You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: May 20, 2025

CLINICAL TRIALS PROFILE FOR FERRIC PYROPHOSPHATE CITRATE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Ferric Pyrophosphate Citrate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02595437 ↗ Triferic Pediatric Pharmacokinetic Protocol Completed Rockwell Medical Technologies, Inc. Phase 1/Phase 2 2015-11-01 The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.
NCT02636049 ↗ Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers Completed Rockwell Medical Technologies, Inc. Phase 1 2015-10-01 This is a Phase 1, open-label, three-period sequential dosing study being conducted to determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy adults.
NCT02739100 ↗ Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients Completed Rockwell Medical Technologies, Inc. Phase 1 2016-04-01 The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ferric Pyrophosphate Citrate

Condition Name

Condition Name for Ferric Pyrophosphate Citrate
Intervention Trials
End Stage Renal Disease 7
Iron-refractory, Iron-deficiency Anemia (IRIDA) 1
Peritoneal Dialysis (PD) 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Ferric Pyrophosphate Citrate
Intervention Trials
Kidney Failure, Chronic 7
Anemia, Iron-Deficiency 3
Kidney Diseases 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Ferric Pyrophosphate Citrate

Trials by Country

Trials by Country for Ferric Pyrophosphate Citrate
Location Trials
United States 21
Puerto Rico 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Ferric Pyrophosphate Citrate
Location Trials
Florida 5
California 2
Michigan 2
Texas 2
Ohio 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Ferric Pyrophosphate Citrate

Clinical Trial Phase

Clinical Trial Phase for Ferric Pyrophosphate Citrate
Clinical Trial Phase Trials
Phase 3 1
Phase 2 2
Phase 1/Phase 2 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Ferric Pyrophosphate Citrate
Clinical Trial Phase Trials
Completed 8
Recruiting 1
Terminated 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Ferric Pyrophosphate Citrate

Sponsor Name

Sponsor Name for Ferric Pyrophosphate Citrate
Sponsor Trials
Rockwell Medical Technologies, Inc. 11
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Ferric Pyrophosphate Citrate
Sponsor Trials
Industry 11
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

Introduction

Ferric pyrophosphate citrate, marketed under the name Triferic®, is a significant advancement in the treatment of iron deficiency and anemia, particularly in patients undergoing hemodialysis. This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

CRUISE 1 and CRUISE 2 Trials

The safety and efficacy of ferric pyrophosphate citrate were evaluated in two Phase 3, randomized, placebo-controlled clinical trials known as CRUISE 1 and CRUISE 2. These trials involved 599 iron-replete chronic hemodialysis patients who were dialyzed with either dialysate containing 2 µM ferric pyrophosphate citrate or standard dialysate (placebo) for up to 48 weeks. The primary efficacy endpoint was the change in hemoglobin concentration from baseline to the end of treatment[4].

Key Findings

  • The trials demonstrated that ferric pyrophosphate citrate maintained hemoglobin and iron balance in chronic hemodialysis patients without the need for additional oral or intravenous iron supplementation.
  • The drug showed a minimal impact on hemoglobin levels, with changes from baseline to the end of treatment being relatively stable compared to the placebo group[1][4].

Adverse Reactions

Clinical trials reported that hypersensitivity reactions were rare, occurring in only 1 (0.3%) of 292 patients receiving ferric pyrophosphate citrate. Other adverse reactions were generally mild and comparable to those in the placebo group[1].

Market Analysis

Market Size and Growth

The ferric pyrophosphate citrate market is part of the broader ferric pyrophosphate market, which was valued at USD 100 million in 2023 and is expected to reach USD 140.7 million by 2031, growing at a CAGR of 5.2% from 2024 to 2031. This growth is driven by increasing demand for iron-enriched products, particularly in the food and beverage sector, as well as in pharmaceuticals and nutritional supplements[2].

Segmentation

The market is segmented by type (food grade, industrial grade, pharmaceutical grade) and application (food fortification, iron supplements, water treatment, cosmetics). The pharmaceutical grade segment is particularly relevant for ferric pyrophosphate citrate, given its use in treating iron deficiency and anemia[2].

Driving Factors

  • Nutritional Awareness: Growing consumer awareness of nutritional benefits and health advantages is driving the demand for iron-enriched products.
  • Regulatory Support: Supportive regulatory frameworks encouraging iron fortification in food formulations are also contributing to market growth.
  • Technological Advancements: Improvements in food processing technologies enable the effective incorporation of ferric pyrophosphate without compromising the quality of the final product[2].

Market Projections

Pharmaceutical Industry Impact

The pharmaceutical industry is a significant driver of the ferric pyrophosphate citrate market. The drug's stability and bioavailability make it a preferred choice for treating iron deficiency and anemia in patients undergoing hemodialysis. Rockwell Medical, the company behind Triferic®, has seen financial growth and has expanded its supply agreements, indicating a strong market position[3].

Global Expansion

The market is expected to expand globally, particularly in regions where iron deficiency is prevalent. Developing nations, with their rising disposable incomes and shifting dietary habits, are driving up demand for fortified foods and nutritional supplements, further boosting the market[2].

Key Applications

Hemodialysis

Ferric pyrophosphate citrate is primarily used in hemodialysis to maintain iron balance and prevent anemia. Its administration via the dialysate allows for direct donation of iron to transferrin, bypassing the reticuloendothelial system and avoiding iron sequestration[4].

Food Fortification

Beyond its pharmaceutical use, ferric pyrophosphate citrate is also used in food fortification due to its stability and bioavailability. This application is crucial in addressing widespread iron deficiency, especially in regions where dietary iron intake is insufficient[2].

Regulatory and Safety Considerations

FDA Approval

Ferric pyrophosphate citrate has been approved by the FDA for use in hemodialysis patients. The approval was based on adequate and well-controlled studies that demonstrated its safety and efficacy[1].

Safety Profile

The safety profile of ferric pyrophosphate citrate is generally favorable, with minimal adverse reactions reported in clinical trials. However, as with any drug, monitoring for hypersensitivity reactions and other potential side effects is necessary[1].

Conclusion

Ferric pyrophosphate citrate is a critical drug in the management of iron deficiency and anemia, particularly in patients undergoing hemodialysis. The clinical trials have demonstrated its efficacy and safety, while market analysis indicates strong growth driven by increasing demand for iron-enriched products and supportive regulatory frameworks.

Key Takeaways

  • Clinical Efficacy: Ferric pyrophosphate citrate maintains hemoglobin and iron balance in chronic hemodialysis patients.
  • Market Growth: The market is expected to grow at a CAGR of 5.2% from 2024 to 2031, driven by nutritional awareness and regulatory support.
  • Pharmaceutical Impact: The drug is a significant player in the pharmaceutical industry, particularly in treating iron deficiency and anemia.
  • Global Expansion: The market is expanding globally, with a focus on regions with high prevalence of iron deficiency.

FAQs

What is ferric pyrophosphate citrate used for?

Ferric pyrophosphate citrate is used to maintain iron balance and prevent anemia in patients undergoing hemodialysis.

What were the key findings of the CRUISE 1 and CRUISE 2 trials?

The trials showed that ferric pyrophosphate citrate maintained hemoglobin and iron balance in chronic hemodialysis patients without the need for additional iron supplementation.

What is the projected market size for ferric pyrophosphate citrate by 2031?

The market is expected to reach USD 140.7 million by 2031, growing at a CAGR of 5.2% from 2024 to 2031.

What are the main drivers of the ferric pyrophosphate citrate market?

The main drivers include growing consumer awareness of nutritional benefits, supportive regulatory frameworks, and technological advancements in food processing.

Is ferric pyrophosphate citrate safe?

The drug has a generally favorable safety profile, with minimal adverse reactions reported in clinical trials, although monitoring for hypersensitivity reactions is necessary.

What other applications does ferric pyrophosphate citrate have besides hemodialysis?

It is also used in food fortification due to its stability and bioavailability, helping to address widespread iron deficiency.

Sources

  1. FDA Label: TRIFERIC AVNU® (ferric pyrophosphate citrate injection) Label.
  2. Market Research Intellect: Ferric Pyrophosphate Market Size, Growth & Analysis Report 2024.
  3. Rockwell Medical: First Quarter 2022 Financial and Operational Update.
  4. PubMed: Ferric pyrophosphate citrate (Triferic™) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients.
Last updated: 2025-01-01

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.