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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

EU WC

EU WC

0

KDMF

KDMF

0

NDC API

NDC API

0

VMF

NDC API

API REF. PRICE (USD/KG)

$
$ 0

MARKET PLACE

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FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Canada

Canada

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Australia

Australia

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South Africa

South Africa

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Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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Health Canada Patents

GLOBAL SALES INFORMATION

US Medicaid

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Finished Drug Prices

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0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1000025-07-9, Akb-6548, Pg-1016548, Vadadustat [usan], N-(5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl)glycine, B506
Molecular Formula
C14H11ClN2O4
Molecular Weight
306.70  g/mol
InChI Key
JGRXMPYUTJLTKT-UHFFFAOYSA-N
FDA UNII
I60W9520VV

Vadadustat
Vadadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor (HIF-PHI), with potential anti-anemic and anti-inflammatory activities. Upon administration, vadadustat binds to and inhibits HIF-PH, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. This prevents HIF breakdown and promotes HIF activity. Increased HIF activity leads to an increase in endogenous erythropoietin production, thereby enhancing erythropoiesis. It also reduces the expression of the peptide hormone hepcidin, improves iron availability, and boosts hemoglobin (Hb) levels. HIF regulates the expression of genes in response to reduced oxygen levels, including genes required for erythropoiesis and iron metabolism. In addition, HIF 1-alpha (HIF1A) may play a role in reducing inflammation during acute lung injury (ALI) through HIF-dependent control of glucose metabolism in the alveolar epithelium.
1 2D Structure

Vadadustat

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid
2.1.2 InChI
InChI=1S/C14H11ClN2O4/c15-10-3-1-2-8(4-10)9-5-11(18)13(16-6-9)14(21)17-7-12(19)20/h1-6,18H,7H2,(H,17,21)(H,19,20)
2.1.3 InChI Key
JGRXMPYUTJLTKT-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC(=CC(=C1)Cl)C2=CC(=C(N=C2)C(=O)NCC(=O)O)O
2.2 Other Identifiers
2.2.1 UNII
I60W9520VV
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Akb-6548

2.3.2 Depositor-Supplied Synonyms

1. 1000025-07-9

2. Akb-6548

3. Pg-1016548

4. Vadadustat [usan]

5. N-(5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl)glycine

6. B506

7. Pg1016548

8. B-506

9. Akb6548

10. (5-(3-chlorophenyl)-3-hydroxypicolinoyl)glycine

11. I60w9520vv

12. 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic Acid

13. Glycine, N-((5-(3-chlorophenyl)-3-hydroxy-2-pyridinyl)carbonyl)-

14. Glycine, N-[[5-(3-chlorophenyl)-3-hydroxy-2-pyridinyl]carbonyl]-

15. Vafseo

16. Glycine, N-[[5-(3-chlorophenyl)-3-hydroxy-2-pyridinyl]carbonyl]-;glycine, N-[[5-(3-chlorophenyl)-3-hydroxy-2-pyridinyl]carbonyl]-

17. Unii-i60w9520vv

18. Us8722895, 11: {[5-(3-chlorophenyl)-3-hydroxypyridine-2- Carbonyl]amino}-acetic Acid

19. A1z

20. Vafseo (tn)

21. Vadadustat [inn]

22. Vadadustat [jan]

23. Us8722895, 10: {[5-(3-chlorophenyl)-3-hydroxypyridine-2- Carbonyl]amino}-acetic Acid Trifluoroacetic Acid Salt

24. Vadadustat [who-dd]

25. Vadadustat (jan/usan/inn)

26. Schembl1920738

27. Chembl3646221

28. Gtpl11831

29. Bdbm107704

30. Dtxsid501179936

31. Amy27885

32. Bcp19497

33. Ex-a2573

34. 2-{[5-(3-chlorophenyl)-3-hydroxypyridin-2-yl]formamido}acetic Acid

35. Gsk128863

36. S6490

37. Zinc117532869

38. Cs-6373

39. Db12255

40. Sb19204

41. Us8598210, Table Xv, 10

42. Us8598210, Table Xv, 11

43. Ac-30928

44. As-71695

45. Db-102455

46. Hy-101277

47. Vadadustat; Pg-1016548; Akb-6548

48. J3.560.572j

49. C71001

50. D11078

51. Us8598210, 119

52. Q27280485

53. 2-(5-(3-chlorophenyl)-3-hydroxypicolinamido)acetic Acid

54. Akb-6548; B-506; Pg-1016548

55. {[5-(3-chlorophenyl)-3-hydroxy-pyridine-2-carbonyl]-amino}-acetic Acid

56. {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}-acetic Acid

2.4 Create Date
2008-01-07
3 Chemical and Physical Properties
Molecular Weight 306.70 g/mol
Molecular Formula C14H11ClN2O4
XLogP32.5
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count4
Exact Mass306.0407345 g/mol
Monoisotopic Mass306.0407345 g/mol
Topological Polar Surface Area99.5 Ų
Heavy Atom Count21
Formal Charge0
Complexity393
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of anaemia due to chronic disorders


5 Pharmacology and Biochemistry
5.1 ATC Code

B - Blood and blood forming organs

B03 - Antianemic preparations

B03X - Other antianemic preparations

B03XA - Other antianemic preparations

B03XA08 - Vadadustat


API SUPPLIERS

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01

Metrochem API Private Limited

India

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

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CPHI Middle east
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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

02

Ami Lifesciences Private Limited

India

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

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CPHI Middle east
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
AMI Lifesciences

03

Shanvr Life Sciences

India

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

CPHI Middle east
Not Confirmed
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04

Viatris

U.S.A

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

CPHI Middle east
Not Confirmed
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Viatris

U.S.A

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

arrow
CPHI Middle east
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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Listed Suppliers

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CPHI Middle east
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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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Digital Content Digital Content

Vadadustat

About the Company :

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Metrochem

02

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CPHI Middle east
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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Digital Content Digital Content

Vadadustat

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
AMI Lifesciences

03

CPHI Middle east
Not Confirmed
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Vadadustat

About the Company : Shanvr Life Sciences Pvt Ltd is a pharmaceutical product development company with a strong emphasis on research. Our approach centers around the creation of specialized generic, on...

Shanvr Life Sciences Pvt Ltd is a pharmaceutical product development company with a strong emphasis on research. Our approach centers around the creation of specialized generic, oncology, and specialty pharmaceuticals, utilizing various business models tailored to meet client needs. We collaborate with prominent national and international drug developers and manufacturers, providing them with cutting-edge development solutions and capabilities to ensure the production of safe drugs. As an R&D-focused enterprise,it is dedicated to the development of new generic pharmaceuticals and investigational medicinal products.
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04

Viatris

U.S.A
CPHI Middle east
Not Confirmed
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Viatris

U.S.A
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Not Confirmed

Vadadustat

About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...

In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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Drugs in Development

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Details:

The agreement aims to enable access to Vafseo (vadadustat), a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for patients on dialysis.


Lead Product(s): Vadadustat

Therapeutic Area: Hematology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: U.S. Renal Care

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 07, 2024

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01

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : The agreement aims to enable access to Vafseo (vadadustat), a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for patients on dialysis.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 07, 2024

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Details:

Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor. It is approved for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.


Lead Product(s): Vadadustat

Therapeutic Area: Nephrology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: U.S. Renal Care

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 05, 2024

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02

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor. It is approved for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 05, 2024

blank

Details:

Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. It is approved for anemia due to chronic kidney disease in adult patients on dialysis.


Lead Product(s): Vadadustat

Therapeutic Area: Nephrology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 11, 2024

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03

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. It is approved for anemia due to chronic kidney disease in adult patients on dialysis.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 11, 2024

blank

Details:

Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. It is approved for anemia due to chronic kidney disease in adult patients on dialysis.


Lead Product(s): Vadadustat

Therapeutic Area: Nephrology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: CSL Vifor

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 27, 2024

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04

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. It is approved for anemia due to chronic kidney disease in adult patients on dialysis.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 27, 2024

blank

Details:

Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to treat anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Vadadustat is currently approved for use in 35 countries.


Lead Product(s): Vadadustat

Therapeutic Area: Nephrology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 28, 2023

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05

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to treat anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Vadadustat is currently approved for use in 35 countries.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 28, 2023

blank

Details:

Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. Vadadustat is currently approved for use in 34 countries.


Lead Product(s): Vadadustat

Therapeutic Area: Hematology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 26, 2023

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06

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. Vadadustat is currently approved for use in 34 countries.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 26, 2023

blank

Details:

Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. Vadadustat is currently approved for use in 34 countries.


Lead Product(s): Vadadustat

Therapeutic Area: Hematology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2023

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07

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. Vadadustat is currently approved for use in 34 countries.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 24, 2023

blank

Details:

Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. It is being developed for the treating symptomatic anaemia associated with CKD.


Lead Product(s): Vadadustat

Therapeutic Area: Hematology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 20, 2023

blank

08

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. It is being developed for the treating symptomatic anaemia associated with CKD.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 20, 2023

blank

Details:

Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, approved for use in 33 countries for the treatment of symptomatic anemia associated with CKD, received a written response from FDA stating denial of formal dispute resolution regarding the CRL.


Lead Product(s): Vadadustat

Therapeutic Area: Hematology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 30, 2023

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09

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Details : Vafseo (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, approved for use in 33 countries for the treatment of symptomatic anemia associated with CKD, received a written response from FDA stating denial of formal dispute resolu...

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 30, 2023

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Details:

Under the agreement, Medice to market Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor developed by Akebia to treat anemia due to chronic kidney disease (CKD), in Europe.


Lead Product(s): Vadadustat

Therapeutic Area: Nephrology Brand Name: Vafseo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Medice Arzneimittel Pütter GmbH&Co.KG

Deal Size: $110.0 million Upfront Cash: $10.0 million

Deal Type: Licensing Agreement May 25, 2023

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10

Antibody Engineering
Not Confirmed
Antibody Engineering
Not Confirmed

Lead Product(s) : Vadadustat

Therapeutic Area : Nephrology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Medice Arzneimittel Pütter GmbH&Co.KG

Deal Size : $110.0 million

Deal Type : Licensing Agreement

Details : Under the agreement, Medice to market Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor developed by Akebia to treat anemia due to chronic kidney disease (CKD), in Europe.

Brand Name : Vafseo

Molecule Type : Small molecule

Upfront Cash : $10.0 million

May 25, 2023

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FDF Dossiers

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01

CPHI Middle east
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VADADUSTAT

Brand Name : VAFSEO

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2024-03-27

Application Number : 215192

Regulatory Info : RX

Registration Country : USA

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02

CPHI Middle east
Not Confirmed
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CPHI Middle east
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VADADUSTAT

Brand Name : VAFSEO

Dosage Form : TABLET;ORAL

Dosage Strength : 300MG

Packaging :

Approval Date : 2024-03-27

Application Number : 215192

Regulatory Info : RX

Registration Country : USA

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03

CPHI Middle east
Not Confirmed
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CPHI Middle east
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VADADUSTAT

Brand Name : VAFSEO

Dosage Form : TABLET;ORAL

Dosage Strength : 450MG

Packaging :

Approval Date : 2024-03-27

Application Number : 215192

Regulatory Info : RX

Registration Country : USA

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Global Sales Information

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Annual Reports

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01

Brand Name : Vafseo

Vadadustat

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Antibody Engineering
Not Confirmed

Brand Name : Vafseo

Japan
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Antibody Engineering
Not Confirmed

Vadadustat

Main Therapeutic Indication : Nephrology

Currency : USD

2021 Revenue in Millions : 7

2020 Revenue in Millions : 0

Growth (%) : 100

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02

Brand Name : Vafseo

Vadadustat

arrow
Antibody Engineering
Not Confirmed

Brand Name : Vafseo

Japan
arrow
Antibody Engineering
Not Confirmed

Vadadustat

Main Therapeutic Indication : Nephrology

Currency : USD

2022 Revenue in Millions : 15

2021 Revenue in Millions : 8

Growth (%) : 79

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03

Brand Name : Vafseo

Vadadustat

arrow
Antibody Engineering
Not Confirmed

Brand Name : Vafseo

Japan
arrow
Antibody Engineering
Not Confirmed

Vadadustat

Main Therapeutic Indication : Nephrology

Currency : USD

2023 Revenue in Millions : 15

2022 Revenue in Millions : 15

Growth (%) : 15

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