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Chemistry

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Also known as: 183133-96-2, Jevtana, Taxoid xrp6258, Txd 258, Xrp-6258, Cabazitaxelum
Molecular Formula
C45H57NO14
Molecular Weight
835.9  g/mol
InChI Key
BMQGVNUXMIRLCK-OAGWZNDDSA-N
FDA UNII
51F690397J

Cabazitaxel
Cabazitaxel is a semi-synthetic derivative of the natural taxoid 10-deacetylbaccatin III with potential antineoplastic activity. Cabazitaxel binds to and stabilizes tubulin, resulting in the inhibition of microtubule depolymerization and cell division, cell cycle arrest in the G2/M phase, and the inhibition of tumor cell proliferation. Unlike other taxane compounds, this agent is a poor substrate for the membrane-associated, multidrug resistance (MDR), P-glycoprotein (P-gp) efflux pump and may be useful for treating multidrug-resistant tumors. In addition, cabazitaxel penetrates the blood-brain barrier (BBB).
Cabazitaxel is a Microtubule Inhibitor. The physiologic effect of cabazitaxel is by means of Microtubule Inhibition.
1 2D Structure

Cabazitaxel

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-acetyloxy-1-hydroxy-15-[(2R,3S)-2-hydroxy-3-[(2-methylpropan-2-yl)oxycarbonylamino]-3-phenylpropanoyl]oxy-9,12-dimethoxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl] benzoate
2.1.2 InChI
InChI=1S/C45H57NO14/c1-24-28(57-39(51)33(48)32(26-17-13-11-14-18-26)46-40(52)60-41(3,4)5)22-45(53)37(58-38(50)27-19-15-12-16-20-27)35-43(8,36(49)34(55-10)31(24)42(45,6)7)29(54-9)21-30-44(35,23-56-30)59-25(2)47/h11-20,28-30,32-35,37,48,53H,21-23H2,1-10H3,(H,46,52)/t28-,29-,30+,32-,33+,34+,35-,37-,43+,44-,45+/m0/s1
2.1.3 InChI Key
BMQGVNUXMIRLCK-OAGWZNDDSA-N
2.1.4 Canonical SMILES
CC1=C2C(C(=O)C3(C(CC4C(C3C(C(C2(C)C)(CC1OC(=O)C(C(C5=CC=CC=C5)NC(=O)OC(C)(C)C)O)O)OC(=O)C6=CC=CC=C6)(CO4)OC(=O)C)OC)C)OC
2.1.5 Isomeric SMILES
CC1=C2[C@H](C(=O)[C@@]3([C@H](C[C@@H]4[C@]([C@H]3[C@@H]([C@@](C2(C)C)(C[C@@H]1OC(=O)[C@@H]([C@H](C5=CC=CC=C5)NC(=O)OC(C)(C)C)O)O)OC(=O)C6=CC=CC=C6)(CO4)OC(=O)C)OC)C)OC
2.2 Other Identifiers
2.2.1 UNII
51F690397J
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Jevtana

2. Kabazitaxel

2.3.2 Depositor-Supplied Synonyms

1. 183133-96-2

2. Jevtana

3. Taxoid Xrp6258

4. Txd 258

5. Xrp-6258

6. Cabazitaxelum

7. Xrp6258

8. Xrp 6258

9. Jevtana (tn)

10. Nsc-761432

11. Chebi:63584

12. Txd-258

13. 51f690397j

14. Kabazitaxel

15. Jevtana Kit

16. Cabazitaxel (jevtana)

17. (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-acetoxy-9-(((2r,3s)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1h-7,11-methanocyclodeca[3,4]benzo[1,2-b]oxet-12-yl Benzoate.

18. Cabazitaxel Acetonate

19. Cabazitaxel Acetonate [jan]

20. Cabazitaxel Injection

21. Cabazitaxel [usan:inn]

22. Jevanta

23. Txd258

24. Unii-51f690397j

25. Rpr 116258a

26. Rpr-116258a

27. Cabazitaxel [mi]

28. Cabazitaxel [inn]

29. Cabazitaxel (usan/inn)

30. Cabazitaxel [usan]

31. Cabazitaxel [vandf]

32. Cabazitaxel [mart.]

33. Cabazitaxel [who-dd]

34. Schembl179674

35. Cabazitaxel [ema Epar]

36. Gtpl6798

37. Chembl1201748

38. Amy4317

39. Cabazitaxel [orange Book]

40. Dtxsid40171389

41. Ex-a838

42. Mfcd18827611

43. Nsc761432

44. Nsc794609

45. S3022

46. Zinc85536932

47. Akos032947285

48. Ccg-270519

49. Cs-0972

50. Db06772

51. Nsc 761432

52. Nsc-794609

53. Ncgc00346704-01

54. Ncgc00346704-03

55. As-75355

56. Hy-15459

57. A25044

58. D09755

59. Ab01273971-01

60. Ab01273971_02

61. Q412963

62. Sr-01000941585

63. J-011721

64. J-519981

65. Sr-01000941585-1

66. (((tertbutoxy)carbonyl)amino)-2-hydroxy-3-phenylpropanoate1-hydroxy-7beta,10beta-dimethoxy-9-oxo-5beta,20-epoxytax-11-ene-2alpha,4,13alpha-triyl 4-acetate 2-benzoate 13-((2r,3s)-3-

67. (1s)-5beta,20-epoxy-9-oxo-7beta,10beta-dimethoxytaxa-11-ene-1,2alpha,4alpha,13alpha-tetraol 2-benzoate 4-acetate 13-[(2r,3s)-2-hydroxy-3-(tert-butoxycarbonylamino)-3-phenylpropionate]

68. (1s,2s,3r,4s,7r,9s,10s,12r,15s)-4-(acetyloxy)-15-{[(2r,3s)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1-hydroxy-9,12-dimethoxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0(3),(1)?.0?,?]heptadec-13-en-2-yl Benzoate

69. (1s,2s,3r,4s,7r,9s,10s,12r,15s)-4-(acetyloxy)-15-{[(2r,3s)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1-hydroxy-9,12-dimethoxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0^{3,10}.0^{4,7}]heptadec-13-en-2-yl Benzoate

70. (2alpha,5beta,7beta,10beta,13alpha)-4-acetoxy-13-({(2r,3s)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl Benzoate

71. (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-acetoxy-9-(((2r,3s)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-11-hydroxy-4,6-dimethoxy-4a,8,13,1

72. (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-acetoxy-9-(((2r,3s)-3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1h-7,11-methanocyclodeca[3,4]benzo[1,2-b]oxet-12-yl Benzoate

73. [(1s,2s,3r,4s,7r,9s,10s,12r,15s)-4-acetyloxy-1-hydroxy-15-[(2r,3s)-2-hydroxy-3-[(2-methylpropan-2-yl)oxycarbonylamino]-3-phenylpropanoyl]oxy-9,12-dimethoxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.03,10.04,7]heptadec-13-en-2-yl] Benzoate

74. 1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-ene-2,4,13-triyl 4-acetate 2-benzoate 13-((2r,3s)-3-(((tertbutoxy)carbonyl)amino)-2-hydroxy-3-phenylpropanoate)

75. 1-hydroxy-7.beta.,10.beta.-dimethoxy-9-oxo-5.beta.,20-epoxytax-11-ene-2.alpha.,4,13.alpha.-triyl 4-acetate 2-benzoate 13-((2r,3s)-3-(((tert-butoxy)carbonyl)amino)-2-hydroxy-3-phenylpropanoate)

76. Benzenepropanoic Acid, Beta-[[(1,1-dimethylethoxy)carbonyl]amino]-alpha-hydroxy-, (2ar,4s,4as,6r,9s,11s,12s,12ar,12bs)-12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1h-cyclodeca[3,4]benz[1,2-b]oxet-9-yl Ester, (alphar,betas)-

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 835.9 g/mol
Molecular Formula C45H57NO14
XLogP32.7
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count14
Rotatable Bond Count15
Exact Mass835.37790549 g/mol
Monoisotopic Mass835.37790549 g/mol
Topological Polar Surface Area202 Ų
Heavy Atom Count60
Formal Charge0
Complexity1690
Isotope Atom Count0
Defined Atom Stereocenter Count11
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameJevtana kit
Active IngredientCabazitaxel
Dosage FormSolution
RouteIv (infusion)
Strength60mg/1.5ml (40mg/ml)
Market StatusPrescription
CompanySanofi Aventis Us

2 of 2  
Drug NameJevtana kit
Active IngredientCabazitaxel
Dosage FormSolution
RouteIv (infusion)
Strength60mg/1.5ml (40mg/ml)
Market StatusPrescription
CompanySanofi Aventis Us

4.2 Drug Indication

For treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.


FDA Label


Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.


Treatment of prostate cancer


Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Cabaitaxel has anti-tumour properties and is effective against docetaxel-sensitive and -insensitive tumours.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
CABAZITAXEL
5.2.2 FDA UNII
51F690397J
5.2.3 Pharmacological Classes
Established Pharmacologic Class [EPC] - Microtubule Inhibitor
5.3 ATC Code

L01CD


L01CD04


L01CD04


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01C - Plant alkaloids and other natural products

L01CD - Taxanes

L01CD04 - Cabazitaxel


5.4 Absorption, Distribution and Excretion

Absorption

After an intravenous dose of cabazitaxel 25 mg/m2 every three weeks to a population of 170 patients with solid tumors, the mean Cmax in patients with metastatic prostate cancer was 226 ng/mL (CV 107%) and was reached at the end of the one-hour infusion (Tmax). The mean AUC in patients with metastatic prostate cancer was 991 ng.h/mL (CV 34%). Administration with prednisone or prednisolone do not effect the pharmacokinetic profile of cabazitaxel.


Route of Elimination

After a one-hour intravenous infusion [14C]-cabazitaxel 25 mg/m2, approximately 80% of the administered dose was eliminated within 2 weeks. Cabazitaxel is mainly excreted in the feces as numerous metabolites (76% of the dose); while renal excretion of cabazitaxel and metabolites account for 3.7% of the dose (2.3% as unchanged drug in urine).


Volume of Distribution

The volume of distribution (Vss) was 4,864 L (2,643 L/m2 for a patient with a median BSA of 1.84 m2) at steady state. Compared to other taxanes, penetrates the CNS to a greater extent.


Clearance

Cabazitaxel has a plasma clearance of 48.5 L/h (CV 39%; 26.4 L/h/m2 for a patient with a median BSA of 1.84 m2) in patients with metastatic prostate cancer.


5.5 Metabolism/Metabolites

Cabazitaxel is extensively metabolized in the liver (>95%), mainly by the CYP3A4/5 isoenzyme (80% to 90%), and to a lesser extent by CYP2C8 which results in 20 different metabolites. Two of these metabolites are active demethylated derivatives of cabaxitaxel and referred to as RPR112698 and RPR123142 respectively. Docetaxel is another metabolite of cabazitaxel. Cabazitaxel is the main circulating moiety in human plasma.


5.6 Biological Half-Life

Following a one-hour intravenous infusion, plasma concentrations of cabazitaxel can be described by a three-compartment pharmacokinetic model with -, -, and - half-lives of 4 minutes, 2 hours, and 95 hours, respectively.


5.7 Mechanism of Action

Cabazitaxel is a microtubule inhibitor. Cabazitaxel binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the interference of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell.


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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766428200,"product":"CABAZITAXEL","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HETERO LABS LTD","supplierCountry":"INDIA","foreign_port":"APIIC MAHABOOBNAGAR","customer":"HETERO LABS LTD SEZ UNIT II","customerCountry":"INDIA","quantity":"0.84","actualQuantity":"0.84","unit":"KGS","unitRateFc":"55924.5","totalValueFC":"46741.2","currency":"USD","unitRateINR":5008036.8452380961,"date":"23-Dec-2025","totalValueINR":"4206750.95","totalValueInUsd":"46741.2","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29329990","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEZ\/Mahaboobnagar","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671561000,"product":"CABAZITAXEL (QTY- 800 GRAMS )","address":"PLOT NO.2, MAITHRIVIHAR AMEERPET,","city":"HYDERABAD","supplier":"SICHUAN XIELI PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"EUGIA PHARMA SPECIALITIES LTD","customerCountry":"INDIA","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"183000","totalValueFC":"148431.9","currency":"USD","unitRateINR":"15289650","date":"21-Dec-2022","totalValueINR":"12231720","totalValueInUsd":"148431.9","indian_port":"HYDERABAD AIR","hs_no":"29329990","bill_no":"3842085","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITHRIVIHAR AMEERPET,"}]
29-Mar-2022
23-Dec-2025
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Drugs in Development

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Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Neoplasms.


Lead Product(s): Cabazitaxel,Prednisone

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Cytotoxic Drug

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 30, 2015

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Lead Product(s) : Cabazitaxel,Prednisone

Therapeutic Area : Oncology

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Neoplasms.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

June 30, 2015

Sanofi Company Banner

Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Neoplasms.


Lead Product(s): Cabazitaxel,Pegfilgrastim,Prednisolone,Dexchloropheniramine Maleate,Diphenhydramine,Ranitidine,Metoclopramide,Granisetron,

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Cytotoxic Drug

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 12, 2015

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02

Sanofi

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Lead Product(s) : Cabazitaxel, Pegfilgrastim, Prednisolone, Dexchloropheniramine Maleate, Diphenhydramine

Therapeutic Area : Oncology

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Neoplasms.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

May 12, 2015

Sanofi Company Banner

Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Prostatic Neoplasms.


Lead Product(s): Cabazitaxel,Prednisone

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Cytotoxic Drug

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 04, 2015

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Sanofi

France
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Lead Product(s) : Cabazitaxel,Prednisone

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Prostatic Neoplasms.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

March 04, 2015

Sanofi Company Banner

Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Carcinoma, Transitional Cell.


Lead Product(s): Cabazitaxel,Gemcitabine

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Cytotoxic Drug

Sponsor: Guarionex J. Decastro

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 29, 2014

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Sanofi

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Lead Product(s) : Cabazitaxel,Gemcitabine

Therapeutic Area : Oncology

Highest Development Status : Phase I/ Phase II

Partner/Sponsor/Collaborator : Guarionex J. Decastro

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Carcinoma, Transitional Cell.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

July 29, 2014

Sanofi Company Banner

Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Nonseminomatous germ cell tumor.


Lead Product(s): Cabazitaxel,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Cytotoxic Drug

Sponsor: Gustave Roussy

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 15, 2014

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Sanofi

France
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Lead Product(s) : Cabazitaxel,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Gustave Roussy

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Nonseminomatous germ cell tumor.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

April 15, 2014

Sanofi Company Banner

Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Neoplasms.


Lead Product(s): Cabazitaxel,Prednisone,Prednisolone

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Cytotoxic Drug

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 28, 2014

Sanofi Company Banner

06

Sanofi

France
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Lead Product(s) : Cabazitaxel,Prednisone,Prednisolone

Therapeutic Area : Oncology

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Prostatic Neoplasms.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

February 28, 2014

Sanofi Company Banner

Details:

Taxotere is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Prostatic Neoplasms, Castration-Resistant.


Lead Product(s): Docetaxel,Cabazitaxel

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Cytotoxic Drug

Sponsor: Gustave Roussy

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 24, 2014

Sanofi Company Banner

07

Sanofi

France
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Lead Product(s) : Docetaxel,Cabazitaxel

Therapeutic Area : Oncology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Gustave Roussy

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Taxotere is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Prostatic Neoplasms, Castration-Resistant.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

January 24, 2014

Sanofi Company Banner

Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.


Lead Product(s): Cabazitaxel,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Cytotoxic Drug

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 24, 2012

Sanofi Company Banner

08

Sanofi

France
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Lead Product(s) : Cabazitaxel,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Neoplasms.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

December 24, 2012

Sanofi Company Banner

Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Nervous System Neoplasms.


Lead Product(s): Cabazitaxel,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Cytotoxic Drug

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 17, 2012

Sanofi Company Banner

09

Sanofi

France
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Lead Product(s) : Cabazitaxel,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase I/ Phase II

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Nervous System Neoplasms.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

December 17, 2012

Sanofi Company Banner

Details:

Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Carcinoma, Transitional Cell.


Lead Product(s): Cabazitaxel,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase II/ Phase IIIProduct Type: Cytotoxic Drug

Sponsor: Anjali Zarkar

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 20, 2012

Sanofi Company Banner

10

Sanofi

France
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Lead Product(s) : Cabazitaxel,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase II/ Phase III

Partner/Sponsor/Collaborator : Anjali Zarkar

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Cabazitaxel is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Carcinoma, Transitional Cell.

Product Name : Undisclosed

Product Type : Cytotoxic Drug

Upfront Cash : Inapplicable

August 20, 2012

Sanofi Company Banner
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FDF Dossiers

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  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Regulatory Info : RX

Registration Country : USA

CABAZITAXEL

Brand Name : JEVTANA KIT

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 60MG/1.5ML (40MG/ML)

Packaging :

Approval Date : 2010-06-17

Application Number : 201023

Regulatory Info : RX

Registration Country : USA

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Regulatory Info :

Registration Country : Italy

Cabazitaxel

Brand Name : Jevtana

Dosage Form : Cabazitaxel 60Mg 1 Unit Parenteral Use

Dosage Strength : 1 vial EV 60 mg 1.5 ml + 1 vial solv 4.5 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Regulatory Info : Allowed

Registration Country : Switzerland

Cabazitaxelum

Brand Name : Jevtana

Dosage Form : Solution For Injection

Dosage Strength : 60mg/1.5ml

Packaging :

Approval Date : 06/04/2011

Application Number : 61543

Regulatory Info : Allowed

Registration Country : Switzerland

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Regulatory Info : Authorized

Registration Country : Spain

Water For Injectable Preparations; Cabazitaxel

Brand Name : Jevtana

Dosage Form : Concentrate And Solvent For Infusion Solution

Dosage Strength : 60MG

Packaging :

Approval Date : 07-04-2011

Application Number : 11676001

Regulatory Info : Authorized

Registration Country : Spain

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Regulatory Info : Authorized

Registration Country : Spain

Cabazitaxel

Brand Name : Jevtana

Dosage Form : Concentrate And Solvent For Infusion Solution

Dosage Strength : 60MG

Packaging :

Approval Date : 28-11-2019

Application Number : 11676001IP

Regulatory Info : Authorized

Registration Country : Spain

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Regulatory Info : Prescription

Registration Country : Denmark

Cabazitaxel

Brand Name : Jevtana

Dosage Form : Infusion Solution

Dosage Strength : 60mg/1.5ml

Packaging :

Approval Date : 17-03-2011

Application Number : 28104713710

Regulatory Info : Prescription

Registration Country : Denmark

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Regulatory Info : Approved

Registration Country : Sweden

Cabazitaxel

Brand Name : Jevtana

Dosage Form : Infusion Solution

Dosage Strength : 60mg

Packaging :

Approval Date : 17-03-2011

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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Regulatory Info : Originator

Registration Country : South Africa

Cabazitaxel

Brand Name : Jevtana

Dosage Form : INF

Dosage Strength : 60mg/6ml

Packaging : 6X1mg/6ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Regulatory Info : RX

Registration Country : USA

CABAZITAXEL

Brand Name : CABAZITAXEL

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 60MG/1.5ML (40MG/ML)

Packaging :

Approval Date : 2023-02-10

Application Number : 207718

Regulatory Info : RX

Registration Country : USA

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Regulatory Info :

Registration Country : India

Cabazitaxel

Brand Name : Cabazitaxel

Dosage Form : Injectable

Dosage Strength : 40 mg/ml (1.5 ml)

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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ABOUT THIS PAGE

Looking for 183133-96-2 / Cabazitaxel API manufacturers, exporters & distributors?

Cabazitaxel manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cabazitaxel API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cabazitaxel manufacturer or Cabazitaxel supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cabazitaxel manufacturer or Cabazitaxel supplier.

PharmaCompass also assists you with knowing the Cabazitaxel API Price utilized in the formulation of products. Cabazitaxel API Price is not always fixed or binding as the Cabazitaxel Price is obtained through a variety of data sources. The Cabazitaxel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cabazitaxel

Synonyms

183133-96-2, Jevtana, Taxoid xrp6258, Txd 258, Xrp-6258, Cabazitaxelum

Cas Number

183133-96-2

Unique Ingredient Identifier (UNII)

51F690397J

About Cabazitaxel

Cabazitaxel is a semi-synthetic derivative of the natural taxoid 10-deacetylbaccatin III with potential antineoplastic activity. Cabazitaxel binds to and stabilizes tubulin, resulting in the inhibition of microtubule depolymerization and cell division, cell cycle arrest in the G2/M phase, and the inhibition of tumor cell proliferation. Unlike other taxane compounds, this agent is a poor substrate for the membrane-associated, multidrug resistance (MDR), P-glycoprotein (P-gp) efflux pump and may be useful for treating multidrug-resistant tumors. In addition, cabazitaxel penetrates the blood-brain barrier (BBB).

TXD258 Manufacturers

A TXD258 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TXD258, including repackagers and relabelers. The FDA regulates TXD258 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TXD258 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of TXD258 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

TXD258 Suppliers

A TXD258 supplier is an individual or a company that provides TXD258 active pharmaceutical ingredient (API) or TXD258 finished formulations upon request. The TXD258 suppliers may include TXD258 API manufacturers, exporters, distributors and traders.

click here to find a list of TXD258 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

TXD258 USDMF

A TXD258 DMF (Drug Master File) is a document detailing the whole manufacturing process of TXD258 active pharmaceutical ingredient (API) in detail. Different forms of TXD258 DMFs exist exist since differing nations have different regulations, such as TXD258 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A TXD258 DMF submitted to regulatory agencies in the US is known as a USDMF. TXD258 USDMF includes data on TXD258's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TXD258 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of TXD258 suppliers with USDMF on PharmaCompass.

TXD258 WC

A TXD258 written confirmation (TXD258 WC) is an official document issued by a regulatory agency to a TXD258 manufacturer, verifying that the manufacturing facility of a TXD258 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TXD258 APIs or TXD258 finished pharmaceutical products to another nation, regulatory agencies frequently require a TXD258 WC (written confirmation) as part of the regulatory process.

click here to find a list of TXD258 suppliers with Written Confirmation (WC) on PharmaCompass.

TXD258 NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing TXD258 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for TXD258 API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture TXD258 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain TXD258 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TXD258 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of TXD258 suppliers with NDC on PharmaCompass.

TXD258 GMP

TXD258 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of TXD258 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right TXD258 GMP manufacturer or TXD258 GMP API supplier for your needs.

TXD258 CoA

A TXD258 CoA (Certificate of Analysis) is a formal document that attests to TXD258's compliance with TXD258 specifications and serves as a tool for batch-level quality control.

TXD258 CoA mostly includes findings from lab analyses of a specific batch. For each TXD258 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

TXD258 may be tested according to a variety of international standards, such as European Pharmacopoeia (TXD258 EP), TXD258 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TXD258 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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