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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
NeoplasmsD009369C8012161—227
Triple negative breast neoplasmsD064726362——9
Male breast neoplasmsD018567233—19
SarcomaD012509251——8
Squamous cell carcinoma of head and neckD000077195251——7
Squamous cell neoplasmsD018307121—14
Squamous cell carcinomaD002294—11—12
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD00228968———10
Pancreatic neoplasmsD010190EFO_0003860C2553———8
Ovarian neoplasmsD010051EFO_0003893C5626———8
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.071———7
Non-hodgkin lymphomaD008228C85.924———6
Multiple myelomaD009101C90.024———6
Colorectal neoplasmsD01517934———6
MelanomaD00854525———5
Head and neck neoplasmsD00625833———5
Myeloid leukemia acuteD015470C92.041———4
Show 55 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—18————18
Castration-resistant prostatic neoplasmsD0641292————2
SyndromeD0135772————2
Myelodysplastic syndromesD009190D461————1
Hematologic neoplasmsD0193371————1
Primary myelofibrosisD055728D47.41————1
B-cell chronic lymphocytic leukemiaD015451C91.11————1
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003401————1
Myelomonocytic leukemia chronicD015477C93.11————1
AnemiaD000740EFO_0004272D64.91————1
Show 20 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RadiotherapyD011878————11
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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