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Last Updated: April 30, 2025

CLINICAL TRIALS PROFILE FOR FERRIC CARBOXYMALTOSE


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All Clinical Trials for Ferric Carboxymaltose

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00548691 ↗ Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients Completed American Regent, Inc. Phase 3 2007-10-01 The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
NCT00548691 ↗ Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients Completed Luitpold Pharmaceuticals Phase 3 2007-10-01 The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
NCT00548860 ↗ Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients Completed American Regent, Inc. Phase 3 2007-10-01 The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
NCT00548860 ↗ Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients Completed Luitpold Pharmaceuticals Phase 3 2007-10-01 The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ferric Carboxymaltose

Condition Name

Condition Name for Ferric Carboxymaltose
Intervention Trials
Iron Deficiency Anemia 24
Anemia 23
Iron Deficiency 18
Iron-deficiency 14
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Condition MeSH

Condition MeSH for Ferric Carboxymaltose
Intervention Trials
Anemia, Iron-Deficiency 86
Anemia 65
Deficiency Diseases 20
Heart Failure 19
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Clinical Trial Locations for Ferric Carboxymaltose

Trials by Country

Trials by Country for Ferric Carboxymaltose
Location Trials
United States 147
Germany 24
Poland 16
Spain 15
Canada 10
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Trials by US State

Trials by US State for Ferric Carboxymaltose
Location Trials
Pennsylvania 13
Florida 10
Texas 9
California 8
New York 6
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Clinical Trial Progress for Ferric Carboxymaltose

Clinical Trial Phase

Clinical Trial Phase for Ferric Carboxymaltose
Clinical Trial Phase Trials
Phase 4 52
Phase 3 45
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Ferric Carboxymaltose
Clinical Trial Phase Trials
Completed 56
Recruiting 26
Not yet recruiting 16
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Clinical Trial Sponsors for Ferric Carboxymaltose

Sponsor Name

Sponsor Name for Ferric Carboxymaltose
Sponsor Trials
Vifor Pharma 24
American Regent, Inc. 21
Luitpold Pharmaceuticals 19
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Sponsor Type

Sponsor Type for Ferric Carboxymaltose
Sponsor Trials
Other 147
Industry 108
NIH 1
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Ferric Carboxymaltose: Clinical Trials, Market Analysis, and Projections

Introduction to Ferric Carboxymaltose

Ferric carboxymaltose (FCM) is an intravenous iron formulation that has gained significant attention in recent years for its efficacy in treating iron deficiency anemia, particularly in patients with chronic conditions such as heart failure and chronic kidney disease. Here, we will delve into the latest clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

HEART-FID Trial

One of the most notable clinical trials involving FCM is the HEART-FID trial. This randomized, double-blind, parallel trial aimed to evaluate the efficacy of intravenous ferric carboxymaltose in ambulatory patients with chronic systolic heart failure and iron deficiency. The trial enrolled 3,065 patients, with 1,532 receiving FCM and 1,533 receiving a placebo, in addition to their usual heart failure therapy.

  • Primary Outcomes: The trial showed a marginal improvement in the primary hierarchical composite outcome, which included death, hospitalization for heart failure, and 6-minute walk distance, with a p-value of 0.019. Although this did not meet the prespecified significance level of 0.01, it still indicated a positive trend[1][4].

  • Secondary Outcomes: The trial also reported a reduction in all-cause mortality (8.6% vs. 10.3%) and heart failure hospitalizations (13.3% vs. 14.8%) in the FCM group compared to the placebo group. There was a modest improvement in the 6-minute walk distance as well[1].

AFFIRM-AHF Trial

The AFFIRM-AHF trial further supported the benefits of FCM in patients with heart failure. This trial indicated a potential reduction in heart failure hospitalizations associated with FCM treatment. The combined analysis of HEART-FID, AFFIRM-AHF, and CONFIRM-HF trials suggested that FCM can reduce heart failure and cardiovascular-related hospitalizations, improving quality of life and exercise capacity for patients[4].

Market Analysis

Market Size and Growth

The Ferric Carboxymaltose Injection Market is projected to experience significant growth. As of 2023, the market size was valued at USD 16 billion and is expected to reach USD 30.9 billion by 2031, growing at a CAGR of 9.2% during the forecast period 2024-2031[2].

Market Segmentation

The market is segmented geographically, with North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa being key regions. North America, led by the U.S. and Canada, is characterized by a high prevalence of iron deficiency anemia and robust healthcare infrastructure, driving market growth. Europe, particularly countries like Germany, France, and the UK, also shows steady growth due to increasing awareness of anemia management and supportive healthcare policies[2].

Competitive Landscape

The intravenous iron drugs market, led by FCM, is highly competitive. FCM holds about 50% of the market revenue share due to its high performance, cost-effectiveness, and low risk of anaphylactic reactions. However, the market faces intense competition from other intravenous iron therapies, leading to price wars and reduced margins for manufacturers[5].

Regulatory Challenges

The Ferric Carboxymaltose Injection Market faces significant regulatory challenges. Stringent approval processes by health authorities such as the FDA and EMA require extensive clinical trials and documentation, leading to delays in product launches and increased development costs. Varying regulations across different countries further complicate the global marketing strategy[2].

Patient Awareness and Acceptance

Patient awareness and acceptance play a crucial role in the market growth of FCM. Increasing awareness of anemia management, particularly in regions like Europe and North America, has driven the demand for FCM. However, varying levels of healthcare access and economic conditions in regions like the Middle East and Africa affect market dynamics[2].

Clinical Benefits and Safety Profile

FCM has been shown to improve hemoglobin levels, reduce fatigue symptoms, and enhance physical function and global health in patients. It is particularly beneficial for patients with iron deficiency anemia who do not respond to oral iron preparations. The safety profile of FCM is consistent with previous reports, showing no new safety concerns and a very low risk of anaphylactic reactions[4].

Expert Insights

According to Robert Mentz, MD, lead author of the HEART-FID trial, "Putting this all together, I think we have convincing evidence that ferric carboxymaltose helps patients feel and function better and then there is a suggestion of potential reduction in mortality and hospitalizations." This underscores the clinical utility of FCM in managing heart failure and iron deficiency[4].

Projections and Future Outlook

The intravenous iron drugs market, led by FCM, is expected to continue growing due to several factors:

  • Increasing Prevalence of Anemia: The rising incidence of anemia, particularly in chronic conditions like heart failure and chronic kidney disease, will drive the demand for FCM.
  • Expanding Healthcare Access: Improvements in healthcare infrastructure and access, especially in emerging markets, will contribute to market growth.
  • Regulatory Approvals: Continued regulatory approvals and favorable healthcare policies will support the market expansion of FCM[2][3].

Key Takeaways

  • Clinical Efficacy: FCM has shown marginal improvements in cardiovascular outcomes in patients with heart failure and iron deficiency.
  • Market Growth: The FCM market is projected to reach USD 30.9 billion by 2031, growing at a CAGR of 9.2%.
  • Regulatory Challenges: The market faces significant regulatory hurdles, including stringent approval processes and varying regulations across regions.
  • Clinical Benefits: FCM improves hemoglobin levels, reduces fatigue, and enhances physical function with a low risk of anaphylactic reactions.
  • Geographical Dynamics: North America and Europe are key drivers of market growth, while the Asia-Pacific region presents emerging opportunities.

FAQs

Q: What is the primary use of ferric carboxymaltose?

A: Ferric carboxymaltose is primarily used to treat iron deficiency anemia, particularly in patients with chronic conditions such as heart failure and chronic kidney disease.

Q: What were the key findings of the HEART-FID trial?

A: The HEART-FID trial showed a marginal improvement in cardiovascular outcomes, including a reduction in all-cause mortality and heart failure hospitalizations, and an improvement in the 6-minute walk distance.

Q: How is the market for ferric carboxymaltose projected to grow?

A: The market is projected to reach USD 30.9 billion by 2031, growing at a CAGR of 9.2% during the forecast period 2024-2031.

Q: What are the main regulatory challenges facing the ferric carboxymaltose market?

A: The market faces stringent approval processes, varying regulations across regions, and the need for extensive clinical trials and documentation.

Q: What is the safety profile of ferric carboxymaltose?

A: FCM has a consistent safety profile with no new safety concerns and a very low risk of anaphylactic reactions.

References

  1. Ferric Carboxymaltose in Heart Failure With Iron Deficiency - HEART-FID. American College of Cardiology.
  2. Ferric Carboxymaltose Injection Market Size, Trends & Forecast. Verified Market Research.
  3. Intravenous Iron Drugs Market Size, Share, Trends & Forecast 2028. Polaris Market Research.
  4. Since FDA Approval, Several Studies Highlight Benefits of IV Ferric Carboxymaltose. The American Journal of Managed Care.
  5. Ferric Carboxymaltose in High Demand | Leading the Intravenous Iron Drugs Market Revenue. PharmiWeb.

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