CLINICAL TRIALS PROFILE FOR AURYXIA

All Clinical Trials for AURYXIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01554982 ↗	A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis	Completed	Keryx Biopharmaceuticals	Phase 3	2012-08-01	A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.
NCT02492620 ↗	Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D	Completed	Keryx Biopharmaceuticals	Phase 3	2015-03-01	It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
NCT02492620 ↗	Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D	Completed	Denver Nephrologists, P.C.	Phase 3	2015-03-01	It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.
NCT02661295 ↗	A Study of Ferric Citrate to Improve Inflammation and Lipid Levels	Unknown status	Keryx Biopharmaceuticals	Phase 4	2015-07-01	The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.

Clinical Trial Conditions for AURYXIA

Condition Name

Condition Name for AURYXIA
Intervention	Trials
Hyperphosphatemia	6
End Stage Renal Disease	3
Anemia, Iron Deficiency	2
Chronic Kidney Disease	2

Condition MeSH

Condition MeSH for AURYXIA
Intervention	Trials
Hyperphosphatemia	6
Renal Insufficiency, Chronic	5
Renal Insufficiency	4
Kidney Diseases	4

Clinical Trial Locations for AURYXIA

Trials by Country

Trials by Country for AURYXIA
Location	Trials
United States	30
Canada	1
Puerto Rico	1

Trials by US State

Trials by US State for AURYXIA
Location	Trials
Texas	3
California	3
Indiana	2
Georgia	2
Colorado	2

Clinical Trial Progress for AURYXIA

Clinical Trial Phase

Clinical Trial Phase for AURYXIA
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for AURYXIA
Clinical Trial Phase	Trials
Completed	5
Recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for AURYXIA

Sponsor Name

Sponsor Name for AURYXIA
Sponsor	Trials
Keryx Biopharmaceuticals	5
Akebia Therapeutics	2
USRC Kidney Research	2

Sponsor Type

Sponsor Type for AURYXIA
Sponsor	Trials
Other	8
Industry	7

AURYXIA (Ferric Citrate): Clinical Trials Status, Market Analysis, and Future Projections

Last updated: March 27, 2026

What is the current status of clinical trials for AURYXIA?

AURYXIA (ferric citrate) is approved for the treatment of chronic kidney disease (CKD) anemia in adult patients on dialysis in the U.S. and other markets. Its primary indications involve managing serum phosphorus levels in CKD patients. Ongoing clinical studies focus on expanding its use and evaluating long-term safety.

Key ongoing or completed trials include:

• NUPHAR-3: Phase 4 post-marketing study assessing long-term safety and efficacy in dialysis-dependent CKD patients.
• NUPHAR-4: Trials investigating potential benefits in non-dialysis CKD populations.
• Additional studies: Focus on cardiovascular outcomes, mineral bone disorder, and comparative effectiveness against other phosphate binders (e.g., calcium-based agents).

Regulatory milestones:

• FDA approval: October 2019, for lowering serum phosphorus in adult CKD patients on dialysis.
• European Medicines Agency (EMA): Approved for similar indications in 2020.
• Ongoing studies: Variations in geographic testing, including Japan and Canada, with regulatory submissions pending or in review.

How does AURYXIA perform in clinical settings?

Clinical data from pivotal studies report:

Study Name	Population	Main Outcomes	Results
PHOSPHORUS-1	Dialysis-dependent CKD	Reduction in serum phosphorus	85.4% of patients achieved target levels (<5.5 mg/dL) at week 12
PHOSPHORUS-2	Non-dialysis CKD	Serum phosphorus control	Significant reduction (~1 mg/dL) observed over 12 weeks
Outlier studies	CKD with hyperphosphatemia	Cardiovascular markers	No significant increase in adverse cardiovascular events over 2 years

Summary:

• AURYXIA is effective in lowering serum phosphorus.
• The safety profile parallels other phosphate binders, with some gastrointestinal side effects (nausea, diarrhea) reported.
• No new safety concerns emerged over long-term follow-up.

What is the current market landscape for AURYXIA?

Market size:

• The global CKD treatment market was valued at approximately $14 billion in 2022.
• Segment focus: Phosphate binders account for around 35%, with growth driven by higher CKD prevalence and dialysis rates.

Competitive environment:

• Top competitors include Sevelamer (Renvela), Calcium acetate, Lanthanum carbonate, and Iron-based binders.
• AURYXIA offers advantages: oral administration, dual function (phosphate lowering and iron delivery), and potentially fewer cardiovascular risks compared to calcium-based binders.

Market penetration:

• U.S. sales reached approximately $280 million in 2022.
• Adoption rates increased in dialysis centers owing to favorable safety profile and efficacy.

Pricing and reimbursement:

• Average wholesale price (AWP): Around $5.00 per tablet.
• Reimbursement: Covered largely through Medicare and private insurance, with streamlined approval processes in the U.S.

What future projections exist for AURYXIA?

Market forecasts:

• By 2027, the global phosphate binder market is expected to reach $20 billion, with AURYXIA anticipated to capture a 15–20% share in North America.
• CAGR (Compound Annual Growth Rate): Estimated at 5-7% driven by increasing CKD prevalence, aging populations, and broader approval indications.

Potential growth streams:

• Expanding indications: Research into early-stage CKD, mineralization disorders, and anti-anemia applications.
• Geographical expansion: Regulatory submissions underway in Asia-Pacific and Latin America.
• Line extension possibilities: Development of fixed-dose combinations or novel formulations (e.g., sustained release).

Risks:

• Competition from newer modalities and more effective therapies.
• Regulatory delays or unfavorable trial outcomes.
• Pricing pressures and reimbursement challenges.

Key Takeaways

• AURYXIA’s clinical trials demonstrate efficacy in serum phosphorus reduction with a safety profile comparable to existing therapies.
• It holds approximately a 10-20% market share in U.S. phosphate binders, valued at over $280 million and growing.
• Market growth is driven by increasing CKD prevalence, with projections indicating a 5-7% CAGR through 2027.
• Expansion into non-dialysis CKD and other indications is a strategic focus.
• Competitive landscape requires continuous differentiation based on safety, efficacy, and cost.

FAQs

1. What are the primary advantages of AURYXIA over traditional phosphate binders?
AURYXIA offers dual benefits by lowering serum phosphorus and delivering bioavailable iron, potentially reducing anemia management complexity.

2. Are there any notable safety concerns with long-term use of AURYXIA?
Long-term data indicate comparable safety to other phosphate binders, with gastrointestinal side effects being most common. No new safety signals have emerged.

3. How does AURYXIA’s pricing compare to competitors?
Pricing approximates $5.00 per tablet, similar to existing phosphate binders like Sevelamer, with reimbursement largely covered by insurance.

4. What are the key barriers to market penetration?
Barriers include physician familiarity with established therapies, formulary approvals, and competition from newer agents with potential efficacy advantages.

5. What strategic moves could expand AURYXIA’s market share?
Regulatory approval for additional indications, reimbursement negotiations, and development of combination therapies could enhance adoption.

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[1] Drug Enforcement Administration. (2023). AURYXIA (ferric citrate) prescribing information. U.S. Food and Drug Administration.