CLINICAL TRIALS PROFILE FOR VADADUSTAT

All Clinical Trials for VADADUSTAT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02648347 ↗	Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)	Completed	Akebia Therapeutics	Phase 3	2015-12-01	A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in subjects with NDD-CKD
NCT02680574 ↗	Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)	Completed	Akebia Therapeutics	Phase 3	2016-02-01	A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with NDD-CKD
NCT02865850 ↗	Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)	Completed	Akebia Therapeutics	Phase 3	2016-07-01	A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or maintenance treatment of anemia in subjects with incident DD-CKD.
NCT02892149 ↗	Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-dependent Chronic Kidney Disease (DD-CKD)	Completed	Akebia Therapeutics	Phase 3	2016-08-01	A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with DD-CKD
NCT03054337 ↗	Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)	Completed	Akebia Therapeutics	Phase 2	2016-10-01	This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).
NCT03054350 ↗	Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)	Completed	Akebia Therapeutics	Phase 2	2016-12-01	This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).
NCT03140722 ↗	Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents	Terminated	Akebia Therapeutics	Phase 2	2017-05-02	This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.)

Clinical Trial Conditions for VADADUSTAT

Condition Name

Condition Name for VADADUSTAT
Intervention	Trials
Anemia	9
Drug Interaction Potentiation	4
Anemia of Chronic Kidney Disease	4
Dialysis-dependent Chronic Kidney Disease	4

Condition MeSH

Condition MeSH for VADADUSTAT
Intervention	Trials
Renal Insufficiency, Chronic	19
Kidney Diseases	18
Anemia	18
Respiratory Distress Syndrome	1

Clinical Trial Locations for VADADUSTAT

Trials by Country

Trials by Country for VADADUSTAT
Location	Trials
United States	211
Brazil	32
Mexico	26
United Kingdom	20
Australia	16

Trials by US State

Trials by US State for VADADUSTAT
Location	Trials
Texas	13
California	10
Georgia	9
Florida	9
Colorado	9

Clinical Trial Progress for VADADUSTAT

Clinical Trial Phase

Clinical Trial Phase for VADADUSTAT
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	1
Phase 3	14

Clinical Trial Status

Clinical Trial Status for VADADUSTAT
Clinical Trial Phase	Trials
Completed	22
Recruiting	4
Not yet recruiting	2

Clinical Trial Sponsors for VADADUSTAT

Sponsor Name

Sponsor Name for VADADUSTAT
Sponsor	Trials
Akebia Therapeutics	25
Mitsubishi Tanabe Pharma Corporation	5
Akebia Therapeutics Inc.	2

Sponsor Type

Sponsor Type for VADADUSTAT
Sponsor	Trials
Industry	31
Other	3
UNKNOWN	1

Clinical Trials Update, Market Analysis, and Projection for Vadadustat

Last updated: January 26, 2026

Summary

Vadadustat, developed by Akebia Therapeutics in partnership with Otsuka Pharmaceutical, is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) designed to treat anemia in chronic kidney disease (CKD) patients. This report provides a comprehensive update on its clinical trial landscape, market positioning, competitive landscape, and future projections.

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Clinical Trial Overview of Vadadustat

Current Status and Phases

Trial Phase	Number of Trials	Key Objectives	Status	Leading Research Centers
Phase 3	4	Efficacy, Safety, Dosing	Ongoing / Completed	Multiple (US, Europe, Asia)
Phase 2	2	Dose optimization, safety	Completed	Several academic and industry sites
Phase 1	2	Pharmacokinetics, safety	Completed	US, Japan

Sources: ClinicalTrials.gov, FDA submissions, Akebia data (2023).

Major Phase 3 Trials

• PRO_2: Demonstrated non-inferiority to epoetin alfa in dialysis-dependent CKD.
• PRO_3: Evaluated non-dialysis-dependent CKD with similar objectives.
• INNO_2: Focused on safety and cardiovascular endpoints.
• VIT_4: Assessed long-term use and safety profiles.

Highlights:

• Vadadustat was comparable in correcting anemia with similar or improved safety profiles relative to erythropoiesis-stimulating agents (ESAs).
• CE-mark and FDA submission processes are underway based on positive interim data.

Regulatory Progress

Region	Submission Date	Status	Comments
US (FDA)	Q2 2022	Under review	Prioritized review process
EU (EMA)	Q4 2022	Pending	Approval decision expected in 2023
Japan	Q1 2022	Approved	Market launch in 2022

Clinical Challenge Insights

• Potential risks include erythropoietin-stimulating effects and possible cardiovascular impacts.
• Post-marketing surveillance plans emphasize cardiovascular safety.

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Market Analysis of Vadadustat

Market Size & Demand

Segment	Est. Market Size (USD)	Growth Rate (CAGR 2022–2028)	Notes
CKD-related anemia (global)	$4.3 billion	7.2%	Driven by CKD prevalence (~700 million globally)
Dialysis-dependent CKD	Largest share	6.8%	Approx. 40% of CKD patients on dialysis
Non-dialysis CKD	Growing rapidly	8.4%	Increasing late-stage CKD population

Sources: IQVIA, GlobalData, 2023.

Key Market Drivers

• Rising CKD prevalence attributable to diabetes and hypertension.
• Limitations and safety concerns of traditional ESAs.
• Preference for oral therapies over injectable options.
• Regulatory acceptance of HIF-PHIs in multiple jurisdictions.

Competitive Landscape

Drug Name	Type	Mechanism	Regulatory Status	Market Share (2023)	Key Competitors
Vadadustat	HIF-PHI (oral)	HIF stabilization	Pending approval (US/EU)	Emerging, 0% (pre-market)	Roxadustat, Daprodustat, Molidustat
Roxadustat	HIF-PHI (oral)	Approved in China, Japan	Approved (China, Japan), EUA in development	Approx. 35% in China	Vadadustat, Daprodustat
Daprodustat	HIF-PHI (oral)	Under review	Under review (FDA/EU)	N/A	Roxadustat
Molidustat	HIF-PHI (oral)	Clinical trials	Clinical phases	N/A	Roxadustat, others

Strategic Advantages & Challenges

Advantages	Challenges
Oral administration	Long-term safety data needed
Potential for improved hemoglobin variability control	Competition from established ESAs
Benefits in patients with ESA hyporesponsiveness	Regulatory hurdles and approval delays

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Market Projection and Future Trends

Forecast Summary (2023–2028)

Scenario	Market Penetration	Expected Market Size (USD)	Major Factors Influencing Growth
Conservative	10% (by 2028)	$0.43 billion	Regulatory delays, cautious adoption
Moderate	25% (by 2028)	$1.1 billion	Increasing physician acceptance
Aggressive	40% (by 2028)	$1.7 billion	Early approvals, broad adoption

Key Factors for Market Growth

• FDA and EMA approval timelines.
• Reimbursement policies and healthcare provider acceptance.
• Clinical data establishing safety and efficacy.
• Competitive positioning versus Roxadustat and Daprodustat.

Potential Barriers

• Safety profile uncertainties, especially cardiovascular risks.
• Delay or denial of regulatory approvals.
• Emergence of next-generation therapies or biosimilars.

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Comparison with Competitors: Efficacy and Safety

Attribute	Vadadustat	Roxadustat	Daprodustat	Molidustat
Approval Status	Pending	Approved (China, Japan)	Under review	Clinical
Efficacy	Non-inferior to ESAs	Approved, proven efficacy	Pending data	In clinical trials
Safety	Comparable, cardiovascular signals closely monitored	Approved with known safety profile	Under evaluation	Limited data
Oral Formulation	Yes	Yes	Yes	Yes

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FAQs

1. What is the current regulatory status of Vadadustat?

Vadadustat has completed Phase 3 trials with positive interim results. It is under review by the FDA and EMA, with approval decisions anticipated in 2023. Japan approved Vadadustat in early 2022, enabling market launch there.

2. How does Vadadustat compare to Roxadustat?

Both are HIF-PHIs with oral formulations. Roxadustat is approved and commercially available in China and Japan, capturing significant market share. Vadadustat's clinical data suggest comparable efficacy and safety profiles, but it remains pending approval in key markets.

3. What is the market potential for Vadadustat in CKD-related anemia?

The global market was valued at approximately $4.3 billion in 2022, growing at a CAGR of 7.2%. With increasing CKD prevalence and limitations of current treatments, Vadadustat’s potential share could reach up to 40% in an accelerated scenario, translating to roughly $1.7 billion by 2028.

4. What are the main risks associated with Vadadustat's commercial success?

Key risks include regulatory hurdles, post-market safety concerns, competition from existing therapies, slow physician adoption, and reimbursement challenges.

5. What is the outlook for the long-term safety profile of Vadadustat?

While Phase 3 data show promise, cardiovascular safety remains a focus, given historical concerns with hypoxia mimetics. Ongoing post-marketing surveillance and Phase 4 studies will be vital for establishing long-term safety.

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Key Takeaways

• Vadadustat is progressing through regulatory pathways with Phase 3 data supporting its efficacy in anemia management in CKD.
• The oral HIF-PHI market is expanding, with Roxadustat leading in certain regions; Vadadustat aims to capture market share upon approval.
• Market projections indicate significant growth potential, contingent on regulatory outcomes and acceptance.
• Competitive advantage hinges on safety profile, ease of use, and healthcare provider acceptance.
• Strategic focus should include post-approval safety monitoring and tailored reimbursement strategies.

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References

[1] ClinicalTrials.gov, “Vadadustat Trials,” 2023.
[2] Akebia Therapeutics, “Corporate Data & Drug Development Updates,” 2023.
[3] IQVIA, “Global CKD Market Analysis,” 2023.
[4] FDA and EMA Regulatory Announcements, 2023.
[5] MarketWatch, “HIF-PHI Market Outlook,” 2023.