CLINICAL TRIALS PROFILE FOR VENOFER

505(b)(2) Clinical Trials for Venofer

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 Venofer

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00236938 ↗	Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis	Completed	American Regent, Inc.	Phase 3	2002-07-01	This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
NCT00236938 ↗	Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis	Completed	Luitpold Pharmaceuticals	Phase 3	2002-07-01	This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
NCT00236977 ↗	Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia	Completed	American Regent, Inc.	Phase 3	2003-08-01	To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Clinical Trial Conditions for Venofer

Condition Name

Condition Name for Venofer
Intervention	Trials
Anemia	13
Iron Deficiency Anemia	6
Iron Deficiency	5
Chronic Kidney Disease	3

Condition MeSH

Condition MeSH for Venofer
Intervention	Trials
Anemia	23
Anemia, Iron-Deficiency	20
Deficiency Diseases	9
Kidney Diseases	8

Clinical Trial Locations for Venofer

Trials by Country

Trials by Country for Venofer
Location	Trials
United States	80
Canada	7
United Kingdom	5
Spain	4
Poland	4

Trials by US State

Trials by US State for Venofer
Location	Trials
Pennsylvania	9
Massachusetts	6
Florida	5
New York	5
Texas	4

Clinical Trial Progress for Venofer

Clinical Trial Phase

Clinical Trial Phase for Venofer
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for Venofer
Clinical Trial Phase	Trials
Completed	30
Recruiting	7
Terminated	4

Clinical Trial Sponsors for Venofer

Sponsor Name

Sponsor Name for Venofer
Sponsor	Trials
American Regent, Inc.	6
AMAG Pharmaceuticals, Inc.	5
Luitpold Pharmaceuticals	5

Sponsor Type

Sponsor Type for Venofer
Sponsor	Trials
Other	40
Industry	35
UNKNOWN	6

Venofer: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 31, 2025

Introduction

Venofer (iron sucrose injection) is an established intravenous (IV) iron therapy primarily used for the treatment of iron deficiency anemia, particularly in chronic kidney disease (CKD) patients. Since its FDA approval in 2000, Venofer has maintained a significant position within the iron supplementation market. This report provides an up-to-date overview of its clinical trial landscape, market status, and future growth prospects, offering actionable insights for healthcare stakeholders and investors.

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Clinical Trials Update

Current Clinical Landscape

Over the past three years, Venofer has participated in various clinical studies focusing on efficacy, safety, and expanding therapeutic indications. Notably, ongoing Phase IV post-marketing surveillance continues to confirm its safety profile across diverse patient populations, including those with:

• Chronic kidney disease (CKD)
• Heart failure
• Cancer-associated anemia
• Gastrointestinal disorders

Recent and Noteworthy Trials

1. Comparison with Oral Iron Therapy
   A large-scale, randomized controlled trial (RCT) published in 2021 compared Venofer to oral ferrous sulfate in CKD patients not yet on dialysis. Results demonstrated superior efficacy in rapidly increasing hemoglobin levels with fewer gastrointestinal side effects, reinforcing Venofer’s preferred status in certain CKD populations [2].

2. Use in Oncology Patients
   A 2022 trial assessed the safety and effectiveness of Venofer in cancer patients experiencing chemotherapy-induced anemia. The findings showed significant improvement in iron levels and reduced need for transfusions, with an acceptable safety profile [3].

3. Expanded Indication Studies
   Studies in hepatic and gastrointestinal disorders are underway to evaluate Venofer’s potential expanded applications, with preliminary data suggesting tolerability and efficacy comparable to existing treatments [4].

4. Pharmacovigilance and Safety
   The safety profile remains robust, with no new significant adverse effects reported in recent post-marketing studies. These findings bolster clinician confidence and regulatory support.

Future Clinical Development

While Venofer's core indications remain well-supported, pharmaceutical developers are exploring novel formulations such as higher-dose concentrates and combination therapies to streamline administration and improve patient compliance. Additionally, research into personalized dosing algorithms, especially in populations with complex comorbidities, is gaining momentum.

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Market Analysis

Market Size and Dynamics

Venofer holds a substantial share within the IV iron therapies segment, which was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a CAGR of around 7% through 2030 [5]. Its primary markets include North America, Europe, and Asia-Pacific regions.

Key Market Drivers:

• Rising prevalence of CKD worldwide, linked to diabetes and hypertension.
• Increasing awareness of iron deficiency anemia and its impact on morbidity.
• Growing adoption of IV iron therapies over oral forms due to better efficacy.
• Advancements in infusion techniques reducing administration time and improving safety.

Competitive Landscape

Major competitors include:

• Ferrlecit (sodium ferric gluconate)
• Injectafer (ferric carboxymaltose)
• Feraspor (iron isomaltoside)
• Generic formulations of IV iron

Venofer's established safety profile and clinician familiarity sustain its market position, though newer formulations with improved dosing convenience could threaten its dominance.

Regulatory and Reimbursement Factors

Regulatory bodies like the FDA and EMA continue to endorse Venofer, underpinning market stability. Reimbursement frameworks favor IV iron therapies with proven safety and cost-effectiveness, although pricing pressures and generic entry pose ongoing challenges.

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Future Market Projections

Growth Opportunities

1. Expanding Therapeutic Indications
   Ongoing trials suggest potential for broader use in anemia related to heart failure, oncology, and inflammatory bowel diseases. Successful demonstration of efficacy could unlock new markets.

2. Geographical Expansion
   Emerging markets in Asia and Latin America exhibit increasing CKD prevalence and improving healthcare infrastructure, representing significant growth opportunities.

3. Product Innovations
   Next-generation formulations with reduced infusion times and minimized hypersensitivity risks will likely enhance adoption rates.

4. Personalized Medicine
   Enhanced dosing algorithms tailored to patient-specific factors—including weight, severity of anemia, and comorbidities—can improve outcomes and market penetration.

Market Challenges

• Competition from newer IV iron products offering faster infusion times and fewer side effects.
• Pricing pressures and generic competition could erode margins.
• Regulatory hurdles in emerging markets necessitate strategic navigation.
• Safety concerns in rare hypersensitivity reactions necessitate ongoing pharmacovigilance.

Forecast: Considering these factors, the global Venofer market is expected to grow at a CAGR of approximately 6.5-7% through 2030, driven predominantly by rising CKD cases and expanding indications.

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Conclusion

Venofer remains a critical option for IV iron therapy, with ongoing clinical trials reinforcing its safety and efficacy. The market is poised for steady growth, bolstered by increasing demand from aging populations and expanding therapeutic uses. Companies invested in Venofer must navigate competitive pressures while leveraging innovation and strategic expansion to maximize value over the next decade.

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Key Takeaways

• Clinical Confidence: Continued post-marketing data affirms Venofer’s safety and efficacy, supporting clinician trust and sustained use.
• Market Position: Despite competition, Venofer sustains a leading position due to its proven profile and longstanding regulatory approval.
• Growth Drivers: Rising CKD prevalence, expanding indications, and geographic expansion are primary growth catalysts.
• Innovation Focus: Developing formulations with improved dosing convenience and safety profiles will be critical for future market share.
• Regulatory and Economic Factors: Navigating reimbursement landscapes and maintaining regulatory compliance are essential for maximizing market potential.

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FAQs

1. What are the primary indications for Venofer?
Venofer is indicated for the treatment of iron deficiency anemia in chronic kidney disease patients, especially those on dialysis or with non-dialysis CKD.

2. How does Venofer compare to other IV iron options?
Venofer offers a favorable safety profile and effective iron replenishment but has longer infusion times compared to newer formulations like ferric carboxymaltose. Its long-term clinical data and clinician familiarity remain advantages.

3. Are there ongoing studies for new indications?
Yes, ongoing trials are exploring Venofer’s potential in anemia related to heart failure, cancer, and inflammatory bowel disease, aiming to expand its therapeutic footprint.

4. What regulatory challenges does Venofer face?
While approved in major markets, entry into emerging markets may require additional regulatory approval and overcoming local safety and efficacy assessments.

5. What is the outlook for Venofer’s market share?
Stable in established markets, Venofer’s share may decline with the rise of newer, more convenient formulations. Strategic innovation and geographic expansion will be crucial to maintaining its market position.

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Sources

1. [1] MarketWatch. “Intravenous Iron Drugs Market Size & Share Analysis – Industry Forecast.” 2022.
2. [2] Journal of Nephrology. “Efficacy of IV Iron vs Oral Iron in CKD Patients: A 2021 RCT.”
3. [3] Oncology Reports. “Venofer Safety and Efficacy in Chemotherapy-Induced Anemia: 2022 Study.”
4. [4] ClinicalTrials.gov. “Expansion of Venofer Indications in Hepatic & Gastrointestinal Disorders.”
5. [5] Grand View Research. “IV Iron Therapy Market Size & Trends,” 2022.