Taxol, Paxene(paclitaxel)
Abraxane, Apealea, Paclitaxel, Pazenir (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 toll-like receptor 4 and nuclear receptor subfamily 1 group I member 2.
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Commercial
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Abraxane, Paclitaxel (discontinued: Paclitaxel, 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 |
|---|---|---|---|---|
| PACLITAXEL | American Regent | N-211875 RX | 2022-07-27 | 1 products, RLD, RS |
| ABRAXANE | Bristol Myers Squibb | N-021660 RX | 2005-01-07 | 1 products, RLD, RS |
| PACLITAXEL | Teva | N-216338 RX | 2023-05-11 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| abraxane | New Drug Application | 2022-10-31 |
| paclitaxel | ANDA | 2025-04-08 |
| paclitaxel injection, | ANDA | 2009-07-02 |
| paclitaxel protein bound particles albumin bound | New Drug Application | 2023-05-31 |
| paclitaxel protein-bound particles for injectable suspension (albumin-bound) | NDA authorized generic | 2022-04-01 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
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Clinical
Clinical Trials
5530 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 | 235 | 662 | 249 | 27 | 124 | 1170 |
| Non-small-cell lung carcinoma | D002289 | — | — | 188 | 462 | 196 | 10 | 37 | 805 |
| Lung neoplasms | D008175 | — | C34.90 | 153 | 417 | 163 | 9 | 37 | 702 |
| Carcinoma | D002277 | — | C80.0 | 151 | 415 | 104 | 5 | 33 | 641 |
| Neoplasms | D009369 | — | C80 | 381 | 204 | 28 | 4 | 35 | 557 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 144 | 262 | 127 | 3 | 39 | 518 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 193 | 286 | 43 | 3 | 45 | 474 |
| Adenocarcinoma | D000230 | — | — | 127 | 255 | 83 | 3 | 29 | 420 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 102 | 184 | 101 | 3 | 28 | 382 |
| Squamous cell carcinoma | D002294 | — | — | 65 | 261 | 53 | 4 | 24 | 370 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fallopian tube neoplasms | D005185 | — | — | 61 | 92 | 58 | — | 7 | 196 |
| Uterine cervical neoplasms | D002583 | — | — | 22 | 85 | 46 | — | 21 | 158 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 39 | 63 | 31 | — | 5 | 126 |
| Head and neck neoplasms | D006258 | — | — | 38 | 85 | 12 | — | 3 | 120 |
| Peritoneal neoplasms | D010534 | — | — | 35 | 47 | 29 | — | 5 | 108 |
| Melanoma | D008545 | — | — | 33 | 55 | 11 | — | 1 | 84 |
| Urinary bladder neoplasms | D001749 | — | C67 | 22 | 50 | 8 | — | 2 | 70 |
| Small cell lung carcinoma | D055752 | — | — | 22 | 47 | 7 | — | 3 | 69 |
| Transitional cell carcinoma | D002295 | — | — | 15 | 36 | 14 | — | — | 57 |
| Serous cystadenocarcinoma | D018284 | — | — | 20 | 25 | 18 | — | — | 55 |
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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 | — | — | 36 | 25 | — | — | 4 | 50 |
| Lymphoma | D008223 | — | C85.9 | 25 | 12 | — | — | — | 32 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | 7 | 15 | — | — | 3 | 22 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 10 | 11 | — | — | 1 | 20 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 11 | 6 | — | — | — | 16 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 7 | 7 | — | — | — | 11 |
| Hemangiosarcoma | D006394 | — | — | 2 | 10 | — | — | — | 11 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 3 | 6 | — | — | 1 | 10 |
| Central nervous system neoplasms | D016543 | — | — | 5 | 6 | — | — | 1 | 10 |
| Neuroendocrine carcinoma | D018278 | — | — | 1 | 9 | — | — | — | 9 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | 7 | — | — | — | — | 7 |
| Hodgkin disease | D006689 | — | C81 | 4 | — | — | — | — | 4 |
| Neutropenia | D009503 | — | D70 | 1 | — | — | — | 3 | 4 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 2 | — | — | — | 1 | 3 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | — | — | — | 1 | 3 |
| Rectal neoplasms | D012004 | — | — | 2 | — | — | — | 1 | 3 |
| Fallopian tube diseases | D005184 | EFO_0009548 | N83 | 2 | — | — | — | 1 | 3 |
| Follicular lymphoma | D008224 | — | C82 | 3 | — | — | — | — | 3 |
| Intestinal neoplasms | D007414 | — | C26.0 | 3 | — | — | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | — | — | — | 2 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Popliteal artery entrapment syndrome | D000083082 | — | — | — | — | — | — | 5 | 5 |
| Drug-eluting stents | D054855 | — | — | — | — | — | — | 4 | 4 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 3 | 3 |
| Intracranial arteriosclerosis | D002537 | EFO_1000860 | I67.2 | — | — | — | — | 3 | 3 |
| Balloon angioplasty | D000800 | — | — | — | — | — | — | 3 | 3 |
| Biliary tract diseases | D001660 | EFO_0009534 | K83.9 | — | — | — | — | 3 | 3 |
| Taste disorders | D013651 | — | — | — | — | — | — | 2 | 2 |
| Dysgeusia | D004408 | — | R43.2 | — | — | — | — | 2 | 2 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | — | — | — | 2 | 2 |
| Vascular grafting | D058017 | — | — | — | — | — | — | 2 | 2 |
Show 69 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Paclitaxel |
| INN | paclitaxel |
| 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 class | antineoplastics, 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-ID | 33069-62-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL428647 |
| ChEBI ID | 45863 |
| PubChem CID | 36314 |
| DrugBank | DB01229 |
| UNII ID | P88XT4IS4D (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)
Variants
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Financial
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Abraxane – Bristol Myers Squibb
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Abraxane – Celgene
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 86,898 documents
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Safety
Black-box Warning
Black-box warning for: Abraxane, Paclitaxel, Paclitaxel injection,, Paclitaxel protein bound particles albumin bound, Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Adverse Events
Top Adverse Reactions
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95,748 adverse events reported
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