Taxotere(docetaxel)
Taxotere (docetaxel) is a small molecule pharmaceutical. Docetaxel was first approved as Taxotere on 1995-11-27. It is used to treat breast neoplasms, head and neck neoplasms, melanoma, non-small-cell lung carcinoma, and ovarian neoplasms amongst others in the USA. It has been approved in Europe to treat adenocarcinoma, adenoma, breast neoplasms, head and neck neoplasms, and non-small-cell lung carcinoma amongst others. The pharmaceutical is active against tubulin beta chain.
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Commercial
Trade Name
FDA
EMA
Taxotere (generic drugs available since 2014-11-05, discontinued: Docefrez)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Docetaxel
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DOCETAXEL | ACCORD HLTHCARE | N-201195 RX | 2012-04-20 | 3 products, RLD, RS |
| DOCETAXEL | Allergan | N-203551 RX | 2013-04-12 | 4 products |
| DOCETAXEL | Hospira | N-022234 RX | 2011-03-08 | 6 products, RLD, RS |
| DOCETAXEL | Meridian Laboratory | N-215813 PEND | 2022-11-22 | 3 products, RLD |
| DOCETAXEL | Sandoz | N-201525 RX | 2011-06-29 | 3 products |
| TAXOTERE | Sanofi | N-020449 RX | 2010-08-02 | 3 products, RLD, RS |
| DOCETAXEL | Shilpa Medicare | N-205934 RX | 2015-12-22 | 3 products, RLD, RS |
| DOCETAXEL | sparc | N-022534 RX | 2019-01-08 | 3 products |
Show 6 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| docetaxel | ANDA | 2023-06-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| head and neck neoplasms | — | D006258 | — |
| melanoma | — | D008545 | — |
| non-small-cell lung carcinoma | — | D002289 | — |
| ovarian neoplasms | EFO_0003893 | D010051 | C56 |
| pancreatic neoplasms | EFO_0003860 | D010190 | C25 |
| prostatic neoplasms | — | D011471 | C61 |
| soft tissue neoplasms | — | D012983 | — |
| stomach neoplasms | EFO_0003897 | D013274 | C16 |
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J9171 | Injection, docetaxel, 1 mg |
Clinical
Clinical Trials
2027 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 neoplasms | D001943 | EFO_0003869 | C50 | 61 | 247 | 141 | 17 | 21 | 454 |
| Non-small-cell lung carcinoma | D002289 | 71 | 214 | 100 | 6 | 8 | 355 | ||
| Prostatic neoplasms | D011471 | C61 | 71 | 172 | 47 | 1 | 9 | 266 | |
| Head and neck neoplasms | D006258 | 23 | 62 | 9 | 1 | — | 85 | ||
| Squamous cell neoplasms | D018307 | 5 | 27 | 5 | 1 | 1 | 32 | ||
| Male breast neoplasms | D018567 | 3 | 4 | 2 | 1 | — | 8 | ||
| Chemical and drug induced liver injury | D056486 | — | — | — | 1 | — | 1 | ||
| Second primary neoplasms | D016609 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 127 | 50 | 9 | — | 4 | 164 | |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 20 | 105 | 24 | — | 5 | 134 |
| Lung neoplasms | D008175 | C34.90 | 29 | 89 | 21 | — | 2 | 126 | |
| Squamous cell carcinoma of head and neck | D000077195 | 20 | 45 | 11 | — | 1 | 63 | ||
| Esophageal neoplasms | D004938 | C15 | 16 | 45 | 11 | — | 2 | 62 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 20 | 35 | 4 | — | 1 | 55 |
| Adenocarcinoma | D000230 | 7 | 41 | 9 | — | 1 | 53 | ||
| Castration-resistant prostatic neoplasms | D064129 | 13 | 23 | 8 | — | 2 | 39 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 10 | 31 | 1 | — | 2 | 39 |
| Sarcoma | D012509 | 13 | 23 | 3 | — | — | 33 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | 12 | 7 | — | — | 1 | 13 | ||
| Melanoma | D008545 | 8 | 7 | — | — | — | 12 | ||
| Biliary tract neoplasms | D001661 | C24.9 | — | 4 | — | — | 1 | 5 | |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 4 | 2 | — | — | — | 5 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 1 | 3 | — | — | 1 | 5 |
| Cholangiocarcinoma | D018281 | C22.1 | 1 | 5 | — | — | — | 5 | |
| Invasive hydatidiform mole | D002820 | D39.2 | 1 | 4 | — | — | — | 4 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 3 | — | — | 1 | 4 |
| Malignant pleural effusion | D016066 | J91.0 | — | 3 | — | — | — | 3 | |
| Hemangiosarcoma | D006394 | — | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 2 | — | — | — | — | 2 | |
| Hematologic neoplasms | D019337 | 2 | — | — | — | — | 2 | ||
| Colonic neoplasms | D003110 | C18 | 2 | — | — | — | — | 2 | |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 | |
| Chondrosarcoma | D002813 | 1 | — | — | — | — | 1 | ||
| Paraneoplastic syndromes | D010257 | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | — | — | — | — | 1 | 1 |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DOCETAXEL |
| INN | docetaxel |
| Description | Docetaxel anhydrous is a tetracyclic diterpenoid that is paclitaxel with the N-benzyloxycarbonyl group replaced by N-tert-butoxycarbonyl, and the acetoxy group at position 10 replaced by a hydroxy group. It has a role as an antineoplastic agent, a photosensitizing agent and an antimalarial. It is a tetracyclic diterpenoid and a secondary alpha-hydroxy ketone. It derives from a hydride of a taxane. |
| Classification | Small molecule |
| Drug class | antineoplastics, taxane derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)O[C@@]12CO[C@@H]1C[C@H](O)[C@@]1(C)C(=O)[C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C[C@@](O)([C@@H](OC(=O)c4ccccc4)[C@@H]12)C3(C)C.O.O.O |
Identifiers
| PDB | — |
| CAS-ID | 114977-28-5 |
| RxCUI | 1299922 |
| ChEMBL ID | CHEMBL3545252 |
| ChEBI ID | 59809 |
| PubChem CID | 148124 |
| DrugBank | DB01248 |
| UNII ID | 699121PHCA (ChemIDplus, GSRS) |
Target
Agency Approved
TUBB
TUBB
Organism
Homo sapiens
Gene name
TUBB
Gene synonyms
TUBB5
NCBI Gene ID
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
Mouse ortholog
Tubb5 (22154)
tubulin beta-5 chain (Q3UF52)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Docetaxel - Eagle Pharmaceuticals
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 77,257 documents
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Safety
Black-box Warning
Black-box warning for: Docetaxel
Adverse Events
Top Adverse Reactions
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405 adverse events reported
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