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Details:
Vafseo (vadadustat) is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) 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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: CSL Vifor
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2024
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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2023
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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 26, 2023
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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2023
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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2023
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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 30, 2023
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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Medice Arzneimittel Pütter GmbH&Co.KG
Deal Size: $110.0 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement May 25, 2023
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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2023
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 Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2023
Details:
The data demonstrated that Vafseo, having vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA in the treatment of anemia due to chronic kidney disease in patients on hemodialysis.
Lead Product(s): Vadadustat
Therapeutic Area: Hematology Product Name: Vafseo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2023
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 Product Name: Vafseo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2023
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 Product Name: Vafseo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2023
Details:
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. Vadadustat is an investigational new drug and is not approved by the U.S. Food and Drug Administration (FDA).
Lead Product(s): Vadadustat
Therapeutic Area: Hematology Product Name: AKB-6548
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2022
Details:
As a result of termination of agreement, Akebia is regaining the rights from Otsuka for AKB-6548 (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in the US, Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: AKB-6548
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: $1,895.0 million Upfront Cash: $198.0 million
Deal Type: Termination June 30, 2022
Details:
Otsuka and Akebia had been co-developing vadadustat for renal anemia, Otsuka has decided to terminate its co-development of vadadustat and has notified Akebia of the termination of its global license agreements.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: AKB-6548
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: $1,895.0 million Upfront Cash: $198.0 million
Deal Type: Termination May 13, 2022
Details:
Vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor under review for the treatment of anemia due to chronic kidney disease (CKD).
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Akebia Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability for the treatment of anemia due to chronic kidney disease.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Details:
The new agreement further supports Akebia's commercialization strategy ahead of a potential first-in-class U.S. launch for vadadustat which, as previously noted, provides access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: CSL Vifor
Deal Size: $45.0 million Upfront Cash: $25.0 million
Deal Type: Licensing Agreement February 22, 2022
Details:
Vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is Akebia's lead product candidate. Program evaluated the safety and efficacy of Vadadustat in adult patients with anemia due to ckd on dialysis and not on dialysis.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2021
Details:
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) Inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. Vadadustat recently completed its global Phase 3 clinical development program for anemia due to CKD.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2021
Details:
INNO2VATE evaluated the efficacy and safety of vadadustat, Akebia's investigational oral HIF-PHI, versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
PRO2TECT data show vadadustat achieved primary and key secondary efficacy endpoints in each study, but did not meet the primary safety endpoint.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the Company reported positive top-line data in May.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is now commercially available in Japan as a treatment for anemia due to chronic kidney disease (CKD) under the trade name VAFSEO™.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2020
Details:
The randomized, double-blind, placebo-controlled study is intended to evaluate the safety and efficacy of vadadustat in up to 300 adult patients who have been hospitalized at Memorial Hermann-Texas Medical Center for hypoxemia due to COVID-19.
Lead Product(s): Vadadustat
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hermann-Texas Medical Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2020
Details:
In both of the two INNO2VATE trials, Vadadustat achieved primary and secondary efficacy endpoints. The cardiovascular outcomes program INNO2VATE, Phase 3 evaluates the efficacy & safety of vadadustat.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2020
Details:
The posters present studies of Akebia's investigational oral HIF-prolyl hydroxylase inhibitor (HIF-PHI), vadadustat.
Lead Product(s): Vadadustat
Therapeutic Area: Nephrology Product Name: Vafseo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Otsuka Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2020
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