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Trilaciclib
Cosela (trilaciclib) is a small molecule pharmaceutical. Trilaciclib was first approved as Cosela on 2021-02-12. It is known to target cyclin-dependent kinase 4, cyclin-dependent kinase 6, cyclin-dependent kinase 7, cyclin-dependent kinase 9, and cyclin-dependent kinase 2.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Cosela
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Trilaciclib dihydrochloride
Tradename
Company
Number
Date
Products
COSELAG1 TherapeuticsN-214200 RX2021-02-12
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
coselaNew Drug Application2021-02-22
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
TRILACICLIB DIHYDROCHLORIDE, COSELA, G1 THERAP
2026-02-12NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Trilaciclib Dihydrochloride, Cosela, G1 Therap
115293522039-07-23U-3504
94875302034-03-14U-3079, U-3080
100859922034-03-14U-3081
109669842034-03-14U-3079, U-3080
110400422034-03-14DP
85981862031-10-25DS, DP
85981972031-10-25DS, DP
99572762031-10-25DP
101898492031-10-25DP
101898502031-10-25DP
109271202031-10-25DP
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AF: Detoxifying agents for antineoplastic treatment
— V03AF12: Trilaciclib
HCPCS
Code
Description
J1448
Injection, trilaciclib, 1mg
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Triple negative breast neoplasmsD064726—41——5
Breast neoplasmsD001943EFO_0003869C50—31——4
Colorectal neoplasmsD015179——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Small cell lung carcinomaD05575224——15
Lung neoplasmsD008175C34.90—2———2
HemangiosarcomaD006394—1———1
Non-small-cell lung carcinomaD002289—1———1
Urologic neoplasmsD014571C64-C68—1———1
Urinary bladder neoplasmsD001749C67—1———1
Chemotherapy-induced febrile neutropeniaD064146—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTRILACICLIB
INNtrilaciclib
Description
Trilaciclib, sold under the brand name Cosela, is a medication used to reduce the frequency of chemotherapy-induced bone marrow suppression.
Classification
Small molecule
Drug classcyclin dependent kinase inhibitors (formerly-cidib)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1CCN(c2ccc(Nc3ncc4cc5n(c4n3)C3(CCCCC3)CNC5=O)nc2)CC1
Identifiers
PDB—
CAS-ID1374743-00-6
RxCUI—
ChEMBL IDCHEMBL3894860
ChEBI ID—
PubChem CID68029831
DrugBankDB15442
UNII IDU6072DO9XG (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CDK4
CDK4
CDK6
CDK6
CDK7
CDK7
CDK9
CDK9
CDK2
CDK2
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)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 200 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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15 adverse events reported
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