Docetaxel

Highest phase reached
Drug type
Small molecule
First approval year

First approval year
Listing at source
Listed
Highest phase reached

Drug type
Small molecule
Drug name
Docetaxel
Molecular weight
Structure (SMILES)
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]21)C3(C)C.O.O.O

  • beizray
  • Beizray
  • docetaxel
  • Docetaxel
  • docetaxel accord
  • Docetaxel accord
  • docetaxel teva
  • Docetaxel teva
  • Docetaxel zentiva (previously docetaxel winthrop)
  • docetaxel zentiva previously docetaxel winthrop
  • docivyx
  • Docivyx
  • taxceus
  • Taxceus
  • Taxespira (previously docetaxel hospira uk limited )
  • taxespira previously docetaxel hospira uk limited
  • taxotere
  • Taxotere

  • (2R,3S)-N-Carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5β,20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate
  • 2r 3s n carboxy 3 phenylisoserine n tert butyl ester 13 ester with 5β 20 epoxy 1 2α 4 7β 10β 13α hexahydroxytax 11 en 9 one 4 acetate 2 benzoate trihydrate
  • abt 348 and docetaxel
  • BH009 (Docetaxel injection)
  • docetaxel
  • Docetaxel
  • DOCETAXEL
  • Docetaxel (as trihydrate)
  • Docetaxel (DOC)
  • Docetaxel (post-operative)
  • docetaxel (T)
  • Docetaxel (T)
  • Docetaxel (Taxane)
  • Docetaxel (Taxotere)
  • docetaxel (Taxotere®)
  • Docetaxel (Taxotere®)
  • docetaxel (XRP6976)
  • Docetaxel (XRP6976)
  • DOCETAXEL (XRP6976)
  • DOCETAXEL [EMA EPAR]
  • DOCETAXEL [EP MONOGRAPH]
  • DOCETAXEL [ORANGE BOOK]
  • DOCETAXEL [USAN]
  • DOCETAXEL [USP IMPURITY]
  • DOCETAXEL [USP MONOGRAPH]

And 44 more, listed on the interactive page.

ATC classification codes
  • L01CD02
Sources for recorded values
ChEMBL ID
CHEMBL3545252
InChIKey
XCDIRYDKECHIPE-QHEQPUDQSA-N
PubChem compound IDs
  • 148123
RxNorm IDs (RxCUI)
  • 72962
FDA ingredient codes (UNII)
  • 15H5577CQD

  • 114977-28-5
  • 148408-66-6

Applicant
SANOFI AVENTIS US
Approval date
14 May 1996
Application number
NDA020449

Status
Authorised
Status date
27 Nov 1995
Authorisation date
27 Nov 1995
Approved indications
Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Product number
EMEA/H/C/000073
Authorisation holder
Sanofi Winthrop Industrie
Priority medicines scheme
No
Generic
No
Biosimilar
No
Generic medicines
2
Biosimilar medicines
0
Advanced therapy
No
Conditional approval
No
Additional monitoring
No
Accelerated assessment
No
Exceptional circumstances
No

Therapeutic areas

  • Adenocarcinoma
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Head and Neck Neoplasms
  • Prostatic Neoplasms
  • Stomach Neoplasms
European medicines record

Patents
8
Designations
2
Earliest recorded loss of exclusivity
16 May 2036
First in class
No
Fast track
No
Breakthrough designation
No
Orphan designation
No
Priority review
Yes
Orphan exclusivity
No
Accelerated approval
Yes
Availability
Prescription only
Boxed warning
Yes

Pharmacology name
docetaxel
Type
Synthetic organic
Drug name stem
-taxel
Approval recorded by Guide to Pharmacology
Yes

Administration routes

  • Parenteral

  • Action
    Inhibition
    Action type
    Inhibitor
    Target
    tubulin beta class I
    Gene symbol
    TUBB
    Protein identifier
    P07437
    Primary target
    Yes
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    P04350
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    P07437
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    P0DPH7
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    P68363
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    P68366
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    P68371
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q13509
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q13885
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q3ZCM7
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q6PEY2
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q71U36
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q9BQE3
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q9BUF5
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q9BVA1
  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin
    Protein identifier
    Q9H4B7

Open Targets mechanisms

  • Mechanism
    Tubulin inhibitor
    Action type
    Inhibitor
    Target
    Tubulin

  • Action type
    Inhibitor
    Gene symbol
    EGFR
    Protein identifier
    P00533
    Organism
    Homo sapiens
    Target development level
    Clinical
  • Action type
    Inhibitor
    Gene symbol
    TUBB|TUBB1|TUBB2A|TUBB2B|TUBB3|TUBB4A|TUBB4B|TUBB6|TUBB8
    Protein identifier
    P07437|Q9H4B7|Q13885|Q9BVA1|Q13509|P04350|P68371|Q9BUF5|Q3ZCM7
    Organism
    Homo sapiens
    Target development level
    Clinical

  • Condition
    Sarcoma, Ewing
    Highest recorded phase
    2
    Condition identifier
    EFO:0000174
    Subject identifier
    D012512
  • Condition
    Stomach Neoplasms
    Highest recorded phase
    4
    Condition identifier
    EFO:0000178
    Subject identifier
    D013274
  • Condition
    Carcinoma, Squamous Cell
    Highest recorded phase
    3
    Condition identifier
    EFO:0000181
    Subject identifier
    D002294
  • Condition
    Carcinoma, Hepatocellular
    Highest recorded phase
    2
    Condition identifier
    EFO:0000182
    Subject identifier
    D006528
  • Condition
    Prostatic Neoplasms
    Highest recorded phase
    4
    Condition identifier
    EFO:0000196
    Subject identifier
    D011471
  • Condition
    Myelodysplastic Syndromes
    Highest recorded phase
    1
    Condition identifier
    EFO:0000198
    Subject identifier
    D009190
  • Condition
    Squamous Cell Carcinoma of Head and Neck
    Highest recorded phase
    3
    Condition identifier
    EFO:0000199
    Subject identifier
    D000077195
  • Condition
    Neoplasms, Plasma Cell
    Highest recorded phase
    1
    Condition identifier
    EFO:0000200
    Subject identifier
    D054219
  • Condition
    Adenocarcinoma
    Highest recorded phase
    4
    Condition identifier
    EFO:0000228
    Subject identifier
    D000230
  • Condition
    Breast Neoplasms
    Highest recorded phase
    4
    Condition identifier
    EFO:0000305
    Subject identifier
    D001943
  • Condition
    Carcinoma
    Highest recorded phase
    3
    Condition identifier
    EFO:0000313
    Subject identifier
    D002277
  • Condition
    Carcinoma, Intraductal, Noninfiltrating
    Highest recorded phase
    2
    Condition identifier
    EFO:0000432
    Subject identifier
    D002285
  • Condition
    Carcinoma, Endometrioid
    Highest recorded phase
    1
    Condition identifier
    EFO:0000466
    Subject identifier
    D018269
  • Condition
    Stomach Neoplasms
    Highest recorded phase
    4
    Condition identifier
    EFO:0000503
    Subject identifier
    D013274
  • Condition
    Leiomyosarcoma
    Highest recorded phase
    2
    Condition identifier
    EFO:0000564
    Subject identifier
    D007890
  • Condition
    Leukemia
    Highest recorded phase
    2
    Condition identifier
    EFO:0000565
    Subject identifier
    D007938
  • Condition
    Adenocarcinoma of Lung
    Highest recorded phase
    3
    Condition identifier
    EFO:0000571
    Subject identifier
    D000077192
  • Condition
    Lymphoma
    Highest recorded phase
    1
    Condition identifier
    EFO:0000574
    Subject identifier
    D008223
  • Condition
    Neoplasms
    Highest recorded phase
    4
    Condition identifier
    EFO:0000616
    Subject identifier
    D009369
  • Condition
    Osteosarcoma
    Highest recorded phase
    2
    Condition identifier
    EFO:0000637
    Subject identifier
    D012516
  • Condition
    Prostatic Neoplasms
    Highest recorded phase
    4
    Condition identifier
    EFO:0000673
    Subject identifier
    D011471
  • Condition
    Carcinoma, Renal Cell
    Highest recorded phase
    1
    Condition identifier
    EFO:0000681
    Subject identifier
    D002292
  • Condition
    Sarcoma
    Highest recorded phase
    3
    Condition identifier
    EFO:0000691
    Subject identifier
    D012509
  • Condition
    Small Cell Lung Carcinoma
    Highest recorded phase
    2
    Condition identifier
    EFO:0000702
    Subject identifier
    D055752
  • Condition
    Carcinoma, Squamous Cell
    Highest recorded phase
    3
    Condition identifier
    EFO:0000707
    Subject identifier
    D002294

And 95 more, listed on the interactive page.

  • Condition identifier
    EFO_0000181
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000196
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000199
  • Condition identifier
    EFO_0000228
  • Condition identifier
    EFO_0000305
  • Condition identifier
    EFO_0000313
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000432
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000503
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000564
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000565
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000616
  • Condition identifier
    EFO_0000637
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000673
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000691
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000702
    Highest recorded phase
    2
  • Condition identifier
    EFO_0000707
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000708
  • Condition identifier
    EFO_0000756
    Highest recorded phase
    2
  • Condition identifier
    EFO_0001075
    Highest recorded phase
    2
  • Condition identifier
    EFO_0001376
  • Condition identifier
    EFO_0001416
    Highest recorded phase
    2
  • Condition identifier
    EFO_0001663
    Highest recorded phase
    2
  • Condition identifier
    EFO_0002618
  • Condition identifier
    EFO_0002916
    Highest recorded phase
    3
  • Condition identifier
    EFO_0002938
    Highest recorded phase
    3

And 268 more, listed on the interactive page.

  • Warning
    Black Box Warning
    Effect
    dermatological toxicity
  • Warning
    Black Box Warning
    Effect
    gastrointestinal toxicity
  • Warning
    Black Box Warning
    Effect
    hematological toxicity
  • Warning
    Black Box Warning
    Effect
    hepatotoxicity
  • Warning
    Black Box Warning
    Effect
    immune system toxicity
  • Warning
    Black Box Warning
    Effect
    respiratory toxicity
  • Warning
    Black Box Warning
    Effect
    vascular toxicity

  • Warning
    Black Box Warning
    Effect
    dermatological toxicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    gastrointestinal toxicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    hematological toxicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    hepatotoxicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    immune system toxicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    respiratory toxicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    vascular toxicity
    Country
    United States

  • Event
    alopecia
    Reports
    642
    Reporting signal score
    384.895
  • Event
    anaemia
    Reports
    2,990
    Reporting signal score
    1,620.56
  • Event
    bone marrow failure
    Reports
    778
    Reporting signal score
    806.103
  • Event
    dehydration
    Reports
    1,655
    Reporting signal score
    849.951
  • Event
    diarrhoea
    Reports
    4,761
    Reporting signal score
    1,375.61
  • Event
    disease progression
    Reports
    1,578
    Reporting signal score
    1,064.51
  • Event
    ejection fraction decreased
    Reports
    316
    Reporting signal score
    430.654
  • Event
    febrile neutropenia
    Reports
    2,863
    Reporting signal score
    3,948.54
  • Event
    flushing
    Reports
    1,152
    Reporting signal score
    752.625
  • Event
    leukopenia
    Reports
    1,467
    Reporting signal score
    1,336.2
  • Event
    malignant neoplasm progression
    Reports
    1,767
    Reporting signal score
    1,906.17
  • Event
    metastases to bone
    Reports
    589
    Reporting signal score
    876.407
  • Event
    metastases to liver
    Reports
    599
    Reporting signal score
    910.583
  • Event
    metastases to lung
    Reports
    210
    Reporting signal score
    354.841
  • Event
    metastases to lymph nodes
    Reports
    192
    Reporting signal score
    381.465
  • Event
    mucosal inflammation
    Reports
    1,257
    Reporting signal score
    1,693.18
  • Event
    myelosuppression
    Reports
    841
    Reporting signal score
    1,534.1
  • Event
    nausea
    Reports
    2,058
    Reporting signal score
    359.135
  • Event
    neuropathy peripheral
    Reports
    1,955
    Reporting signal score
    1,627.85
  • Event
    neutropenia
    Reports
    3,615
    Reporting signal score
    3,317.13
  • Event
    neutropenic sepsis
    Reports
    245
    Reporting signal score
    482.469
  • Event
    neutrophil count decreased
    Reports
    1,098
    Reporting signal score
    1,066.88
  • Event
    palmar-plantar erythrodysaesthesia syndrome
    Reports
    944
    Reporting signal score
    1,187.39
  • Event
    peripheral sensory neuropathy
    Reports
    508
    Reporting signal score
    884.881
  • Event
    pyrexia
    Reports
    2,995
    Reporting signal score
    805.212

And 2 more, listed on the interactive page.

And 1,424 more, listed on the interactive page.

Dose
75 mg/m2
Route
Intravenous
How often
Every 3 weeks

Hydrogen bond acceptors
14
Hydrogen bond donors
5
Polar surface area
224.45
Calculated partition coefficient (ALogP)
3.26
Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Rule-of-five violations
2
Rotatable bonds
8
Heavy atoms
61
Molecular formula
C43H59NO17
Monoisotopic mass
861.37829941
Natural product
No

  • 0143-9204
  • 0143-9205
  • 0409-0365
  • 0409-0366
  • 0409-0367
  • 0409-0368
  • 0409-4235
  • 0409-5068
  • 0955-1020
  • 0955-1021
  • 0955-1022
  • 23155-903
  • 23155-904
  • 23155-905
  • 43066-001
  • 43066-006
  • 43066-010
  • 43598-258
  • 43598-259
  • 43598-389
  • 43598-610
  • 43598-611
  • 45963-734
  • 45963-765
  • 66758-050

And 9 more, listed on the interactive page.

Recorded assays
1,468
Active assays
820

Active assay types

  • Confirmatory

These details could not be displayed.

Related records

Trials (2,292)

Approved for (21)

In development for (94)

Other linked conditions (2)

Targets (15)