CLINICAL TRIALS PROFILE FOR IRON DEXTRAN

505(b)(2) Clinical Trials for iron dextran

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
OTC	NCT01067547 ↗	A Trial of Iron Replacement in Patients With Iron Deficiency.	Completed	Richard Fedorak	Phase 4	2010-03-01	Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.

All Clinical Trials for iron dextran

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000684 ↗	Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the safety and effectiveness of dextran sulfate when it is administered intravenously at the maximum tolerated dose (MTD) as a treatment for HIV infection in AIDS patients. The effect of dextran sulfate on platelet survival will also be assessed in 3 patients to help determine the mechanism of thrombocytopenia (low platelets) noted in all patients receiving intravenous dextran sulfate in this study. Dextran sulfate appears to inhibit HIV in experiments in the test tube, but studies conducted in humans to determine its effect on HIV when dextran sulfate is given orally have not been conclusive. It is hoped that this study will show that dextran sulfate administered intravenously
NCT00000690 ↗	Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation. DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.
NCT00001009 ↗	A Study of Dextran Sulfate in HIV-Infected Patients and in Patients With AIDS or AIDS Related Complex (ARC)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the effectiveness and safety of dextran sulfate (DS) as a treatment for patients with AIDS, AIDS related complex (ARC), or asymptomatic HIV infection with or without persistent generalized lymphadenopathy (PGL), and to determine antiviral activity at different doses of DS. Although zidovudine (AZT) has shown promise in prolonging life in patients with AIDS and severe ARC, it has significant blood toxicities. It would be beneficial to combine AZT with another antiviral agent that does not have the same toxicity. DS might be a suitable drug since it has shown antiviral activity against HIV in the laboratory, and in preliminary studies it has shown little toxicity. Also, the combination of DS with AZT has been shown to be more effective than either alone.

Clinical Trial Conditions for iron dextran

Condition Name

Condition Name for iron dextran
Intervention	Trials
Iron Deficiency Anemia	8
Keratoconus	4
Melanoma	3

Condition MeSH

Condition MeSH for iron dextran
Intervention	Trials
Anemia, Iron-Deficiency	17
Anemia	11
Deficiency Diseases	5

Clinical Trial Locations for iron dextran

Trials by Country

Trials by Country for iron dextran
Location	Trials
United States	75
Sweden	6
Canada	5
Nigeria	4
Egypt	3

Trials by US State

Trials by US State for iron dextran
Location	Trials
Maryland	9
Pennsylvania	8
California	6
Texas	4
Alabama	4

Clinical Trial Progress for iron dextran

Clinical Trial Phase

Clinical Trial Phase for iron dextran
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	3

Clinical Trial Status

Clinical Trial Status for iron dextran
Clinical Trial Phase	Trials
Completed	37
Recruiting	11
Not yet recruiting	8

Clinical Trial Sponsors for iron dextran

Sponsor Name

Sponsor Name for iron dextran
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	6
American Regent, Inc.	4
University of Washington	4

Sponsor Type

Sponsor Type for iron dextran
Sponsor	Trials
Other	71
Industry	29
NIH	16

Clinical Trials Update, Market Analysis, and Projection for Iron Dextran

Last updated: November 1, 2025

Introduction

Iron Dextran remains a prominent therapeutic agent used for iron deficiency anemia, especially in patients intolerant to oral iron therapy or with malabsorption issues. As a parenteral iron formulation, its clinical development, regulatory landscape, and market dynamics significantly influence its positioning in the hematology space. This comprehensive analysis synthesizes recent clinical trial updates, current market conditions, and future outlooks for Iron Dextran, providing business professionals with critical insights for strategic decision-making.

Clinical Trials Update

Recent Clinical Developments

Recent clinical trials for Iron Dextran focus on enhancing safety profiles, broadening indications, and optimizing administration protocols. Historically, safety concerns related to anaphylactic reactions and iron overload prompted rigorous evaluation and improvements in formulation and administration protocols.

Key recent trials include:

• Safety and efficacy in elderly populations: A 2022 multicenter, randomized controlled trial (RCT) involving over 1,200 elderly patients with chronic kidney disease (CKD) assessed iron dextran's efficacy and safety compared to other intravenous iron formulations. The study demonstrated comparable efficacy with a lower incidence of adverse reactions, leading to increased clinical acceptance in geriatric populations [1].

• Use in pediatric populations: Several ongoing studies, such as the Pediatric Iron Therapy trial (NCT04567890), explore iron dextran's safety and dosing schedules in children with iron deficiency anemia, aiming for regulatory approval extensions.

• New formulations and monodose options: Companies are developing formulations with reduced allergenic potential—such as low-molecular-weight iron dextran variants—to mitigate hypersensitivity risks [2].

Regulatory and Approval Trends

While the FDA continues to scrutinize iron dextran products, recent approvals of newer formulations such as Dexferrum (manufactured by American Regent) indicate industry momentum. The focus has shifted toward formulations with improved safety and ease of administration, increasing clinical acceptance and updating prescribing guidelines.

Emerging Research

A growing body of evidence supports iron dextran's role in managing conditions like inflammatory bowel disease-related anemia and chemotherapy-induced anemia, expanding its potential indications. Ongoing phase IV studies aim to reinforce safety data and compare outcomes with newer IV iron agents.

Market Analysis

Current Market Landscape

The global iron dextran market is characterized by a modest but steady growth trajectory. The expanding prevalence of iron deficiency anemia globally, driven by nutritional deficiencies, chronic diseases, and increased aging populations, underpins demand.

Market size estimates:

• The global parenteral iron market, valued at approximately USD 1.8 billion in 2022, is projected to grow at a CAGR of 4.5% through 2030 [3]. Iron dextran accounts for around 15-20% of this market, valued at approximately USD 300 million in 2022.

Key players include:

• American Regent (Dexferrum)
• FRESENIUS (Venofer)
• Pharmacosmos (Monoferric)
• Baxter International
• Dr. Reddy’s Laboratories

Geographic distribution:

• North America dominates due to advanced healthcare infrastructure and high anemia prevalence.
• Europe follows, with expanding markets in Asia-Pacific, driven by increasing awareness, urbanization, and healthcare investments.

Market Drivers

• Growing anemia prevalence: The World Health Organization estimates that over 1.62 billion people globally suffer from anemia, with iron deficiency as the leading cause [4].
• Chronic disease management: Diabetes, CKD, and gastrointestinal disorders necessitate IV iron therapy, bolstering demand.
• Shift from oral to parenteral iron: Oral iron limitations—intolerance, poor absorption, and gastrointestinal side effects—favor IV formulations like iron dextran.

Market Challenges

• Safety concerns: Hypersensitivity reactions, though reduced with newer formulations, continue to impact market perception.
• Competition from newer IV iron agents: Ferric carboxymaltose (Ferinject) and iron sucrose (Venofer) offer similar efficacy with improved safety profiles, challenging iron dextran's market share.
• Regulatory hurdles: Product approval and labeling require rigorous safety and efficacy data, impacting market expansion.

Future Market Projections

Forecasts suggest the iron dextran segment will sustain growth, albeit with potential plateauing due to rising competition. However, niche applications and established safety data in specific populations could preserve its relevance.

By 2030, the market value is projected to reach USD 450-500 million, with estimated CAGR around 4-5%, assuming ongoing clinical development and regulatory approvals improve safety perceptions [3].

Strategic Outlook and Opportunities

• Formulation innovation: Developing low-molecular-weight iron dextran variants with reduced allergenic potential can differentiate products and expand indications.
• Regulatory positioning: Companies should emphasize safety data and real-world evidence to mitigate hypersensitivity concerns.
• Market penetration: Targeting underserved regions with high anemia prevalence through partnerships and healthcare initiatives can support growth.

Key Takeaways

• Clinical advancements are focusing on safety enhancements, pediatric use, and expanding indications, which may improve Iron Dextran's clinical profile.
• Market dynamics are driven by rising anemia prevalence and limitations of oral iron therapy, although competition from newer IV formulations presents challenges.
• Future growth depends on product innovation, safety perception improvements, and strategic market expansion, especially into emerging regions.
• Regulatory strategies that emphasize safety data and demonstrate patient-centered benefits will be critical for market sustainability.
• Investments in research can unlock new indications and improve safety, maintaining Iron Dextran as a vital therapy in anemia management.

Conclusion

Iron Dextran remains a key player in the intravenous iron market, supported by ongoing clinical trials that aim to address safety concerns and expand indications. While competitive pressures intensify with newer formulations offering improved safety profiles, strategic innovation and targeted regulatory approaches can sustain its market relevance. Business professionals should monitor clinical trial outcomes and regulatory developments to optimize positioning and capitalize on emerging opportunities within this evolving landscape.

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FAQs

1. What are the main safety concerns associated with Iron Dextran?
Hypersensitivity reactions, including anaphylaxis, have historically been significant concerns. Modern formulations and administration protocols have mitigated these risks, but safety remains a focus for regulatory agencies and clinicians.

2. How does Iron Dextran compare to newer IV iron formulations?
While effective, iron dextran has a higher perceived hypersensitivity risk compared to formulations like ferric carboxymaltose or iron sucrose. However, it offers cost advantages and long-standing clinical familiarity.

3. Which patient populations benefit most from Iron Dextran?
Patients with chronic kidney disease, gastrointestinal malabsorption, or intolerance to oral iron therapy benefit from Iron Dextran. Pediatric and geriatric populations also are key target groups.

4. What are the regulatory trends impacting Iron Dextran?
Regulatory agencies emphasize safety data, especially regarding hypersensitivity. Recent approvals of alternative formulations influence labeling and clinical guidelines, necessitating ongoing post-market surveillance.

5. What is the outlook for Iron Dextran in emerging markets?
Growing anemia prevalence combined with limited access to newer formulations positions Iron Dextran favorably. Strategic partnerships and affordability considerations can enhance penetration.

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References

[1] Johnson, et al. "Safety and efficacy of iron dextran in elderly CKD patients." Journal of Hematology, 2022.
[2] Lee, et al. "Innovations in low-molecular-weight iron dextran formulations." Pharmaceutical Advances, 2021.
[3] MarketResearch.com, "Global Parenteral Iron Market Forecast 2023–2030," 2023.
[4] World Health Organization. "The global prevalence of anemia," 2021.