CLINICAL TRIALS PROFILE FOR IRON SUCROSE

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.

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.
NCT00125996 ↗	Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure	Unknown status	4th Military Hospital, Poland	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.
NCT00125996 ↗	Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure	Unknown status	Wexham Park 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.
NCT00125996 ↗	Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure	Unknown status	National Heart and Lung Institute	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.
NCT00145652 ↗	Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders.	Completed	Sundsvall Hospital	Phase 3	2003-12-01	This is a multi-center open label, randomized phase-3 study with stratification according to diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the effect on iron kinetics by the rHuEPO treatment with or without intravenous iron supplementation in anemic patients with LPD not receiving antineoplastic therapy will be studied. The study will be performed according to the ICH-GCP guidelines. In order to be eligible, the patient must consent in writing that he/she agrees to participate in the study. The patient recruitment period is estimated to be no longer than 18 months.

Clinical Trial Conditions for iron sucrose

Condition Name

Condition Name for iron sucrose
Intervention	Trials
Anemia	25
Pain	15
Iron Deficiency Anemia	15
Iron Deficiency	7

Condition MeSH

Condition MeSH for iron sucrose
Intervention	Trials
Anemia, Iron-Deficiency	43
Anemia	41
Deficiency Diseases	17
Kidney Diseases	16

Clinical Trial Locations for iron sucrose

Trials by Country

Trials by Country for iron sucrose
Location	Trials
United States	182
Canada	25
China	12
Germany	9
Spain	9

Trials by US State

Trials by US State for iron sucrose
Location	Trials
Pennsylvania	15
Florida	11
Massachusetts	10
Maryland	10
California	9

Clinical Trial Progress for iron sucrose

Clinical Trial Phase

Clinical Trial Phase for iron sucrose
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for iron sucrose
Clinical Trial Phase	Trials
Completed	100
Unknown status	19
Recruiting	19

Clinical Trial Sponsors for iron sucrose

Sponsor Name

Sponsor Name for iron sucrose
Sponsor	Trials
American Regent, Inc.	13
Luitpold Pharmaceuticals	12
Pharmacosmos A/S	6

Sponsor Type

Sponsor Type for iron sucrose
Sponsor	Trials
Other	180
Industry	89
UNKNOWN	7

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

Last updated: October 31, 2025

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Introduction

Iron sucrose, a non-dextrin colloidal iron preparation, is widely used in the management of iron deficiency anemia, especially in chronic kidney disease (CKD) patients. As a parenteral iron formulation, it offers advantages over oral iron supplements, particularly in cases of malabsorption or intolerance. This analysis provides a comprehensive overview of recent clinical trial developments, market dynamics, and future growth projections for iron sucrose, equipping stakeholders with actionable insights.

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Clinical Trials Update

Recent Clinical Trials and Emerging Research

Recent years have seen a surge in clinical research focusing on optimizing iron sucrose's efficacy and safety profile. Notably, multiple phase IV studies have evaluated long-term safety, comparative effectiveness, and patient outcomes.

• Safety and Efficacy in CKD Patients:
  A 2021 multicenter trial published in Nephrology Dialysis Transplantation assessed repeated iron sucrose infusions over a 12-month period in CKD patients. Results demonstrated sustained hemoglobin increases with minimal adverse events, reaffirming iron sucrose’s safety for long-term use [1].

• Comparison with Other Parenteral Iron Preparations:
  Randomized controlled trials comparing iron sucrose with ferric carboxymaltose indicate comparable efficacy but favorable safety profiles for iron sucrose, particularly regarding infusion reactions and hypersensitivity [2].

• Use in Anemia of Chronic Disease:
  Recent investigations incorporate iron sucrose in anemia management across diverse populations. A 2022 study demonstrated improved hemoglobin levels and reduced erythropoiesis-stimulating agent (ESA) requirements in patients with inflammatory bowel disease, suggesting expanding indications [3].

Innovations in Formulation and Delivery

Research efforts are also directed toward enhancing formulation and administration protocols. Notably:

• Modified Dosing Regimens:
  Studies proposing simplified dosing schedules aim to improve patient compliance and reduce healthcare burdens.

• Bioavailability Studies:
  Ongoing trials assess the pharmacokinetics of iron sucrose with potential modifications to improve bioavailability, which could lead to innovative delivery systems or combination therapies [4].

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Market Analysis

Current Market Landscape

The iron sucrose market operates within the broader intravenous iron supplement segment, which was valued at approximately USD 2.4 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of around 7.2% through 2030 [5].

Key regional markets include North America, Europe, Asia-Pacific, Latin America, and the Middle East:

• North America: Dominates owing to high CKD prevalence, well-established healthcare infrastructure, and robust clinical adoption. The U.S. accounts for nearly 40% of the global market share.

• Europe: A mature market with consistent growth driven by aging populations and updated clinical guidelines favoring IV iron therapies.

• Asia-Pacific: Exhibits the fastest growth rates, with increasing CKD prevalence, improving healthcare access, and rising awareness about anemia management.

Market Drivers

• Rising CKD and Anemia Incidence:
  CKD affects over 10% of the global population, with anemia as a common comorbidity. According to the Global Kidney Disease Data, CKD-related anemia drives significant demand for parenteral iron products like iron sucrose [6].

• Shift from Oral to Parenteral Iron:
  Clinical guidelines increasingly favor IV iron for rapid correction and better tolerability, especially in hemodialysis patients, enhancing market growth.

• Expanding Non-Dialysis Indications:
  Research suggesting efficacy in broader anemia indications, including inflammatory and oncological settings, broadens the market scope.

• Reimbursement and Healthcare Policies:
  Reimbursement codes and clinical guidelines supportive of IV iron administration facilitate market penetration, particularly in developed regions.

Competitive Landscape

Major players include Vifor Pharma (Ferinject / Injectafer), Hikma Pharmaceuticals, and Baxter International. While iron sucrose has been prominent, newer formulations like ferric carboxymaltose and ferumoxytol are challenging its market share due to convenience and dosing advantages.

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Market Projection and Future Trends

Forecast Outlook

The global iron sucrose market is expected to grow at a CAGR of approximately 6.8% to 7.2% over the next decade, reaching an estimated USD 4.25 billion by 2030. Growth will be driven primarily by:

• Increased CKD Patient Population:
  Advances in nephrology and early diagnosis techniques will sustain demand.

• Enhanced Clinical Evidence:
  Ongoing trials reinforcing safety and efficacy will bolster clinician confidence and prescription rates.

• Emerging Markets:
  Rapid economic growth in Asia-Pacific and Latin America will unlock new patient bases.

Potential Disruption Factors

• Alternative Therapies:
  The advent of long-acting IV iron formulations with single-dose regimens may alter the landscape, possibly impacting iron sucrose's market share unless it adapts accordingly.

• Regulatory and Patent Dynamics:
  Patent expiries and regulatory considerations could influence pricing, availability, and competition.

• Technological Innovations:
  Nanoparticle-based delivery systems and conjugates could improve bioavailability, posing future challenges for traditional iron sucrose formulations.

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Conclusion

Iron sucrose remains a cornerstone in the management of iron deficiency anemia, especially within CKD populations. Recent clinical trials underscore its safety, tolerability, and efficacy, reinforcing its value proposition. Market analysis indicates sustained growth driven by aging demographics, rising disease prevalence, and evolving clinical protocols favoring intravenous iron use.

Stakeholders should monitor ongoing research and regulatory developments, capitalize on expanding markets, and consider innovation avenues to maintain competitiveness in this evolving landscape.

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Key Takeaways

• Clinical Evidence Reinforces Safety and Efficacy:
  Ongoing research confirms iron sucrose’s long-term safety and comparable efficacy to newer formulations.

• Market Expansion Driven by CKD and Anemia Trends:
  The increasing burden of CKD globally sustains demand; Asia-Pacific’s growth rate offers regional opportunities.

• Emerging Indications and Formulations May Shift Dynamics:
  Expansion into non-CKD indications and innovations in drug delivery can impact future market share.

• Competitive Landscape Requires Strategic Positioning:
  Major players need to innovate and optimize formulations to counter newer, more convenient alternatives.

• Regulatory and Reimbursement Policies Are Critical:
  Supportive health policies and reimbursement frameworks will be vital to capitalize on market opportunities.

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FAQs

1. What are the key advantages of iron sucrose over oral iron supplements?
Parenteral iron sucrose offers rapid correction of iron deficiency, better absorption in cases of malabsorption, and improved tolerability in patients intolerant to oral iron, especially in CKD populations.

2. How does recent clinical trial data influence the clinical use of iron sucrose?
Latest trials support its safety profile, long-term efficacy, and expanded indications, encouraging clinicians to prefer iron sucrose in appropriate cases.

3. What are the main factors driving the growth of the iron sucrose market?
Increasing CKD prevalence, clinical guidelines favoring IV iron, expanding indications, and healthcare policy support drive market growth.

4. How might emerging alternative formulations impact iron sucrose’s market?
Long-acting formulations with single-dose regimens and better convenience could reduce demand unless iron sucrose evolves or demonstrates unique advantages.

5. What future research areas could expand iron sucrose’s clinical applications?
Innovations in drug delivery, combination therapies, and studies in non-CKD anemia populations will likely broaden its use cases.

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References

1. Nephrol Dial Transplant. 2021;36(2):278-285.
2. J Clin Med. 2022;11(6):1532.
3. Inflamm Bowel Dis. 2022;28(4):533-540.
4. Pharmacology. 2023;101(1):45-53.
5. MarketWatch. 2023. "Intravenous Iron Market Size, Share & Trends."
6. Lancet. 2020;396(10250):607-620.

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Note: All data are based on the latest available literature and market reports as of 2023.