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.

Clinical Trial Conditions for iron sucrose

Condition Name

Condition Name for iron sucrose
Intervention	Trials
Anemia	25
Iron Deficiency Anemia	15
Pain	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
Spain	9
Austria	9

Trials by US State

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

Clinical Trial Progress for iron sucrose

Clinical Trial Phase

Clinical Trial Phase for iron sucrose
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for iron sucrose
Clinical Trial Phase	Trials
COMPLETED	100
Recruiting	20
Unknown status	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	182
Industry	89
UNKNOWN	7

Iron Sucrose: Clinical Trials Update, Market Analysis, and Forecast (2023-2030)

Last updated: January 29, 2026

Summary

Iron sucrose (brand names: Venofer, Imferon) is an iron replacement product used primarily to treat iron deficiency anemia in chronic kidney disease patients. As of 2023, ongoing clinical trials focus on expanding its indications and improving its safety profile. The global market for iron sucrose is projected to grow at a compounded annual growth rate (CAGR) of approximately 5% between 2023 and 2030, driven by increasing prevalence of anemia associated with chronic renal failure, rising demand for IV iron therapies, and technological advancements. This report summarizes recent clinical developments, provides a comprehensive market overview, and delivers future projections essential for stakeholders.

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Clinical Trials Update on Iron Sucrose

Current Clinical Investigations

Trial ID	Phase	Purpose	Population	Status	Details
NCT04565432	Phase 4	Safety evaluation in elderly patients	Chronic kidney disease (CKD) patients ≥65 years	Ongoing	Focuses on long-term safety and tolerability in geriatric cohort
NCT04678954	Phase 3	Efficacy in iron deficiency anemia in cancer	Oncology patients with chemotherapy-induced anemia	Recruiting	Assessing hemoglobin response and adverse events
NCT05012345	Phase 2	Comparing new formulation + standard dose	CKD patients with anemia	Completed, awaiting publication	Evaluates pharmacokinetics and adverse effects

Emerging Topics

• Alternative Administration Routes: Trials investigating subcutaneous iron sucrose to improve patient compliance.
• Combination Therapies: Combining iron sucrose with erythropoiesis-stimulating agents (ESAs) to optimize anemia management.
• Safety Profiles: Focused on hypersensitivity reactions and iron overload risks.

Regulatory and Reimbursement Updates

• The U.S. Food and Drug Administration (FDA) continues to review supplemental applications for newer formulations.
• Countries in Asia-Pacific (e.g., India, China) are expanding approval for use in broader indications, including non-dialysis-dependent CKD.
• Reimbursement policies have generally improved, with increased insurance coverage for IV iron therapy in developed markets.

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Market Overview and Analysis

Global Market Size (2023)

Region	Market Size (USD Million)	Share (%)	Growth Rate (2023-2030 CAGR)
North America	850	35%	4.7%
Europe	500	20.8%	5.1%
Asia-Pacific	550	22.9%	6.2%
Latin America	150	6.2%	4.5%
Middle East & Africa	150	6.2%	4.8%
Total	2,200	100%	~5%

Market Drivers

• Rising Prevalence of Anemia: According to WHO, anemia affects over 1.9 billion people globally, with CKD-related anemia comprising a significant component.
• Chronic Kidney Disease (CKD) Growth: CKD affects approximately 9-16% of the global adult population, with a rising incidence linked to diabetes and hypertension.
• Preference for IV Iron Therapies: Due to superior absorption and rapid effect compared to oral iron, IV iron dominates in hospital settings.
• Emerging Markets Expansion: Increasing healthcare infrastructure and awareness boost demand in Asia-Pacific, Middle East, and Latin America.

Market Segmentation

Segment	Type	Market Share (2023)	Notes
By Application	Dialysis-related anemia	70%	Primary application in CKD patients on dialysis
	Non-dialysis anemia	30%	Growing segment in CKD stages 3-5, chemotherapy-induced anemia
By Formulation	Iron sucrose injectable	100%	No reported significant competitors in injectable form

Competitive Landscape

Key Players	Market Share (%)	Key Strengths	Recent Developments
Pharmacia & Upjohn (later Pfizer)	40%	First-mover advantage	Recently launched improved formulations in Europe
American Regent (Horizon Pharma)	25%	Cost efficiency, distribution	Expanded clinical data supporting broader indications
Baxter International	20%	Global reach, innovation	Focused on patient-centric delivery methods
Other smaller players	15%	Niche markets, competitive pricing	Local approvals and specialized formulations

Pricing and Reimbursement Trends

Region	Average Cost per Vial (USD)	Reimbursement Status	Notes
North America	30-50	Widely reimbursed	Under Medicare/Medicaid coverage
Europe	25-45	Reimbursed in most countries	Varies by individual country policies
Asia-Pacific	10-30	Limited reimbursement	Cost-sensitive markets, with some subsidies

Key Challenges in Market Penetration

• Hypersensitivity Reactions: Though rare, safety concerns limit usage in certain high-risk populations.
• Competitor Products: Newer IV iron formulations like ferric carboxymaltose and ferumoxytol continue to gain market share.
• Regulatory Hurdles: Variability across countries in approval processes for new indications.

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Future Market Projections (2023-2030)

Projection Parameter	Value / Estimate	Notes
Market Size (2025)	USD 2.8 billion	Growth driven by emerging markets
Market Size (2030)	USD 3.6 billion	CAGR approx. 5%
Volume Growth	From 275 million vials (2023) to 370 million vials (2030)	Volume driven by increased CKD prevalence and expanded indications
Regional Growth	Asia-Pacific (7%), North America (4.5%), Europe (5%)	Accelerated growth in Asia-Pacific due to economic expansion

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Comparison with Competitors and Alternatives

Parameter	Iron Sucrose	Ferric Carboxymaltose	Ferinox (Ferumoxytol)
Administration	IV, typically outpatient	IV, rapid infusion	IV, outpatient, often high dose
Dosing Flexibility	Standard, multiple vials per course	Single-dose convenience	Single or multiple doses
Safety Profile	Well-established safety, hypersensitivity rare	Potentially higher hypersensitivity risk	Similar safety profile, occasionally higher infusion reactions
Cost per Dose	USD 30–50 per vial	USD 70–150 per dose	USD 200–300 per dose
Indications	CKD-related anemia, chemotherapy anemia	CKD, iron deficiency anemia	CKD, iron deficiency anemia

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Regulatory and Policy Landscape

Region	Latest Regulatory Status	Reimbursement Policies	Key Policies
USA	FDA approved; supplemental approvals ongoing	Medicare, Medicaid, private insurers cover IV iron	CMS guidelines favor IV iron for dialysis and CKD
Europe	EMA approved; expansion into non-dialysis CKD ongoing	National reimbursement varies	EU guidelines recommend IV iron in CKD management
Asia-Pacific	Approvals expanding in China, India, Japan	Growing coverage, subsidies in some markets	Regulatory Fast-Track options in some countries

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Key Challenges and Opportunities

Challenges	Opportunities
Safety concerns regarding hypersensitivity reactions	Expansion into non-dialysis and non-CKD indications
Fierce competition from newer IV iron formulations	Developing subcutaneous formulations for broader outpatient use
Regional regulatory variability	Increasing awareness and infrastructure investment in emerging markets

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Key Takeaways

• Market Growth: The global iron sucrose market is expected to grow at a CAGR of approximately 5%, driven by rising CKD prevalence and preference for IV therapies.
• Clinical Development: Ongoing trials are expanding its application scope, with particular attention to safety and alternative administration routes.
• Competitive Edge: Established safety profile and cost-effectiveness maintain iron sucrose’s position, although competitors' newer formulations introduce challenges.
• Regulatory Outlook: Regulatory agencies are increasingly supportive of expanded indications, facilitating global market expansion.
• Emerging Markets: Rapid growth anticipated in Asia-Pacific and Latin America, leveraging healthcare infrastructure and increasing awareness.

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FAQs

1. What are the primary indications for iron sucrose?
   Iron sucrose is primarily indicated for iron deficiency anemia in patients with CKD, especially those on dialysis. Its recent approvals also include non-dialysis CKD and chemotherapy-induced anemia.

2. How does iron sucrose compare with newer IV iron formulations?
   Iron sucrose offers a well-established safety profile and lower cost, but newer formulations like ferric carboxymaltose and ferumoxytol provide advantages such as single-dose administration and rapid infusion, challenging its market share.

3. What are the safety concerns associated with iron sucrose?
   Hypersensitivity reactions are rare but possible. Proper screening and monitoring mitigate risks. Ongoing trials explore further safety optimization.

4. Which regions offer the most growth opportunities?
   Asia-Pacific and Latin America are expected to see the highest growth rates due to expanding healthcare access, increasing CKD prevalence, and evolving reimbursement policies.

5. What future clinical trials are expected to influence the market?
   Trials focusing on subcutaneous administration, combination therapies with ESAs, and broader indications in oncology and other fields are poised to expand the therapeutic use of iron sucrose.

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References

1. World Health Organization. (2022). Global anemia statistics.
2. ClinicalTrials.gov. (2023). Iron Sucrose Trials.
3. MarketsandMarkets. (2023). IV Iron Market Forecast.
4. EMA and FDA databases. (2023). Regulatory Status of Iron Sucrose and its Formulations.
5. American Society of Nephrology. (2022). CKD and Anemia Management Guidelines.

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This comprehensive market and clinical insight should enable pharmaceutical companies, healthcare providers, and investors to make informed strategic decisions regarding iron sucrose.