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Taxol, Paxene(paclitaxel)
Abraxane, Apealea (paclitaxel) is a small molecule pharmaceutical. Paclitaxel was first approved as Taxol on 1992-12-29. It is used to treat breast neoplasms, kaposi sarcoma, non-small-cell lung carcinoma, and ovarian neoplasms in the USA. It has been approved in Europe to treat breast neoplasms, kaposi sarcoma, non-small-cell lung carcinoma, ovarian neoplasms, and pancreatic neoplasms. The pharmaceutical is active against tubulin beta chain. In addition, it is known to target nuclear receptor subfamily 1 group I member 2 and toll-like receptor 4.
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BMS
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
Trade Name
FDA
EMA
Abraxane (generic drugs available since 2002-01-25, discontinued: Taxol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Paclitaxel
Tradename
Company
Number
Date
Products
PACLITAXELAmerican RegentN-211875 RX2022-07-27
1 products, RLD, RS
ABRAXANEBristol Myers SquibbN-021660 RX2005-01-07
1 products, RLD, RS
PACLITAXELTEVA PHARMS INCN-216338 RX2023-05-11
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
abraxaneNew Drug Application2020-09-03
paclitaxelNew Drug Application2023-05-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
kaposi sarcoma—D012514C46
non-small-cell lung carcinoma—D002289—
ovarian neoplasmsEFO_0003893D010051C56
Agency Specific
FDA
EMA
Expiration
Code
PACLITAXEL, ABRAXANE, BRISTOL-MYERS
2023-06-06PED
Patent Expiration
Patent
Expires
Flag
FDA Information
Paclitaxel, Abraxane, Bristol-Myers
95110462034-01-12U-1434
93933182032-03-04U-1290
95974092032-03-04U-1290
80343752026-08-13U-1290
77588912026-02-21U-1434
82683482026-02-21U-1290
91015432026-02-21U-1434
78207882024-10-27DPU-1092, U-1290, U-1434
79235362023-12-09U-1117, U-1290, U-1434
81382292023-12-09DPU-1092, U-1290, U-1434
83141562023-12-09U-1290, U-1434
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01C: Plant alkaloids and other natural products, antineoplastic drugs
— L01CD: Taxanes, antineoplastic
— L01CD01: Paclitaxel
— L01CD03: Paclitaxel poliglumex
HCPCS
Code
Description
J9264
Injection, paclitaxel protein-bound particles, 1 mg
J9267
Injection, paclitaxel, 1 mg
S1016
Non-pvc (polyvinyl chloride) intravenous administration set, for use with drugs that are not stable in pvc e.g., paclitaxel
Clinical
Clinical Trials
3604 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_0003869C501633971401640676
Non-small-cell lung carcinomaD002289112254121511455
Ovarian neoplasmsD010051EFO_0003893C561051727118319
NeoplasmsD009369C8025488934299
Pancreatic neoplasmsD010190EFO_0003860C2513418219314291
Lung neoplasmsD008175C34.90421134817188
Squamous cell carcinoma of head and neckD000077195215562176
Coronary artery diseaseD003324I25.1—918202365
AdenocarcinomaD000230194291461
Pancreatic ductal carcinomaD021441243371254
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Triple negative breast neoplasmsD0647264510030—1147
Fallopian tube neoplasmsD005185527239—2147
Stomach neoplasmsD013274EFO_0003897C16459621—6140
Esophageal neoplasmsD004938C15278027—5123
Uterine cervical neoplasmsD002583144129—583
Head and neck neoplasmsD00625824569—281
Esophageal squamous cell carcinomaD000077277105317—273
Endometrial neoplasmsD016889EFO_0004230253418——70
MelanomaD00854523377——59
Ovarian epithelial carcinomaD000077216242510—154
Show 100 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD0151791816——126
LymphomaD008223C85.9147———19
Liver neoplasmsD008113EFO_1001513C22.067——112
Transitional cell carcinomaD002295110———11
Uterine neoplasmsD014594EFO_0003859C55311———11
Non-hodgkin lymphomaD008228C85.983———10
CystadenocarcinomaD00353664———10
Central nervous system neoplasmsD01654356———9
HemangiosarcomaD006394—7———7
Thyroid neoplasmsD013964EFO_000384135———6
Show 88 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD0193375————5
Hodgkin diseaseD006689C814————4
Kidney diseasesD007674EFO_0003086N081———23
Myelodysplastic syndromesD009190D462————2
Myeloid leukemia acuteD015470C92.02————2
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.02————2
Myelomonocytic leukemia chronicD015477C93.12————2
Rectal neoplasmsD0120042————2
Follicular lymphomaD008224C822————2
Mucinous cystadenomaD0182911———12
Show 38 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.6————22
Type 2 diabetes mellitusD003924EFO_0001360E11————11
MedulloblastomaD008527————11
RetinoblastomaD012175————11
Primitive neuroectodermal tumorsD018242————11
HepatoblastomaD018197C22.2————11
Retinal neoplasmsD019572C69.2————11
PhenylketonuriasD010661E70.0————11
Breast diseasesD001941N60-N65————11
StrokeD020521EFO_0000712I63.9————11
Show 12 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePACLITAXEL
INNpaclitaxel
Description
Paclitaxel is a tetracyclic diterpenoid isolated originally from the bark of the Pacific yew tree, Taxus brevifolia. It is a mitotic inhibitor used in cancer chemotherapy. Note that the use of the former generic name 'taxol' is now limited, as Taxol is a registered trade mark. It has a role as a microtubule-stabilising agent, a metabolite, a human metabolite and an antineoplastic agent. It is a tetracyclic diterpenoid and a taxane diterpenoid. It is functionally related to a baccatin III.
Classification
Small molecule
Drug classantineoplastics, taxane derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(=O)O[C@H]1C(=O)[C@]2(C)[C@@H](O)C[C@H]3OC[C@@]3(OC(C)=O)[C@H]2[C@H](OC(=O)c2ccccc2)[C@]2(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Identifiers
PDB—
CAS-ID33069-62-4
RxCUI56946
ChEMBL IDCHEMBL428647
ChEBI ID45863
PubChem CID36314
DrugBankDB01229
UNII IDP88XT4IS4D (ChemIDplus, GSRS)
Target
Agency Approved
TUBB
TUBB
Organism
Homo sapiens
Gene name
TUBB
Gene synonyms
TUBB5
NCBI Gene ID
203068
Protein name
tubulin beta chain
Protein synonyms
beta Ib tubulin, epididymis secretory sperm binding protein, tubulin beta-1 chain, Tubulin beta-5 chain, tubulin, beta polypeptide
Uniprot ID
P07437
Mouse ortholog
Tubb5 (22154)
tubulin beta-5 chain (Q3UF52)
Alternate
NR1I2
NR1I2
TLR4
TLR4
Organism
Homo sapiens
Gene name
NR1I2
Gene synonyms
PXR
NCBI Gene ID
8856
Protein name
nuclear receptor subfamily 1 group I member 2
Protein synonyms
Orphan nuclear receptor PAR1, Orphan nuclear receptor PXR, Pregnane X receptor, Steroid and xenobiotic receptor, SXR
Uniprot ID
Q9UNW4
Mouse ortholog
Nr1i2 (18171)
nuclear receptor subfamily 1 group I member 2 (O54915)
Variants
Clinical Variant
No data
Financial
Abraxane - Bristol Myers Squibb
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Abraxane - Celgene
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 147,582 documents
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Safety
Black-box Warning
Black-box warning for: Abraxane, Paclitaxel
Adverse Events
Top Adverse Reactions
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1,680 adverse events reported
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