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Chemistry

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Also known as: 319460-85-0, Ag-013736, Inlyta, Ag 013736, (e)-n-methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1h-indazol-6-yl)thio)benzamide, Ag-13736
Molecular Formula
C22H18N4OS
Molecular Weight
386.5  g/mol
InChI Key
RITAVMQDGBJQJZ-FMIVXFBMSA-N
FDA UNII
C9LVQ0YUXG

Axitinib
A benzamide and indazole derivative that acts as a TYROSINE KINASE inhibitor of the VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR. It is used in the treatment of advanced RENAL CELL CARCINOMA.
Axitinib is a Kinase Inhibitor. The mechanism of action of axitinib is as a Receptor Tyrosine Kinase Inhibitor.
1 2D Structure

Axitinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-methyl-2-[[3-[(E)-2-pyridin-2-ylethenyl]-1H-indazol-6-yl]sulfanyl]benzamide
2.1.2 InChI
InChI=1S/C22H18N4OS/c1-23-22(27)18-7-2-3-8-21(18)28-16-10-11-17-19(25-26-20(17)14-16)12-9-15-6-4-5-13-24-15/h2-14H,1H3,(H,23,27)(H,25,26)/b12-9+
2.1.3 InChI Key
RITAVMQDGBJQJZ-FMIVXFBMSA-N
2.1.4 Canonical SMILES
CNC(=O)C1=CC=CC=C1SC2=CC3=C(C=C2)C(=NN3)C=CC4=CC=CC=N4
2.1.5 Isomeric SMILES
CNC(=O)C1=CC=CC=C1SC2=CC3=C(C=C2)C(=NN3)/C=C/C4=CC=CC=N4
2.2 Other Identifiers
2.2.1 UNII
C9LVQ0YUXG
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ag 013736

2. Ag-013736

3. Ag013736

4. Inlyta

2.3.2 Depositor-Supplied Synonyms

1. 319460-85-0

2. Ag-013736

3. Inlyta

4. Ag 013736

5. (e)-n-methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1h-indazol-6-yl)thio)benzamide

6. Ag-13736

7. Ag013736

8. C9lvq0yuxg

9. N-methyl-2-((3-((1e)-2-(pyridin-2-yl)ethenyl)-1h-indazol-6-yl)sulfanyl)benzamide

10. Nsc-757441

11. Chebi:66910

12. (e)-n-methyl-2-(3-(2-(pyridin-2-yl)vinyl)-1h-indazol-6-ylthio)benzamide

13. N-methyl-2-[[3-[(e)-2-pyridin-2-ylethenyl]-1h-indazol-6-yl]sulfanyl]benzamide

14. Nsc757441

15. N-methyl-2-({3-[(e)-2-(pyridin-2-yl)ethenyl]-1h-indazol-6-yl}sulfanyl)benzamide

16. Ncgc00241108-01

17. S1005

18. Dsstox_cid_28975

19. Dsstox_rid_83240

20. Dsstox_gsid_49049

21. Axitinib (ag 013736)

22. N-methyl-2-({3-[(e)-2-(pyridin-2-yl)vinyl]-1h-indazol-6-yl}sulfanyl)benzamide

23. N-methyl-2-(3-((e)-2-pyridin-2-yl-vinyl)-1h-indazol-6-ylsulfanyl)-benzamide

24. Axitinib [usan]

25. Cas-319460-85-0

26. Unii-c9lvq0yuxg

27. Axitinibum

28. Axitinib [usan:inn:jan]

29. 4agc

30. Benzamide, N-methyl-2-((3-((1e)-2-(2-pyridinyl)ethenyl)-1h-indazol-6-yl)thio)-

31. Benzamide, N-methyl-2-[[3-[(1e)-2-(2-pyridinyl)ethenyl]-1h-indazol-6-yl]thio]-

32. Inlyta (tn)

33. Mfcd09837898

34. Ag13736

35. 4ag8

36. Axitinib (jan/usan)

37. Axitinib [inn]

38. Axitinib [jan]

39. Axitinib [mi]

40. Axitinib [vandf]

41. Axitinib [mart.]

42. Ag-013736;axitinib

43. Axitinib [who-dd]

44. Axitinib,ag-013736

45. Mls006010164

46. Schembl172918

47. Axitinib [orange Book]

48. Gtpl5659

49. Axitinib, >=98% (hplc)

50. Chembl1289926

51. Dtxsid3049049

52. N-methyl-2-[[3-[2-(2-pyridinyl)ethenyl]-1h-indazol-6-yl]thio]benzamide

53. Schembl22930506

54. Bdbm25117

55. Chebi:94568

56. Ex-a337

57. Bcpp000372

58. Bcp01371

59. Zinc3816287

60. Tox21_113597

61. Nsc799341

62. Akos015902898

63. Tox21_113597_1

64. Ac-1539

65. Bcp9000345

66. Ccg-264772

67. Cs-0116

68. Db06626

69. Ks-1448

70. Nsc 757441

71. Nsc-799341

72. Benzamide, N-methyl-2-((3-((e)-2-(2-pyridinyl)ethenyl)-1h-indazol-6-yl)thio)-

73. Ncgc00241108-04

74. Ncgc00241108-06

75. Hy-10065

76. Smr002530046

77. Am20090673

78. Sw219464-1

79. D03218

80. Ab01274739-01

81. Ab01274739_02

82. 460a850

83. Sr-01000941566

84. J-502064

85. Q-200662

86. Q4830631

87. Sr-01000941566-1

88. Brd-k29905972-001-01-4

89. Brd-k29905972-001-02-2

90. Benzamide, N-methyl-2-((3-((1e)-2-(2-pyridinyl)ethenyl)-1h-indazo)-6-yl)thio)-

91. N-methyl-[[3[(1e)-2-(2-pyridinyl)ethenyl]-1h-indazol-6-yl]thio]-benzamide

92. N-methyl-2((3-((1e0-2-(pyridin-2-yl)ethenyl)-1h-inazol-6-ylsufanyl)benzamide

93. N-methyl-2-({3-[(e)-2-pyridin-2-ylethenyl]-2h-indazol-6-yl}sulfanyl)benzamide

2.4 Create Date
2006-04-29
3 Chemical and Physical Properties
Molecular Weight 386.5 g/mol
Molecular Formula C22H18N4OS
XLogP34.2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass386.12013238 g/mol
Monoisotopic Mass386.12013238 g/mol
Topological Polar Surface Area96 Ų
Heavy Atom Count28
Formal Charge0
Complexity557
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameInlyta
PubMed HealthAxitinib (By mouth)
Drug ClassesAntineoplastic Agent
Drug LabelINLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structur...
Active IngredientAxitinib
Dosage FormTablet
RouteOral
Strength1mg; 5mg
Market StatusPrescription
CompanyPfizer

2 of 2  
Drug NameInlyta
PubMed HealthAxitinib (By mouth)
Drug ClassesAntineoplastic Agent
Drug LabelINLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structur...
Active IngredientAxitinib
Dosage FormTablet
RouteOral
Strength1mg; 5mg
Market StatusPrescription
CompanyPfizer

4.2 Drug Indication

Used in kidney cell cancer and investigated for use/treatment in pancreatic and thyroid cancer.


FDA Label


Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Axitinib prevents the progression of cancer by inhibiting angiogenesis and blocking tumor growth.


5.2 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)


Protein Kinase Inhibitors

Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
AXITINIB
5.3.2 FDA UNII
C9LVQ0YUXG
5.3.3 Pharmacological Classes
Receptor Tyrosine Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
5.4 ATC Code

L01EK01


L01XE17

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EK - Vascular endothelial growth factor receptor (vegfr) tyrosine kinase inhibitors

L01EK01 - Axitinib


5.5 Absorption, Distribution and Excretion

Absorption

After one 5 mg dose of axitinib, it takes about 2.5 to 4.1 hours to reach maximum plasma concentration.


Route of Elimination

Axitinib is mainly eliminated unchanged in the feces (41%) with 12% of the original dose as unchanged axitinib. There is also 23% eliminated in the urine, most of which are metabolites.


Volume of Distribution

The volume of distribution is 160 L.


Clearance

The average clearance of axitinib is 38 L/h.


5.6 Metabolism/Metabolites

Axitinib undergoes mainly hepatic metabolism. CYP3A4 and CYP3A5 are the main hepatic enzymes while CYP1A2, CYP2C19, and UGT1A1 enzymes are secondary.


5.7 Biological Half-Life

Axitinib has a half life of 2.5 to 6.1 hours.


5.8 Mechanism of Action

Axitinib selectively blocks the tyrosine kinase receptors VEGFR-1 (vascular endothelial growth factor receptor), VEGFR-2, and VEGFR-3.


USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2015-12-18

Pay. Date : 2015-09-23

DMF Number : 29672

Submission : 2015-09-29

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2023-06-27

Pay. Date : 2023-02-06

DMF Number : 37971

Submission : 2023-02-02

Status : Active

Type : II

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39323

Submission : 2023-12-27

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2016-04-15

Pay. Date : 2015-10-29

DMF Number : 29918

Submission : 2015-10-10

Status : Active

Type : II

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Axitinib OH)

Date of Issue : 2022-06-17

Valid Till : 2025-07-02

Written Confirmation Number : WC-0082

Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...

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Hetero Drugs

India
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India
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Axitinib IH

Date of Issue : 2022-09-16

Valid Till : 2025-08-08

Written Confirmation Number : WC-0041

Address of the Firm : Unit-I, Survey No.10, I.D.A, Gaddapotharam Village, Jinnaram Mandal,Medak Dist, ...

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Hetero Drugs

India
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Axitinib IH

Date of Issue : 2019-09-03

Valid Till : 2022-08-08

Written Confirmation Number : WC-0041A3

Address of the Firm : Unit-I, Survey No.10, I.D.A, Gaddapotharam Village, Jinnaram Mandal,Medak Dist, ...

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Axitinib IHS

Date of Issue : 2022-09-02

Valid Till : 2025-05-05

Written Confirmation Number : WC-0349

Address of the Firm : MIs. MSN Laboratories Private Limited, Unit-II, sv. No, 50, Kardanur (Village), ...

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Axitinib IH

Date of Issue : 2021-06-11

Valid Till : 2022-07-02

Written Confirmation Number : WC-0147A3

Address of the Firm : 100% EOU, Raichur Industrial Growth Centre, Plot No. 33, 33A, 40-47, Chicksugur-...

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AXITINIB

NDC Package Code : 54893-0043

Start Marketing Date : 2016-02-01

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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AXITINIB

NDC Package Code : 54893-0032

Start Marketing Date : 2014-12-23

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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NDC Package Code : 82920-028

Start Marketing Date : 2022-08-15

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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AXITINIB

NDC Package Code : 65344-0033

Start Marketing Date : 2023-12-29

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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LGM Pharma

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Axitinib

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About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

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About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission i...

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About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...

Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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Axitinib

About the Company : Morepen Laboratories Ltd.’ is 31 years old company. Went to public in 1993. Manufacturer and Exporter of complex and high margins molecules (APIs/Intermediates) for regulated mar...

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About the Company : Shenzhen HwaGen Pharmaceutical Co., Ltd. (HwaGen Pharma) was founded in December of 2015 under the leadership of a “National 1000 Talents Program” expert. By leveraging its cor...

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26-Feb-2021
19-Apr-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
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Drugs in Development

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Details:

Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant with axitinib, small molecule TKI with anti-angiogenic properties. It is being developed for the treatment of wet AMD.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 15, 2024

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01

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant with axitinib, small molecule TKI with anti-angiogenic properties. It is being developed for the treatment of wet AMD.

Brand Name : Axpaxli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 15, 2024

blank

Details:

CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: CLS-AX

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 09, 2024

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02

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.

Brand Name : CLS-AX

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 09, 2024

blank

Details:

CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: CLS-AX

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 27, 2024

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03

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.

Brand Name : CLS-AX

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 27, 2024

blank

Details:

Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant with axitinib, small molecule TKI with anti-angiogenic properties. It is being developed for the treatment of wet AMD.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 07, 2024

blank

04

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant with axitinib, small molecule TKI with anti-angiogenic properties. It is being developed for the treatment of wet AMD.

Brand Name : Axpaxli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 07, 2024

blank

Details:

Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor for the treatment of WET AMD.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 30, 2024

blank

05

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor for the treatment of WET AMD.

Brand Name : Axpaxli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 30, 2024

blank

Details:

Axpaxli (axitinib) is a bioresorbable hydrogel implant incorporating axitinib, a multi-target tyrosine kinase inhibitor, being developed for diabetic retinopathy treatment.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 18, 2024

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06

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Axpaxli (axitinib) is a bioresorbable hydrogel implant incorporating axitinib, a multi-target tyrosine kinase inhibitor, being developed for diabetic retinopathy treatment.

Brand Name : Axpaxli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 18, 2024

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Details:

JS001 (toripalimab) is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions. It is approved in combination with axitinib for the treatment of renal carcinoma.


Lead Product(s): Toripalimab,Axitinib

Therapeutic Area: Oncology Brand Name: Tuoyi

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 07, 2024

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07

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : JS001 (toripalimab) is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions. It is approved in combination with axitinib for the treatment of renal carcinoma.

Brand Name : Tuoyi

Molecule Type : Large molecule

Upfront Cash : Not Applicable

April 07, 2024

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Details:

The company intends to use the net proceeds from the private placement to accelerate the clinical development of Axpali (axitinib) for the treatment of wet age-related macular degeneration.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Venrock Healthcare Capital Partners

Deal Size: $325.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement February 22, 2024

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08

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Lead Product(s) : Axitinib

Therapeutic Area : Ophthalmology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Venrock Healthcare Capital Partners

Deal Size : $325.0 million

Deal Type : Private Placement

Details : The company intends to use the net proceeds from the private placement to accelerate the clinical development of Axpali (axitinib) for the treatment of wet age-related macular degeneration.

Brand Name : Axpaxli

Molecule Type : Small molecule

Upfront Cash : Undisclosed

February 22, 2024

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Details:

Axpaxli (axitinib) is a bioresorbable hydrogel implant incorporating axitinib, developed for wet age-related macular degeneration treatment.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 13, 2024

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09

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Axpaxli (axitinib) is a bioresorbable hydrogel implant incorporating axitinib, developed for wet age-related macular degeneration treatment.

Brand Name : Axpaxli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 13, 2024

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Details:

Axpaxli (axitinib) is an investigational hydrogel implant containing axitinib, being evaluated in phase 3 trials for treating wet AMD and other retinal diseases.


Lead Product(s): Axitinib

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 25, 2024

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10

CPHI Middle east
Not Confirmed
CPHI Middle east
Not Confirmed

Details : Axpaxli (axitinib) is an investigational hydrogel implant containing axitinib, being evaluated in phase 3 trials for treating wet AMD and other retinal diseases.

Brand Name : Axpaxli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 25, 2024

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INTERMEDIATES SUPPLIERS

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01

Epoch Labs

India
CPHI Middle east
Not Confirmed
arrow

Epoch Labs

India
CPHI Middle east
Not Confirmed
arrow

CAS Number : 319460-85-0

End Use API : Axitinib

About The Company : Epoch-Labs is a Hyderabad, India based Research Organization that gives science administrations to expansive pharmaceutical organization, agrochemical organizat...

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02

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 944835-85-2

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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03

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 886230-77-9

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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04

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 261953-36-0

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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05

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 70315-70-7

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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06

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 2527-58-4

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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07

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 20054-45-9

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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08

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 20054-45-9

End Use API : Axitinib

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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09

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 70315-70-7

End Use API : Axitinib

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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10

CPHI Middle east
Not Confirmed
arrow
CPHI Middle east
Not Confirmed
arrow

CAS Number : 319460-85-0

End Use API : Axitinib

About The Company : Jinan Xinke Pharmaceutical Science and Technology Co., Ltd. (XKPHARM) is an innovation driven company, headquartered in Jinan city, Shandong province, China and...

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FDA Orange Book

read-more
read-more

01

APOTEX INC

Canada
CPHI Middle east
Not Confirmed
arrow

APOTEX INC

Canada
arrow
CPHI Middle east
Not Confirmed

AXITINIB

Brand Name : AXITINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date :

Application Number : 211650

RX/OTC/DISCN :

RLD :

TE Code :

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02

APOTEX INC

Canada
CPHI Middle east
Not Confirmed
arrow

APOTEX INC

Canada
arrow
CPHI Middle east
Not Confirmed

AXITINIB

Brand Name : AXITINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date :

Application Number : 211650

RX/OTC/DISCN :

RLD :

TE Code :

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03

PF PRISM CV

U.S.A
CPHI Middle east
Not Confirmed
arrow

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

Brand Name : INLYTA

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2012-01-27

Application Number : 202324

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

PF PRISM CV

U.S.A
CPHI Middle east
Not Confirmed
arrow

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

Brand Name : INLYTA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2012-01-27

Application Number : 202324

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

TEVA PHARMS

Israel
CPHI Middle east
Not Confirmed
arrow

TEVA PHARMS

Israel
arrow
CPHI Middle east
Not Confirmed

AXITINIB

Brand Name : AXITINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date :

Application Number : 210234

RX/OTC/DISCN :

RLD :

TE Code :

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06

TEVA PHARMS

Israel
CPHI Middle east
Not Confirmed
arrow

TEVA PHARMS

Israel
arrow
CPHI Middle east
Not Confirmed

AXITINIB

Brand Name : AXITINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date :

Application Number : 210234

RX/OTC/DISCN :

RLD :

TE Code :

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Controlled & Modified Release

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Coloring Agents

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NEWS #PharmaBuzz

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Global Sales Information

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Finished Drug Prices

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01

Brand Name : Inlyta

Denmark
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

Denmark
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Price Per Pack (Euro) : 4,622.66

Published in :

Country : Norway

RX/OTC/DISCN :

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02

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 1 mg

Price Per Pack (Euro) : 928.99

Published in :

Country : Norway

RX/OTC/DISCN :

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03

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 3 mg

Price Per Pack (Euro) : 3,076.63

Published in :

Country : Norway

RX/OTC/DISCN :

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04

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Price Per Pack (Euro) : 4,622.66

Published in :

Country : Norway

RX/OTC/DISCN :

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05

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 7 mg

Price Per Pack (Euro) : 6,529.60

Published in :

Country : Norway

RX/OTC/DISCN :

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06

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Axitinib 1Mg 56 Combined Oral Us...

Dosage Strength : 56 cpr riv 1 mg

Price Per Pack (Euro) : 1,317.03

Published in :

Country : Italy

RX/OTC/DISCN : Class H

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07

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Axitinib 3Mg 56 Combined Oral Us...

Dosage Strength : 56 cpr riv 3 mg

Price Per Pack (Euro) : 3,951.11

Published in :

Country : Italy

RX/OTC/DISCN : Class H

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08

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Axitinib 5Mg 56 Combined Oral Us...

Dosage Strength : 56 cpr riv 5 mg

Price Per Pack (Euro) : 6,585.15

Published in :

Country : Italy

RX/OTC/DISCN : Class H

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09

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Axitinib 7Mg 56 Combined Oral Us...

Dosage Strength : 56 cpr riv 7 mg

Price Per Pack (Euro) : 9,219.22

Published in :

Country : Italy

RX/OTC/DISCN : Class H

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10

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Brand Name : Inlyta

U.S.A
arrow
CPHI Middle east
Not Confirmed

Axitinib

Dosage Form : Filmtabl

Dosage Strength : 1mg

Price Per Pack (Euro) : 682.69

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Market Place

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APIs

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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read-more

01

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 10570202

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code : U-2844

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-02-03

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02

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 6534524*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-10-29

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03

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 10570202

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code : U-2844

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-02-03

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04

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 8791140*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-06-14

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05

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 10869924

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code : U-3044

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-01-12

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06

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 8791140*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-06-14

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07

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 10869924

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code : U-3044

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-01-12

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08

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 10869924*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-07-12

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09

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 8791140

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 202324

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-12-14

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10

arrow
CPHI Middle east
Not Confirmed

PF PRISM CV

U.S.A
arrow
CPHI Middle east
Not Confirmed

AXITINIB

US Patent Number : 10869924*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 202324

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-07-12

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