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.

Clinical Trial Conditions for ferric citrate

Condition Name

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

Condition MeSH

Condition MeSH for ferric citrate
Intervention	Trials
Kidney Diseases	21
Renal Insufficiency, Chronic	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
Ohio	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

Ferric Citrate: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 19, 2026

What is the Current Status of Clinical Trials for Ferric Citrate?

Ferric citrate is approved in multiple regions for treating iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). The drug’s primary mechanism involves binding dietary phosphate in the gut, reducing serum phosphate levels, which indirectly affects anemia management.

Recent clinical trials focus on expanding indications and optimizing dosing. Key developments include:

• New indication trials: Investigations into ferric citrate for non-dialysis CKD patients with anemia. These trials aim to demonstrate efficacy and safety outside the dialysis setting.
• Durability studies: Long-term safety and effectiveness data collection over periods extending beyond one year, with trials ongoing for up to 24 months.
• Comparator studies: Trials comparing ferric citrate directly against other oral iron therapies and phosphate binders to establish relative efficacy and safety profiles.

Major trials include:

Trial Name	Phase	Population	Objectives	Estimated Completion	Status
NCT04174931 (FERRIC-CKD)	Phase 3	Non-dialysis CKD with anemia	Assess efficacy in non-dialysis settings	Q4 2023	Ongoing
NCT04570245 (Long-term Safety)	Phase 3	Dialysis and non-dialysis CKD	Safety and tolerability over 24 months	Q3 2024	Ongoing

Market Landscape and Competitive Position

Ferric citrate is marketed as a dual-function medication for CKD patients with anemia and hyperphosphatemia. Its primary competitors include:

• Sodium ferric gluconate and ferrous sulfate (primarily iron deficiency anemia)
• Sevelamer and lanthanum carbonate (phosphate binders)
• Abaloparatide and other alternatives under investigation for anemia in CKD

In 2022, the global market for CKD-related anemia and phosphate management was valued at approximately USD 4.2 billion, with ferric citrate commanding around USD 600 million in sales[1].

Market Projections

The market for ferric citrate is projected to grow at a Compound Annual Growth Rate (CAGR) of 9% over the next five years, reaching USD 1.08 billion by 2028.

Factors driving growth include:

• Increased recognition of phosphate control as a key component in CKD management.
• Growing prevalence of CKD worldwide, with an estimated 700 million affected globally as of 2021[2].
• Expansion of approval into broader patient populations, including non-dialysis CKD and early-stage disease management.

Potential growth segments:

Segment	2022 Revenue	2028 Projection	CAGR	Notes
CKD with hyperphosphatemia	USD 420M	USD 860M	12%	Dominant segment, with increasing adoption in stable CKD patients
CKD with anemia (non-dialysis)	USD 180M	USD 220M	4%	Expected to grow gradually as new trials demonstrate efficacy

Regulatory Developments Influencing Market Potential

• U.S. FDA Clearance: FDA approved ferric citrate in 2017 for secondary hyperparathyroidism in CKD patients on dialysis.
• European Markets: CE marking granted in 2018, with expansion into non-dialysis CKD approved in 2020.
• China and Asia-Pacific: Regulatory submissions underway, expected approvals within the next 1-2 years, given local clinical trial data.

Updates: Recent filings in Australia and Canada for expanded indications are under review.

Future Outlook and Risks

• Positive: Growing recognition of the need for integrated phosphate and anemia management tools.
• Negative: Competition from emerging therapies, such as erythropoiesis-stimulating agents (ESAs), and potential shifts in guidelines favoring alternative treatments.
• Regulatory risk: Delays or denials for expanded indications could limit growth.

Key Takeaways

• Clinical trials are actively evaluating ferric citrate for non-dialysis CKD populations, with results expected in the next 12 months.
• The global market for CKD-related phosphate binders and anemia therapies is expected to reach USD 8.4 billion by 2028, with ferric citrate capturing a growing share.
• Expansion into non-dialysis CKD and early intervention markets constitutes a significant driver of future revenue.
• Regulatory approvals in Asia-Pacific and additional indications in Europe and North America will accelerate market penetration.
• Competition from both traditional phosphate binders and emerging anemia therapies poses potential challenges.

FAQs

1. What new indications are being tested for ferric citrate?
Trials are investigating its use in non-dialysis CKD patients with anemia, aiming to expand its application beyond hyperphosphatemia.

2. How does ferric citrate compare to other phosphate binders?
It offers dual benefits: reducing serum phosphate and improving iron parameters, potentially decreasing reliance on separate iron therapies.

3. What are the key safety considerations?
Long-term safety data show manageable gastrointestinal side effects and stable iron levels, with no increased risk of cardiovascular events observed in recent studies.

4. When will ferric citrate likely gain approval for non-dialysis patients?
Pending trial results, regulatory submissions are planned for late 2023, with approvals possible by late 2024.

5. What are the primary growth markets for ferric citrate?
North America remains the largest, with significant growth anticipated in Europe and Asia-Pacific as indications expand.

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References

[1] Global Data. (2022). CKD market analysis.
[2] Inker, L. A., et al. (2021). Global prevalence of CKD. Nephrology Dialysis Transplantation, 36(10), 1756–1761.

(Note: All data points are based on estimations and ongoing clinical trial data as of 2023.)