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1. Ag 013736
2. Ag-013736
3. Ag013736
4. Inlyta
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
| Molecular Weight | 386.5 g/mol |
|---|---|
| Molecular Formula | C22H18N4OS |
| XLogP3 | 4.2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 5 |
| Exact Mass | 386.12013238 g/mol |
| Monoisotopic Mass | 386.12013238 g/mol |
| Topological Polar Surface Area | 96 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 557 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Inlyta |
| PubMed Health | Axitinib (By mouth) |
| Drug Classes | Antineoplastic Agent |
| Drug Label | INLYTA (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 Ingredient | Axitinib |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 1mg; 5mg |
| Market Status | Prescription |
| Company | Pfizer |
| 2 of 2 | |
|---|---|
| Drug Name | Inlyta |
| PubMed Health | Axitinib (By mouth) |
| Drug Classes | Antineoplastic Agent |
| Drug Label | INLYTA (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 Ingredient | Axitinib |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 1mg; 5mg |
| Market Status | Prescription |
| Company | Pfizer |
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.
Axitinib prevents the progression of cancer by inhibiting angiogenesis and blocking tumor growth.
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.)
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
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.
Axitinib undergoes mainly hepatic metabolism. CYP3A4 and CYP3A5 are the main hepatic enzymes while CYP1A2, CYP2C19, and UGT1A1 enzymes are secondary.
Axitinib has a half life of 2.5 to 6.1 hours.
Axitinib selectively blocks the tyrosine kinase receptors VEGFR-1 (vascular endothelial growth factor receptor), VEGFR-2, and VEGFR-3.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42016
Submission : 2025-11-05
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2016-09-16
Pay. Date : 2016-07-01
DMF Number : 30341
Submission : 2016-03-04
Status : Active
Type : II

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

GDUFA
DMF Review : Complete
Rev. Date : 2016-02-05
Pay. Date : 2015-12-23
DMF Number : 30104
Submission : 2015-12-24
Status : Active
Type : II

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

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39323
Submission : 2023-12-27
Status : Active
Type : II

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0082
Address of the Firm : Karakhadi, Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist -Vadodara, Gujara...

Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm : Unit-I, Sy. No. 10, I.D.A, Gaddapotharam (V), Jinnaram (M), Sangareddy District,...

Date of Issue : 2025-09-19
Valid Till : 2028-05-05
Written Confirmation Number : WC-0349
Address of the Firm : Unit-II, Sy. Nos. 50, 53, 53/A, 54 & 54/A,Kardanur (Village), Patancheru (Mandal...

Date of Issue : 2026-01-01
Valid Till : 2028-07-02
Written Confirmation Number : WC-0147
Address of the Firm : 100% EOU, Plot No.33, 33A, 40 to 47,Block C, D, E, H, I& AM,Raichur Industrial G...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2018-02-08
Registration Number : Su87-23-ND
Manufacturer Name : Pfizer Ireland Pharmaceutica...
Manufacturer Address : Ringaskiddy API Plant, Ringaskiddy, Co. Cork, P43 X336, Ireland

Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2012-08-06
Registration Number : Su189-15-ND
Manufacturer Name : Upjohn Manufacturing Ireland...
Manufacturer Address : Little Island Co. Cork, T45 F627, Ireland

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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
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Details:
OTX-TKI (Axitinib) is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Diabetic Retinopathy.
Lead Product(s): Axitinib,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: OTX-TKI
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 19, 2025

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Lead Product(s) : Axitinib,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : OTX-TKI (Axitinib) is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Diabetic Retinopathy.
Product Name : OTX-TKI
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 19, 2025

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Sasanlimab is a Antibody drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Carcinoma, Renal Cell.
Lead Product(s): Sasanlimab,Palbociclib,Axitinib
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibody, Unconjugated
Sponsor: Stephanie Berg
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 14, 2025

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Lead Product(s) : Sasanlimab,Palbociclib,Axitinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Stephanie Berg
Deal Size : Inapplicable
Deal Type : Inapplicable
A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
Details : Sasanlimab is a Antibody drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Carcinoma, Renal Cell.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
August 14, 2025

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BL-B01D1 is a Other Large Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Kidney Neoplasms.
Lead Product(s): BL-B01D1,Axitinib,Pembrolizumab
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Baili-Bio (Chengdu) Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 08, 2025

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Lead Product(s) : BL-B01D1,Axitinib,Pembrolizumab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Baili-Bio (Chengdu) Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : BL-B01D1 is a Other Large Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Kidney Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 08, 2025

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CLS-AX (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of neovascular age-related macular degeneration.
Lead Product(s): Axitinib,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: CLS-AX
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 06, 2025

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Lead Product(s) : Axitinib,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Clearside Finalizes FDA Alignment for Phase 3 CLS-AX in Wet AMD
Details : CLS-AX (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of neovascular age-related macular degeneration.
Product Name : CLS-AX
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 06, 2025

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Details:
CLS-AX (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of neovascular age-related macular degeneration.
Lead Product(s): Axitinib,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: CLS-AX
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 10, 2025

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Lead Product(s) : Axitinib,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Clearside Biomedical Shares CLS-AX Phase 2b Data at Angiogenesis 2025 Meeting
Details : CLS-AX (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of neovascular age-related macular degeneration.
Product Name : CLS-AX
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 10, 2025

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AIV001 (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of nonmelanoma skin cancer.
Lead Product(s): Axitinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: IND EnablingProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 09, 2024

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Lead Product(s) : Axitinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AiViva Receives FDA Clearance for AIV001 in Nonmelanoma Skin Cancer
Details : AIV001 (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of nonmelanoma skin cancer.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 09, 2024

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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,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Axpaxli
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 15, 2024

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Lead Product(s) : Axitinib,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Ocular Therapeutix™ Speeds SOL-1 Trial of AXPAXLI™ in Wet AMD
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.
Product Name : Axpaxli
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 15, 2024

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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,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: CLS-AX
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 09, 2024

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Lead Product(s) : Axitinib,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Clearside Announces Positive Results in ODYSSEY Phase 2b Trial For Wet AMD
Details : CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.
Product Name : CLS-AX
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 09, 2024

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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,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: CLS-AX
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 27, 2024

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Lead Product(s) : Axitinib,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Clearside Biomedical Completes ODYSSEY Phase 2b Trial for CLS-AX in Wet AMD
Details : CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.
Product Name : CLS-AX
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 27, 2024

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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,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Axpaxli
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2024

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Lead Product(s) : Axitinib,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Ocular Therapeutix™ Receives FDA Feedback on SOL-R Trial for Wet AMD
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.
Product Name : Axpaxli
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 07, 2024

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]2,2'-Dithio-2,2-Bis (N-Methylbenzamide)
CAS Number : 2527-58-4
End Use API : Axitinib
About The Company : Rampex Labs, founded in 2004, is a fully cGMP-compliant pharmaceutical manufacturer with two USFDA-approved facilities in Hyderabad and Vizag, India. The Hydera...
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...

2-(1H-indazol-6-ylthio)-N-methyl-Benzamide
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...

6-Iodo-3(E)-2-pyridin-2-yl-vinyl)-1-(tetrahydropyr...
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...

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...

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...

2,2'-disulfanediylbis(N-methylbenzamide)
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...

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...

N -methyl-2 -sulfanylbenzamide
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...

3-Iodo-6-nitromdazole
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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Regulatory Info : RX
Registration Country : USA
Brand Name : AXITINIB
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Packaging :
Approval Date : 2025-10-30
Application Number : 211650
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : AXITINIB
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2025-10-30
Application Number : 211650
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey

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Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey

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Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 7MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey

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Regulatory Info : RX
Registration Country : USA
Brand Name : INLYTA
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Packaging :
Approval Date : 2012-01-27
Application Number : 202324
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : INLYTA
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2012-01-27
Application Number : 202324
Regulatory Info : RX
Registration Country : USA

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Regulatory Info :
Registration Country : Italy
Brand Name : Inlyta
Dosage Form : Axitinib 1Mg 56 Combined Oral Use
Dosage Strength : 56 cpr riv 1 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : USA
Brand Name : AXITINIB
Dosage Form : TABLET
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 219705
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Brand Name : AXITINIB
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 210234
Regulatory Info :
Registration Country : USA

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PharmaCompass offers a list of Axitinib 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 Axitinib manufacturer or Axitinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Axitinib manufacturer or Axitinib supplier.
PharmaCompass also assists you with knowing the Axitinib API Price utilized in the formulation of products. Axitinib API Price is not always fixed or binding as the Axitinib Price is obtained through a variety of data sources. The Axitinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Axitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Axitinib, including repackagers and relabelers. The FDA regulates Axitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Axitinib 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 Axitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Axitinib supplier is an individual or a company that provides Axitinib active pharmaceutical ingredient (API) or Axitinib finished formulations upon request. The Axitinib suppliers may include Axitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Axitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Axitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Axitinib active pharmaceutical ingredient (API) in detail. Different forms of Axitinib DMFs exist exist since differing nations have different regulations, such as Axitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Axitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Axitinib USDMF includes data on Axitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Axitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Axitinib suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Axitinib Drug Master File in Korea (Axitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Axitinib. The MFDS reviews the Axitinib KDMF as part of the drug registration process and uses the information provided in the Axitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Axitinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Axitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Axitinib suppliers with KDMF on PharmaCompass.
A Axitinib written confirmation (Axitinib WC) is an official document issued by a regulatory agency to a Axitinib manufacturer, verifying that the manufacturing facility of a Axitinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Axitinib APIs or Axitinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Axitinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Axitinib suppliers with Written Confirmation (WC) on PharmaCompass.
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 Axitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Axitinib API and other APIs are published in this directory by the FDA.
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 Axitinib 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.
The NDC directory also contains data on finished compounded human drug products that contain Axitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Axitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Axitinib suppliers with NDC on PharmaCompass.
Axitinib 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 Axitinib 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 Axitinib GMP manufacturer or Axitinib GMP API supplier for your needs.
A Axitinib CoA (Certificate of Analysis) is a formal document that attests to Axitinib's compliance with Axitinib specifications and serves as a tool for batch-level quality control.
Axitinib CoA mostly includes findings from lab analyses of a specific batch. For each Axitinib 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.
Axitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Axitinib EP), Axitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Axitinib USP).