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.
NCT00113685 ↗	Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2003-04-01	The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.

Clinical Trial Conditions for IRON DEXTRAN

Condition Name

Condition Name for IRON DEXTRAN
Intervention	Trials
Iron Deficiency Anemia	8
Keratoconus	4
Melanoma	3
HIV Infections	3

Condition MeSH

Condition MeSH for IRON DEXTRAN
Intervention	Trials
Anemia, Iron-Deficiency	16
Anemia	10
Deficiency Diseases	5
Diabetes Mellitus	4

Clinical Trial Locations for IRON DEXTRAN

Trials by Country

Trials by Country for IRON DEXTRAN
Location	Trials
United States	75
Sweden	5
Canada	5
Denmark	3
Nigeria	3

Trials by US State

Trials by US State for IRON DEXTRAN
Location	Trials
Maryland	9
Pennsylvania	8
California	6
Ohio	4
Texas	4

Clinical Trial Progress for IRON DEXTRAN

Clinical Trial Phase

Clinical Trial Phase for IRON DEXTRAN
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	17
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for IRON DEXTRAN
Clinical Trial Phase	Trials
Completed	33
Not yet recruiting	8
Recruiting	6

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	66
Industry	26
NIH	16

IRON DEXTRAN Market Analysis and Financial Projection

Iron Dextran: Clinical Trials, Market Analysis, and Projections

Introduction

Iron dextran is a widely used intravenous iron formulation for treating iron deficiency and iron deficiency anemia. This article delves into the current clinical trials, market analysis, and future projections for iron dextran, highlighting its benefits, challenges, and market trends.

Clinical Trials and Safety Considerations

Administration Protocol

The administration of iron dextran is critical and must be done under controlled conditions. This involves starting an intravenous line with a preferred 20-gauge catheter or larger, using normal saline as the intravenous solution, and avoiding dextrose and water due to higher adverse reaction rates[1].

Test Dose and Monitoring

A "test dose" method is often employed to minimize the risk of severe reactions. This involves introducing a miniscule dose of iron dextran into the drip chamber before gradually adding more, allowing for early detection and management of any adverse reactions[1].

Adverse Events

Clinical trials and studies have shown that while adverse events can occur, they are relatively rare. A cohort study evaluating infusion reactions among different IV iron formulations found that iron dextran had a 3.8% incidence of adverse events, with severe reactions being exceedingly rare[4].

Market Analysis

Global Market Size and Growth

The global intravenous iron drugs market, which includes iron dextran, is expected to grow significantly. In 2023, the market was valued at approximately $3.24 billion and is projected to reach $7.41 billion by 2033, growing at a CAGR of 8.62% from 2024 to 2033[2].

Market Trends and Drivers

Several factors are driving the growth of the IV iron drugs market, including:

• Rise in Incidence/Prevalence of Iron Deficiency: Increasing cases of iron deficiency and iron deficiency anemia are driving the demand for effective treatments[3].
• High Demand for Dextran-free Iron Therapeutics: Despite the historical use of iron dextran, there is a growing preference for dextran-free iron formulations due to their better safety profiles[3].
• Growing Demand Among Kidney Disease Patients: Patients with chronic kidney disease (CKD) and those undergoing dialysis are significant contributors to the demand for IV iron drugs[3].

Market Restraints and Safety Concerns

Side Effects and Safety Concerns

Iron dextran is associated with a higher risk of anaphylactic reactions compared to other IV iron formulations. This has led to a shift towards dextran-free alternatives, which are perceived as safer[3].

Comparative Safety

Studies have shown that iron dextran has a higher incidence of adverse events compared to other formulations like ferumoxytol and ferric carboxymaltose. For instance, a study found that iron sucrose and iron dextran had higher reaction rates compared to ferumoxytol and ferric carboxymaltose[4].

Market Projections and Future Outlook

Market Size Projections

The global IV and oral iron drugs market is expected to grow at a CAGR of approximately 13.47% from 2023 to 2029, reaching $16.34 billion by 2029[3].

Geographic Market Share

North America holds a significant share of the intravenous iron drugs market, with a 52% market share in 2023. The market is expected to grow further with the launch of new branded IV iron drugs and expanded indication approvals[2].

Innovations and New Product Launches

Key vendors such as Vifor Pharma Group, Daiichi Sankyo Group, and AMAG Pharmaceuticals are focusing on the development and launch of innovative iron therapeutics. These new products and expanded indications are expected to drive market growth and increase market share[3].

Key Takeaways

• Clinical Trials: Iron dextran administration requires careful monitoring and a test dose to mitigate adverse reactions.
• Market Growth: The global IV iron drugs market is expected to grow significantly, driven by increasing incidence of iron deficiency and demand for safer alternatives.
• Safety Concerns: Iron dextran is associated with higher risks of anaphylactic reactions, leading to a preference for dextran-free formulations.
• Market Projections: The market is projected to reach $7.41 billion by 2033 and $16.34 billion by 2029, driven by new product launches and expanded indications.

FAQs

What is the recommended administration protocol for iron dextran?

The administration of iron dextran should be done under controlled conditions using normal saline, with a test dose to monitor for adverse reactions. An intravenous line with a 20-gauge catheter or larger is preferred[1].

What are the common adverse events associated with iron dextran?

Adverse events include infusion reactions, with a 3.8% incidence rate. Severe reactions are rare but can include anaphylaxis, necessitating the availability of resuscitative equipment and medication like epinephrine[1][4].

Why is there a growing demand for dextran-free iron therapeutics?

Dextran-free iron formulations have better safety profiles compared to traditional iron dextran, reducing the risk of anaphylactic reactions and other adverse events[3].

What is the projected market size for the global IV iron drugs market by 2033?

The global IV iron drugs market is expected to reach around $7.41 billion by 2033, growing at a CAGR of 8.62% from 2024 to 2033[2].

Which regions dominate the intravenous iron drugs market?

North America holds a significant share of the market, with a 52% market share in 2023. The market is also growing in other regions with the launch of new branded IV iron drugs and expanded indication approvals[2].

Sources

1. MedStar Health - IV Iron Dextran Infusion Protocol
2. Biospace - Intravenous Iron Drugs Market Size to Worth Around US$ 7.41 Billion by 2033
3. Arizton - IV and Oral Iron Drugs Market Report | Size, Share and Growth
4. JAMA Network - Analysis of Adverse Events and Intravenous Iron Infusion
5. 360iResearch - Iron Drugs Market by Product, Application - Global Forecast 2025