 | C71 | 4 | 4 | — | — | — | 6 |
Colorectal neoplasms | D015179 | 5 | 2 | — | — | — | 5 | ||
Castration-resistant prostatic neoplasms | D064129 | 2 | 3 | — | — | — | 4 | ||
Glioblastoma | D005909 | EFO_0000515 | 2 | 2 | — | — | — | 4 | |
Squamous cell carcinoma of head and neck | D000077195 | 1 | 4 | — | — | — | 4 | ||
Non-hodgkin lymphoma | D008228 | C85.9 | 2 | 1 | — | — | — | 3 | |
Multiple myeloma | D009101 | C90.0 | 2 | 2 | — | — | — | 3 | |
Renal cell carcinoma | D002292 | 3 | 1 | — | — | — | 3 | ||
Adenocarcinoma | D000230 | 2 | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 8 | — | — | — | — | 8 | ||
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | — | — | — | — | 3 |
Primary myelofibrosis | D055728 | D47.4 | 2 | — | — | — | — | 2 | |
Glioma | D005910 | EFO_0000520 | 2 | — | — | — | — | 2 | |
Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_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 name | ABEMACICLIB |
INN | abemaciclib |
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 class | cyclin dependent kinase inhibitors (formerly-cidib) |
Image (chem structure or protein) | |
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-ID | 1231929-97-7 |
RxCUI | 1946825 |
ChEMBL ID | CHEMBL3301610 |
ChEBI ID | — |
PubChem CID | 46220502 |
DrugBank | DB12001 |
UNII ID | 60UAB198HK (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Variants
Clinical Variant
No data
Financial
Verzenio - Eli Lilly
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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