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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR IRON SUCROSE


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505(b)(2) Clinical Trials for Iron Sucrose

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 NCT00262145 ↗ Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption Completed NatureGen Phase 1 2005-10-01 Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of "tea" made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies.
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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Iron Sucrose

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00111956 ↗ Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome Completed Massachusetts General Hospital Phase 2/Phase 3 2004-04-01 Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗ Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2/Phase 3 2004-04-01 Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00125996 ↗ Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure Unknown status 4th Military Hospital Phase 1/Phase 2 2004-07-01 This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). The hypotheses are: - Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2. - IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Iron Sucrose

Condition Name

Condition Name for Iron Sucrose
Intervention Trials
Anemia 22
Pain 14
Iron Deficiency Anemia 13
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Condition MeSH

Condition MeSH for Iron Sucrose
Intervention Trials
Anemia, Iron-Deficiency 40
Anemia 38
Deficiency Diseases 17
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Clinical Trial Locations for Iron Sucrose

Trials by Country

Trials by Country for Iron Sucrose
Location Trials
United States 180
Canada 24
Spain 9
Germany 9
France 8
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Trials by US State

Trials by US State for Iron Sucrose
Location Trials
Pennsylvania 15
Florida 11
Maryland 10
Massachusetts 10
New York 8
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Clinical Trial Progress for Iron Sucrose

Clinical Trial Phase

Clinical Trial Phase for Iron Sucrose
Clinical Trial Phase Trials
Phase 4 37
Phase 3 41
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Iron Sucrose
Clinical Trial Phase Trials
Completed 87
Unknown status 19
Not yet recruiting 16
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Clinical Trial Sponsors for Iron Sucrose

Sponsor Name

Sponsor Name for Iron Sucrose
Sponsor Trials
American Regent, Inc. 12
Luitpold Pharmaceuticals 12
Pharmacosmos A/S 6
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Sponsor Type

Sponsor Type for Iron Sucrose
Sponsor Trials
Other 148
Industry 84
NIH 5
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Iron Sucrose: Clinical Trials, Market Analysis, and Projections

Introduction to Iron Sucrose

Iron sucrose, marketed under the trade name Venofer, is an intravenous iron preparation used to treat iron deficiency anemia, particularly in patients with chronic kidney disease (CKD) and those undergoing hemodialysis. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Overview of Clinical Studies

Clinical trials for Venofer have been extensive, focusing on its safety and efficacy in various patient populations. One notable study, Study 1VEN03017, was a randomized, open-label trial involving 145 patients aged 2 to 20 years with CKD on stable erythropoietin (EPO) therapy. The study compared the safety of three different Venofer maintenance dosing regimens over a 12-week period. The primary objective was to evaluate the safety, while the secondary endpoints included maintaining hemoglobin levels between 10.5 and 14 g/dL and transferrin saturation (TSAT) between 20% and 50% with stable EPO dosing[1].

Safety and Efficacy Outcomes

The clinical trials have shown that Venofer is effective in replenishing iron stores and maintaining hemoglobin levels within the target range. The safety profile of Venofer has been well-established, with the drug demonstrating a favorable safety record, especially when compared to other intravenous iron products. The studies have also highlighted the convenience of administration and the effectiveness of Venofer in patients who cannot absorb oral iron supplements effectively[1][3].

Regulatory Background

Venofer was initially approved by the FDA in 2000 and had been marketed in Europe for over 50 years prior to its U.S. approval. The drug has undergone several regulatory reviews and updates, including a supplement submitted for labeling updates and to address postmarket requirements and commitments[1].

Market Analysis

Market Size and Growth

The global market for Venofer (iron sucrose injection) is substantial and growing. As of 2023, the market size was estimated to be around $110 million and is forecasted to reach $174.9 million by 2030, growing at a CAGR of 5.9% during the forecast period of 2024-2030[4].

Market Segmentation

The market for Venofer is segmented based on application (adult and pediatric), types (50 mg/2.5 mL, 100 mg/5 mL, 200 mg/10 mL), and geography (North America, South America, Europe, Middle East & Africa, and Asia Pacific). North America and Europe are the dominant regions, with Luitpold Pharmaceuticals being a key player in this market[2][4].

Driving Forces

The growth of the Venofer market is driven by several factors, including:

  • Increasing Prevalence of Iron Deficiency Anemia: The rising number of patients with chronic diseases such as CKD, cancer, and inflammatory bowel disease is a significant driver.
  • Growing Demand for Safe and Effective Iron Replacement Therapies: The need for rapid replenishment of iron stores in patients who cannot absorb oral iron effectively is a key factor.
  • Increasing Awareness: Growing awareness among healthcare professionals and patients about the benefits of Venofer is also driving market growth[2][5].

Challenges and Restraints

Despite the growth, the market faces several challenges:

  • High Cost: Venofer is more expensive compared to some other iron replacement therapies.
  • Potential Side Effects: Although rare, side effects can be a concern.
  • Alternative Therapies: The availability of other intravenous iron products can act as a restraint[2].

Market Projections

Future Growth

The intravenous iron drugs market, which includes Venofer, is expected to experience significant growth. The global intravenous iron drugs market was valued at $2.95 billion in 2022 and is projected to grow to $6.1 billion by 2031, with a CAGR of 8.4%[3].

Regional Growth

North America and Europe are expected to continue dominating the market, but there is also significant growth anticipated in the Asia Pacific region. The U.S. market, in particular, is projected to reach $1 billion by 2032[5].

Emerging Trends

Several emerging trends are shaping the market:

  • Development of New Formulations: Innovations such as nanoparticle-based and liposome-encapsulated iron formulations are enhancing safety, efficacy, and convenience.
  • Combination Therapies: The growing use of Venofer in combination with other treatments for iron deficiency anemia.
  • Expanding Use in Developing Countries: Increasing access to Venofer in developing countries is another trend[5].

Key Takeaways

  • Clinical Efficacy: Venofer has demonstrated strong efficacy in clinical trials, particularly in maintaining hemoglobin levels and TSAT in patients with CKD.
  • Market Growth: The market for Venofer is projected to grow significantly, driven by the increasing prevalence of iron deficiency anemia and the growing demand for safe and effective iron replacement therapies.
  • Challenges: Despite growth, the market faces challenges such as high costs and the availability of alternative therapies.
  • Emerging Trends: Innovations in drug formulations and expanding use in developing countries are key trends shaping the market.

FAQs

What is the primary indication for Venofer (iron sucrose injection)?

Venofer is primarily indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.

What are the key drivers of the Venofer market?

The key drivers include the increasing prevalence of iron deficiency anemia, growing demand for safe and effective iron replacement therapies, and increasing awareness among healthcare professionals and patients.

What are the main challenges facing the Venofer market?

The main challenges include the high cost of Venofer, potential side effects, and the availability of alternative iron replacement therapies.

Who are the leading players in the Venofer market?

Luitpold Pharmaceuticals is a key player in the Venofer market.

What is the projected market size for Venofer by 2030?

The global market for Venofer is forecasted to reach $174.9 million by 2030, growing at a CAGR of 5.9% during the forecast period of 2024-2030.

Sources

  1. FDA Clinical Review: Min Lu, M.D., M.P.H. NDA 21135/S-024 Venofer (iron sucrose injection)[1].
  2. Data Insights Market: Venofer (Iron Sucrose Injection) Market Report[2].
  3. SkyQuestT: Intravenous Iron Drugs Market Size, Share, Trends & Forecast | 2032[3].
  4. Valuates Reports: Venofer (Iron Sucrose Injection) - Market Size[4].
  5. GMI Insights: Intravenous Iron Drugs Market Size & Share Report, 2032[5].

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