HIF prolyl-hydroxylase inhibitor explained

Atc Prefix:B03X
Mechanism Of Action:Enzyme inhibitor
Biological Target:HIF prolyl-hydroxylase

Not to be confused with Factor Inhibiting HIF Asparaginyl Hydroxylase Inhibitors

Hypoxia-inducible factor prolyl hydroxylase Inhibitors (HIF-PHIs) also known as hypoxia-inducible factor stabilizers (HIF stabilizers) are a novel class of drugs that act by inhibiting hypoxia-inducible factor-proline dioxygenase (HIF prolyl-hydroxylase) which is responsible for breaking down the hypoxia-inducible factor (HIF) under conditions of normal oxygen concentrations.

As of 2023, Vadadustat, Daprodustat, and Roxadustat are the most studied HIF-PHIs with highest number of phase III & Phase IV patient data for chronic kidney disease.[1] [2] All the three drug are available in Japan, while Vadadustat & Daprodustat is under EU regulatory review for potential approval in 2023. US FDA approved Daprodustat in early 2023 after a positive adcom for favorable benefit-risk ratio, while Vadadustat is awaiting an even-handed response to its formal dispute resolution appeal, considering recent FDA approval of Daprodustat.[3]

Outside of chronic kidney disease, Akebia Therapeutics has reported initial findings from its phase II study evaluating Vadadustat for ARDS in Covid-19 patients.[4] Based on the results Akebia Therapeutics has decided to move forward with a phase III study in broader ARDS patients.[5]

The rights to Vadadustat is held by Akebia Therapeutics in partnership with CSL Vifor, Roxadustat by Fibrogen in partnership with Astellas, and Daprodustat has been internally developed by GSK.[6] [7]

Examples

See also

Notes and References

  1. Chen . Dinghua . Niu . Yue . Liu . Fei . Yang . Yue . Wang . Xue . Li . Ping . Chen . Xiangmei . 2022-12-29 . Safety of HIF Prolyl-Hydroxylase Inhibitors for Anemia in Dialysis Patients: A Systematic Review and Network Meta-Analysis . Authorea Preprints . 10.22541/au.167229660.07194141. 31 January 2024 .
  2. Zheng . Qiyan . Wang . Yahui . Yang . Huisheng . Sun . Luying . Zhang . Pingna . Zhang . Xueqin . Guo . Jing . Liu . Yu Ning . Liu . Wei Jing . 2022-11-15 . Cardiac and Kidney Adverse Effects of HIF Prolyl-Hydroxylase Inhibitors for Anemia in Patients With CKD Not Receiving Dialysis: A Systematic Review and Meta-analysis . American Journal of Kidney Diseases . 81 . 4 . 434–445.e1 . en . 10.1053/j.ajkd.2022.09.014 . 36396085 . 253570576 . 0272-6386.
  3. Web site: HIF-PHI-delity? As FDA spins new tune in CKD anemia with GSK nod, others in class may hope to play along BioWorld . 2023-02-15 . www.bioworld.com . en.
  4. Therapeutics . Akebia . Akebia Therapeutics Announces Initial Findings from Investigator-Sponsored Clinical Study Evaluating Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Subjects with COVID-19 and Hypoxemia (VSTAT) . 2023-02-15 . www.prnewswire.com . en.
  5. Web site: Transcripts . S. A. . 2022-11-03 . Akebia Therapeutics, Inc. (AKBA) Q3 2022 Earnings Call Transcript Seeking Alpha . 2023-02-15 . seekingalpha.com . en.
  6. Web site: vadadustat . 2023-02-15 . CSL Vifor . en-GB.
  7. Web site: Astellas Receives European Commission Approval for First-in-Class EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease . 2023-02-15 . Astellas Pharma US, Inc. News Room . en.

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