NDAORALTABLET
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
27
Data completeness
4/8 — Partial
VAFSEO (vadadustat) by Akebia Therapeutics is hypoxia-inducible factor prolyl hydroxylase inhibitors [moa]. First approved in 2024.
Drug data last refreshed 11h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VAFSEO (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved March 2024 for treating anemia in patients with end-stage renal disease (ESRD). It works by stabilizing HIF, which increases endogenous erythropoietin production without requiring IV administration. This represents a novel, oral alternative to traditional ESA therapies.
Growth9.5 years to LOE
Early growth-stage oral therapeutic in underserved dialysis market with potential for rapid team expansion and market establishment.
Mechanism of Action
Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors
Pharmacologic Class:
Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (27)
Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis
Started Apr 2026
100 enrolled
Anemia Associated With Chronic Kidney Disease
Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury
Started Oct 2025
1,100 enrolled
Nonintubated Acute Respiratory Distress Syndrome (ARDS)Pathogen-associated Lung Injury
To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
Started Jul 2025
353 enrolled
Anemia of Chronic Kidney Disease
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease
Started Jan 2025
0Anemia of Chronic Kidney Disease
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
Started Jan 2025
0Anemia of Chronic Kidney Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.