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10 NDC API
23 Listed Suppliers
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69 Drugs in Development

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8 FDA Orange Book
11 Europe
3 Canada
12 Australia
3 South Africa
7 Listed Dossiers

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10 Annual Reports

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Synopsis

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FDF Dossiers

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2,414

Finished Drug Prices

159 RELATED EXCIPIENT COMPANIES

256EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1140909-48-3, Cabozantinib malate, Cabozantinib (s)-malate, Cabometyx, Cabozantinib malate (xl184), Xl184

Molecular Formula

C₃₂H₃₀FN₃O₁₀

Molecular Weight

635.6 g/mol

InChI Key

HFCFMRYTXDINDK-WNQIDUERSA-N

FDA UNII

DR7ST46X58

Cabozantinib S-malate is the s-malate salt form of cabozantinib, an orally bioavailable, small molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Cabozantinib strongly binds to and inhibits several RTKs, which are often overexpressed in a variety of cancer cell types, including hepatocyte growth factor receptor (MET), RET (rearranged during transfection), vascular endothelial growth factor receptor types 1 (VEGFR-1), 2 (VEGFR-2), and 3 (VEGFR-3), mast/stem cell growth factor (KIT), FMS-like tyrosine kinase 3 (FLT-3), TIE-2 (TEK tyrosine kinase, endothelial), tropomyosin-related kinase B (TRKB) and AXL. This may result in an inhibition of both tumor growth and angiogenesis, and eventually lead to tumor regression.

1 2D Structure

Cabozantinib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-N-[4-(6,7-dimethoxyquinolin-4-yl)oxyphenyl]-1-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide;(2S)-2-hydroxybutanedioic acid

2.1.2 InChI

InChI=1S/C28H24FN3O5.C4H6O5/c1-35-24-15-21-22(16-25(24)36-2)30-14-11-23(21)37-20-9-7-19(8-10-20)32-27(34)28(12-13-28)26(33)31-18-5-3-17(29)4-6-18;5-2(4(8)9)1-3(6)7/h3-11,14-16H,12-13H2,1-2H3,(H,31,33)(H,32,34);2,5H,1H2,(H,6,7)(H,8,9)/t;2-/m.0/s1

2.1.3 InChI Key

HFCFMRYTXDINDK-WNQIDUERSA-N

2.1.4 Canonical SMILES

COC1=CC2=C(C=CN=C2C=C1OC)OC3=CC=C(C=C3)NC(=O)C4(CC4)C(=O)NC5=CC=C(C=C5)F.C(C(C(=O)O)O)C(=O)O

2.1.5 Isomeric SMILES

COC1=CC2=C(C=CN=C2C=C1OC)OC3=CC=C(C=C3)NC(=O)C4(CC4)C(=O)NC5=CC=C(C=C5)F.C([C@@H](C(=O)O)O)C(=O)O

2.2 Other Identifiers

2.2.1 UNII

DR7ST46X58

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Bms 907351

2. Bms-907351

3. Bms907351

4. Cabozantinib

5. Cometriq

6. Xl 184

7. Xl-184

8. Xl184 Cpd

2.3.2 Depositor-Supplied Synonyms

1. 1140909-48-3

2. Cabozantinib Malate

3. Cabozantinib (s)-malate

4. Cabometyx

5. Cabozantinib Malate (xl184)

6. Xl184

7. Cabozantinib (s-malate)

8. Cometriq

9. Cabozantinib S-malate [usan]

10. Dr7st46x58

11. Bms907351

12. Chebi:72319

13. N-(4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)-n-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (s)-2-hydroxysuccinate

14. Cabometyx (tn)

15. Cometriq (tn)

16. Cabozantinib Malate (jan)

17. 1-n-[4-(6,7-dimethoxyquinolin-4-yl)oxyphenyl]-1-n'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide;(2s)-2-hydroxybutanedioic Acid

18. Cabozantinib S-malate (usan)

19. Cabozantinib Malate [jan]

20. Unii-dr7st46x58

21. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-(4-((6,7-dimethoxy-4-quinolinyl)oxy)phenyl)-n'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)

22. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)

23. Xl184 Malate

24. Cabozantinib L-malate

25. Bms907351 Malate

26. Xl184(cabozantinib Malate)

27. Mls006010951

28. Chembl2103868

29. Dtxsid60915949

30. Ex-a2819

31. Mfcd20923480

32. S4001

33. 1140909-48-3 (malate)

34. Akos025401945

35. Cabozantinib S-malate [who-dd]

36. Ccg-270301

37. Cs-0201

38. (2s)-2-hydroxybutanedioic Acid Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n'-(4-fluor

39. (2s)-2-hydroxybutanedioic Acid Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)

40. Ac-27471

41. As-75255

42. Hy-12044

43. Smr004702755

44. Cabozantinib S-malate [orange Book]

45. Sw218093-2

46. D10095

47. Q27139901

48. (2s)-2-hydroxybutanedioic Acid Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide

49. (2s)-2-hydroxybutanedioic Acid Compd. With N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)

50. (2s)-2-hydroxybutanedioic Acid; N'1-{4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl}-n1-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide

51. 1,1-cyclopropanedicarboxamide, N'-(4-((6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-n-(4- Fluorophenyl)- Mono((2s)-2-hydroxybutanedioate)

52. Cyclopropane-1,1-dicarboxylic Acid [4-(6,7-dimethoxy-quinoline-4-yloxy)-phenyl]-amide(4-fluoro-phenyl)-amide, (s) Malate Salt

53. N-(4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)-n'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide Mono((2s)-2-hydroxybutanedioate)

54. N-(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)-n-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (s)-2-hydroxysuccinate

55. N-{4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl}-n'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (2s)-2-hydroxybutanedioate

2.4 Create Date

2008-12-22

3 Chemical and Physical Properties

Molecular Formula	C₃₂H₃₀FN₃O₁₀
Molecular Weight	635.6 g/mol
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	12
Rotatable Bond Count	11
Exact Mass	635.19152232 g/mol
Monoisotopic Mass	635.19152232 g/mol
Topological Polar Surface Area	194 Å²
Heavy Atom Count	46
Formal Charge	0
Complexity	924
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Indication

* Renal Cell Carcinoma (RCC):

Cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):

- in treatment-nave adults with intermediate or poor risk,

- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.

Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.

* Hepatocellular Carcinoma (HCC):

Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.

5 Pharmacology and Biochemistry

5.1 ATC Code

L01EX07

API SUPPLIERS

01

Granules India Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Sichuan Elixir Pharmaceuticals

China

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LGM Pharma

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Fermion Oy

Finland

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05

Dr. Reddy's Laboratories

India

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Tagoor Laboratories

India

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Sichuan Elixir Pharmaceuticals

China

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Dr. Reddy's Laboratories

India

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Dr. Reddy's Laboratories

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Natco Pharma

India

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01

Sichuan Elixir Pharmaceutical Co Ltd

China

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Cabozantinib (s)-malate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39785

Submission : 2024-03-26

Status : Active

Type : II

02

Sichuan Elixir Pharmaceutical Co Ltd

China

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Cabozantinib Sulfate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39757

Submission : 2024-03-22

Status : Active

Type : II

03

Fermion Oy

Finland

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Cabozantinib S-malate

GDUFA

DMF Review : Complete

Rev. Date : 2020-04-17

Pay. Date : 2020-02-27

DMF Number : 34437

Submission : 2020-02-25

Status : Active

Type : II

04

Dr Reddys Laboratories Ltd

India

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Cabozantinib (s)-malate (form N-2)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39274

Submission : 2023-12-29

Status : Active

Type : II

05

Dr Reddys Laboratories Ltd

India

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Cabozantinib Intermediate (czt3)

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39141

Submission : 2023-12-01

Status : Active

Type : II

06

Dr Reddys Laboratories Ltd

India

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Cabozantinib Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38207

Submission : 2023-03-31

Status : Active

Type : II

07

Biocon Ltd

India

Antibody Engineering

Not Confirmed

08

Msn Laboratories Private Ltd

India

Antibody Engineering

Not Confirmed

09

Msn Laboratories Private Ltd

India

Antibody Engineering

Not Confirmed

10

Natco Pharma Ltd

India

Antibody Engineering

U.S.A

Antibody Engineering

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DOSAGE - CAPSULE;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 203756

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USFDA APPLICATION NUMBER - 203756

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Brand Name : Cometriq

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ABOUT THIS PAGE

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers

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2 EU WC

2 KDMF

10 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

69 Drugs in Development

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19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

44 FDF Dossiers

8 FDA Orange Book

11 Europe

3 Canada

12 Australia

3 South Africa

7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 20MG BASE

CAPSULE;ORAL - EQ 80MG BASE

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

8 DKSH

2 Faran Shimi Pharmaceutical

8 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

4 ACG Worldwide

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 BASF

10 Corel Pharma Chem

5 DFE Pharma

1 Finar

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

21 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Novo Excipients

2 Pharmatrans-Sanaq

2 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

14 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

46 Coating Systems & Additives

35 Fillers, Diluents & Binders

24 Disintegrants & Superdisintegrants

20 Controlled & Modified Release

19 Thickeners and Stabilizers

19 Direct Compression

15 Lubricants & Glidants

12 Film Formers & Plasticizers

12 Granulation

9 Co-Processed Excipients

9 Empty Capsules

5 Coloring Agents

5 Emulsifying Agents

4 Vegetarian Capsules

4 API Stability Enhancers

4 Taste Masking

4 Topical

3 Rheology Modifiers

3 Chewable & Orodispersible Aids