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Kisqali(ribociclib)
Kisqali (ribociclib) is a small molecule pharmaceutical. Ribociclib was first approved as Kisqali on 2017-03-13. 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.
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Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Kisqali
Combinations
Kisqali femara co-pack
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Letrozole
+
Ribociclib succinate
Tradename
Company
Number
Date
Products
KISQALI FEMARA CO-PACK (COPACKAGED)NovartisN-209935 RX2017-05-04
1 products, RLD, RS
Ribociclib succinate
Tradename
Company
Number
Date
Products
KISQALINovartisN-209092 RX2017-03-13
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
kisqali femara co-packNew Drug Application2022-05-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
Agency Specific
FDA
EMA
Expiration
Code
LETROZOLE / RIBOCICLIB SUCCINATE, KISQALI FEMARA CO-PACK (COPACKAGED), NOVARTIS
2024-12-10NPP
RIBOCICLIB SUCCINATE, KISQALI, NOVARTIS
2024-12-10NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Letrozole / Ribociclib Succinate, Kisqali Femara Co-Pack (Copackaged), Novartis
107995062036-04-14DP
91937322031-11-09DS, DP
98687392031-11-09U-1981, U-2355, U-2356, U-2505, U-3264, U-3265, U-3266
84153552031-03-13DS, DP
86859802030-05-25DS, DP
89626302029-12-09U-1981, U-2355, U-2356, U-2505, U-3264, U-3265, U-3266
94161362029-08-20U-1981, U-2355, U-2356, U-2505, U-3264, U-3265, U-3266
83242252028-06-17DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EF: Cyclin-dependent kinase (cdk) inhibitors
— L01EF02: Ribociclib
HCPCS
No data
Clinical
Clinical Trials
135 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_0003869C502227143764
NeoplasmsD009369C8097—1115
Triple negative breast neoplasmsD06472666—1—10
Male breast neoplasmsD0185671—11—3
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD00854513———4
NeuroblastomaD009447EFO_000062141———4
Non-small-cell lung carcinomaD00228941———4
SarcomaD01250913———4
Ovarian neoplasmsD010051EFO_0003893C5632———4
LiposarcomaD00808022———4
Diffuse intrinsic pontine gliomaD00008044331———3
Colorectal neoplasmsD01517931———3
Prostatic neoplasmsD011471C6122———2
Neuroendocrine tumorsD018358EFO_1001901D3A.8—2———2
Show 11 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_00005155————5
GliomaD005910EFO_00005205————5
Squamous cell carcinoma of head and neckD0000771954————4
MedulloblastomaD0085272————2
EpendymomaD0048062————2
PhenylketonuriasD010661E70.02————2
AstrocytomaD001254EFO_00002712————2
LymphomaD008223C85.92————2
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
Ovarian epithelial carcinomaD0000772161————1
Show 17 more
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRIBOCICLIB
INNribociclib
Description
Ribociclib, sold under the brand name Kisqali and Kryxana marketed by Novartis, is an inhibitor of cyclin D1/CDK4 and CDK6, and is used for the treatment of certain kinds of breast cancer. Ribociclib is a kinase inhibitor indicated in combination with: an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; or fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. It is also being studied as a treatment for other drug-resistant cancers. It was developed by Novartis and Astex Pharmaceuticals. Ribociclib is currently the only CDK4/6 inhibitor with a proven benefit on overall survival across all three Phase III trials of the MONALEESA clinical program with different endocrine therapy partners, regardless of menopausal status or line of therapy.[unreliable medical source?] The European Society of Medical Oncology (ESMO) assigned the highest score on the 'Magnitude of Clinical Benefit Scale' for Kisqali.[failed verification]
Classification
Small molecule
Drug classcyclin dependent kinase inhibitors (formerly-cidib)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN(C)C(=O)c1cc2cnc(Nc3ccc(N4CCNCC4)cn3)nc2n1C1CCCC1
Identifiers
PDB—
CAS-ID1211441-98-3
RxCUI1873916
ChEMBL IDCHEMBL3545110
ChEBI ID—
PubChem CID44631912
DrugBankDB11730
UNII IDTK8ERE8P56 (ChemIDplus, GSRS)
Target
Agency Approved
CDK4
CDK4
Organism
Homo sapiens
Gene name
CDK4
Gene synonyms
NCBI Gene ID
1019
Protein name
cyclin-dependent kinase 4
Protein synonyms
Cell division protein kinase 4, PSK-J3
Uniprot ID
Q6FG61
Mouse ortholog
Cdk4 (12567)
cyclin-dependent kinase 4 (P30285)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Kisqali - Novartis
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,348 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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91,681 adverse events reported
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