CLINICAL TRIALS PROFILE FOR FERRIC CITRATE

505(b)(2) Clinical Trials for ferric citrate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00967993 ↗	Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease	Completed	Keryx Biopharmaceuticals		2010-01-01	The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).

All Clinical Trials for ferric citrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00648167 ↗	A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)	Completed	Collaborative Study Group (CSG)	Phase 2	2008-03-01	This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
NCT00648167 ↗	A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)	Completed	Keryx Biopharmaceuticals	Phase 2	2008-03-01	This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
NCT00967993 ↗	Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease	Completed	Keryx Biopharmaceuticals		2010-01-01	The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).
NCT01074125 ↗	A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease	Completed	Collaborative Study Group (CSG)	Phase 3	2010-05-01	This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
NCT01074125 ↗	A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease	Completed	Keryx Biopharmaceuticals	Phase 3	2010-05-01	This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
NCT01191255 ↗	A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis	Completed	Keryx Biopharmaceuticals	Phase 3	2010-10-01	This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
NCT01503736 ↗	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease	Completed	Panion & BF Biotech Inc.	Phase 3	2010-06-01	The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).

Clinical Trial Conditions for ferric citrate

Condition Name

Condition Name for ferric citrate
Intervention	Trials
Hyperphosphatemia	15
End Stage Renal Disease	11
End-Stage Renal Disease	4
ESRD	4

Condition MeSH

Condition MeSH for ferric citrate
Intervention	Trials
Renal Insufficiency, Chronic	21
Kidney Diseases	21
Kidney Failure, Chronic	16
Hyperphosphatemia	16

Clinical Trial Locations for ferric citrate

Trials by Country

Trials by Country for ferric citrate
Location	Trials
United States	159
Puerto Rico	4
Israel	3
Taiwan	3
China	2

Trials by US State

Trials by US State for ferric citrate
Location	Trials
Texas	12
California	11
Florida	10
Georgia	8
Michigan	7

Clinical Trial Progress for ferric citrate

Clinical Trial Phase

Clinical Trial Phase for ferric citrate
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	13
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ferric citrate
Clinical Trial Phase	Trials
Completed	22
Not yet recruiting	5
Recruiting	4

Clinical Trial Sponsors for ferric citrate

Sponsor Name

Sponsor Name for ferric citrate
Sponsor	Trials
Keryx Biopharmaceuticals	15
Rockwell Medical Technologies, Inc.	9
Panion & BF Biotech Inc.	4

Sponsor Type

Sponsor Type for ferric citrate
Sponsor	Trials
Industry	31
Other	12
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Ferric Citrate

Last updated: October 28, 2025

Introduction

Ferric Citrate, marketed notably as Auryxia® (FDA-approved) and Riona® in some regions, is an oral iron-based phosphate binder primarily approved for managing hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis and iron deficiency anemia in non-dialysis-dependent CKD. Its unique mechanism of delivering bioavailable iron while binding dietary phosphate positions it as a multifaceted therapeutic agent. This article offers an authoritative overview of recent clinical trial developments, comprehensive market analysis, and strategic projections, providing stakeholders with critical insights into Ferric Citrate’s evolving landscape.

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Clinical Trials Update

Current and Recent Clinical Studies

Ferric Citrate's clinical development has been marked by rigorous trials evaluating its efficacy, safety, and broader potential applications. The key recent developments include:

• Phase 3 Trials for Iron-Deficiency Anemia (IDA) in Non-Dialysis CKD:
  Completed in 2021, these trials demonstrated that Ferric Citrate effectively increases hemoglobin levels and iron stores without significantly elevating the risk of iron overload or cardiovascular events. Outcomes showed that patients on Ferric Citrate exhibited:

  • Significant improvements in hemoglobin and ferritin levels compared to placebo.
  • Reduced dependence on injectable erythropoiesis-stimulating agents (ESAs).
  • Minimal adverse effects, primarily mild gastrointestinal discomfort.

• Hyperphosphatemia Management in CKD Patients on Dialysis:
  Continued post-marketing surveillance and observational studies affirm its phosphate-lowering capabilities. Recently, a multicenter trial published in Nephrology Dialysis Transplantation (2022) confirmed sustained phosphate control over 12 months, with a favorable safety profile.

Upcoming and Ongoing Trials

• Phase 4 Post-Marketing Studies:
  Targeting long-term safety and efficacy, these studies also explore potential benefits in non-traditional indications, such as anemia management in earlier CKD stages and instances of mineral and bone disorder (CKD-MBD).

• Exploratory Trials for Broader Use:
  Investigations into Ferric Citrate's role in iron deficiency in other chronic conditions, such as inflammatory bowel disease or heart failure, are underway, though these are in preliminary phases and lack definitive data.

Regulatory and Approval Adjustments

In line with accumulating evidence, regulatory agencies like the FDA and EMA continue to monitor post-market data, with no recent indications of major safety concerns or regulatory delays impacting Ferric Citrate’s approved indications.

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Market Analysis

Global Market Size and Growth Drivers

The global market for phosphate binders and iron therapies is expanding rapidly. In 2022, the dialysis and CKD management market was valued at approximately $10 billion, projected to grow at a compound annual growth rate (CAGR) of around 7% through 2028 [1].

Ferric Citrate benefits from:

• Shift toward oral therapies: Growing preference for oral phosphate binders over aluminum-based or calcium-based agents due to safety concerns.
• Rise in CKD prevalence: Over 850 million people globally live with CKD, according to the Global Burden of Disease Study 2017, fueling demand for effective phosphate and anemia management solutions [2].
• Healthcare financial pressures: Preference for cost-effective treatments that reduce hospitalization and IV therapy costs reinforces Ferric Citrate’s appeal.

Key Market Segments

• Dialysis-dependent CKD:
  Ferric Citrate's primary market, with a substantial portion of patients requiring phosphate management and anemia correction.

• Non-Dialysis CKD:
  An emerging segment as evidence supports its dual use for iron deficiency and phosphate control outside dialysis.

• Geographic Markets:
  North America remains the largest market, driven by extensive CKD prevalence, favorable reimbursement policies, and high awareness. Europe and Asia-Pacific represent growing opportunities, especially as aging populations and rising CKD incidence contribute to market expansion.

Competitive Landscape

Ferric Citrate faces competition from:

• Sevelamer (Renvela®): High-cost, non-iron-based phosphate binder.
• Lanthanum Carbonate (Fosrenol®): Oral, effective but less blood-compatible.
• Calcium-based binders: Cost-effective but associated with calcium overload risks.
• Intravenous iron and ESAs: Used in anemia correction but pose risks of adverse events and higher costs.

Ferric Citrate's advantages include oral administration, dual efficacy, and a favorable safety profile, positioning it as a preferred choice in many clinical settings.

Pricing and Reimbursement Trends

Pricing strategies vary by region but generally position Ferric Citrate as a mid-tier therapy, balancing cost-effectiveness and clinical benefits. Reimbursement remains robust in major markets, with Continued insurance coverage supported by clinical efficacy data, especially in the US where CMS (Centers for Medicare & Medicaid Services) has designated it as a standard therapy for certain CKD patients.

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Market Projections

Short-term Outlook (Next 2–3 Years)

• Continued adoption in North America driven by physician familiarity and positive post-marketing data.
• Expansion into non-dialysis CKD management, fueled by ongoing trials.
• Slight price stabilization amidst increased competition but maintained market share due to clinical advantages.

Medium to Long-term Outlook (3–10 Years)

• Market Penetration in Emerging Markets:
  Growing healthcare infrastructure and CKD awareness in Asia-Pacific and Latin America will drive adoption.

• Introduction of New Formulations:
  Fixed-dose combinations or formulations designed for easier administration could boost compliance and market share.

• Potential Off-label Uses:
  Pending trial successes, expanding indications could further propel growth, especially in iron deficiency anemia across broader patient populations.

• Regulatory Approvals:
  Expansion of indications, including earlier-stage CKD, could emerge from successful clinical trials.

• Market Share Growth:
  By 2030, Ferric Citrate could command nearly 15-20% of the global phosphate binder market and 10-15% of the iron deficiency anemia therapy segment, contingent on clinical trial success, pricing, and regional approvals.

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Key Takeaways

• Ferric Citrate benefits from compelling clinical evidence supporting its dual role in phosphate control and iron deficiency correction, with a favorable safety profile.
• The drug's market is expanding amid rising CKD prevalence, especially as clinicians prefer oral, cost-effective therapies.
• Current competitive pressures favor Ferric Citrate due to its unique mechanism and patient tolerability.
• Ongoing and future trials targeting broader indications and earlier CKD stages will be critical to sustaining growth.
• Strategic expansion in emerging markets and formulation innovation will be essential for maximizing long-term market share.

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FAQs

Q1: What are the primary advantages of Ferric Citrate over traditional phosphate binders?
A: Ferric Citrate is orally administered, offers dual benefits of phosphate binding and iron supplementation, reduces reliance on injectable therapies, and demonstrates a favorable safety profile compared to calcium-based binders and other alternatives.

Q2: Are there any notable safety concerns associated with Ferric Citrate?
A: Clinical data indicate that Ferric Citrate is generally well-tolerated. Mild gastrointestinal symptoms are the most common adverse events. No significant increase in iron overload or cardiovascular risks has been observed in recent studies.

Q3: What is the forecasted market opportunity for Ferric Citrate in non-dialysis CKD patients?
A: As evidence accumulates, non-dialysis CKD represents an emerging and sizeable segment. By 2030, it could constitute 20-25% of Ferric Citrate's target market, driven by clinical trial data confirming efficacy.

Q4: How might regulatory developments influence Ferric Citrate's market growth?
A: Expanded approvals for broader indications, earlier CKD stages, or new formulations could significantly increase its usage, particularly if clinical trials demonstrate substantial benefits.

Q5: What challenges does Ferric Citrate face in market expansion?
A: Competition from other phosphate binders and iron therapies, pricing pressures, regional regulatory hurdles, and physician adoption patterns could impact growth trajectories.

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References

1. MarketsandMarkets. "Nephrology Drugs Market by Product and Region — Global Forecast to 2028."
2. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. "Global, regional, and national burden of chronic kidney disease, 1990–2017." The Lancet, 2020.