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Ibrance(palbociclib)
Ibrance (palbociclib) is a small molecule pharmaceutical. Palbociclib was first approved as Ibrance on 2015-02-03. It is used to treat breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms. The pharmaceutical is active against cyclin-dependent kinase 4 and cyclin-dependent kinase 6.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Ibrance
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Palbociclib
Tradename
Company
Number
Date
Products
IBRANCEMylanN-207103 RX2015-02-03
3 products, RLD, RS
IBRANCEMylanN-212436 RX2019-11-01
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ibranceNew Drug Application2022-11-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Palbociclib, Ibrance, Pfizer
110652502036-05-24DP
107237302034-02-08DS, DP
RE477392027-03-05DS, DP
69366122023-01-16DS, DP
72084892023-01-16DS, DP
74561682023-01-16U-1998, U-2515, U-3501
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EF: Cyclin-dependent kinase (cdk) inhibitors
L01EF01: Palbociclib
HCPCS
No data
Clinical
Clinical Trials
299 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_0003869C50508519426165
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8012161227
Triple negative breast neoplasmsD0647263629
Male breast neoplasmsD01856723319
SarcomaD0125092518
Squamous cell carcinoma of head and neckD0000771952517
Squamous cell neoplasmsD01830712114
Squamous cell carcinomaD0022941112
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD0022896810
Pancreatic neoplasmsD010190EFO_0003860C25538
Ovarian neoplasmsD010051EFO_0003893C56268
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0717
Non-hodgkin lymphomaD008228C85.9246
Multiple myelomaD009101C90.0246
Colorectal neoplasmsD015179346
MelanomaD008545255
Head and neck neoplasmsD006258335
Myeloid leukemia acuteD015470C92.0414
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients1818
Castration-resistant prostatic neoplasmsD06412922
SyndromeD01357722
Myelodysplastic syndromesD009190D4611
Hematologic neoplasmsD01933711
Primary myelofibrosisD055728D47.411
B-cell chronic lymphocytic leukemiaD015451C91.111
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034011
Myelomonocytic leukemia chronicD015477C93.111
AnemiaD000740EFO_0004272D64.911
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RadiotherapyD01187811
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePALBOCICLIB
INNpalbociclib
Description
Palbociclib is a member of the class of pyridopyrimidines that is 2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7-one bearing additional methyl, acetyl and cyclopentyl substituents at positions 5, 6 and 8 respectively. It is used in combination with letrozole for the treatment of metastatic breast cancer. It has a role as an EC 2.7.11.22 (cyclin-dependent kinase) inhibitor and an antineoplastic agent. It is a pyridopyrimidine, an aminopyridine, a secondary amino compound, a member of piperidines, an aromatic ketone, a member of cyclopentanes and a tertiary amino compound.
Classification
Small molecule
Drug classcyclin dependent kinase inhibitors (formerly-cidib)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(=O)c1c(C)c2cnc(Nc3ccc(N4CCNCC4)cn3)nc2n(C2CCCC2)c1=O
Identifiers
PDB2EUF
CAS-ID571190-30-2
RxCUI1601374
ChEMBL IDCHEMBL189963
ChEBI ID85993
PubChem CID5330286
DrugBankDB09073
UNII IDG9ZF61LE7G (ChemIDplus, GSRS)
Target
Agency Approved
CDK4
CDK4
CDK6
CDK6
Organism
Homo sapiens
Gene name
CDK4
Gene synonyms
NCBI Gene ID
Protein name
cyclin-dependent kinase 4
Protein synonyms
Cell division protein kinase 4, PSK-J3
Uniprot ID
Mouse ortholog
Cdk4 (12567)
cyclin-dependent kinase 4 (P30285)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ibrance - Pfizer
$
£
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,767 documents
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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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