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	22
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	79
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
Missouri	4

Clinical Trial Progress for VENOFER

Clinical Trial Phase

Clinical Trial Phase for VENOFER
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	13
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for VENOFER
Clinical Trial Phase	Trials
Completed	27
Recruiting	6
Terminated	4

Clinical Trial Sponsors for VENOFER

Sponsor Name

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

Sponsor Type

Sponsor Type for VENOFER
Sponsor	Trials
Other	39
Industry	32
NIH	1

VENOFER Market Analysis and Financial Projection

Venofer (Iron Sucrose Injection): Clinical Trials, Market Analysis, and Projections

Introduction

Venofer, an iron sucrose injection, is a crucial treatment for iron deficiency anemia, particularly in patients undergoing hemodialysis. This article delves into the recent clinical trials, market analysis, and future projections for Venofer.

Clinical Trials: The PIVOTAL Study

One of the most significant clinical trials involving Venofer is the Proactive IV irOn Therapy in haemodiALysis patients (PIVOTAL) trial. This randomized controlled study was designed to compare the efficacy and safety of a proactive, high-dose intravenous iron sucrose regimen with a reactive, low-dose regimen in patients on maintenance hemodialysis.

Key Findings of the PIVOTAL Trial

• The trial demonstrated that a proactive, high-dose Venofer regimen resulted in a statistically significant reduction in the risk of death or major cardiovascular events compared to a reactive, low-dose regimen (P=0.04)[1].
• High-dose Venofer reduced the incidence of myocardial infarctions and hospitalizations for heart failure.
• It also led to a lower need for erythropoiesis-stimulating agents and blood transfusions.
• There was no significant difference in infection rates between the two groups.

Study Design and Funding

The PIVOTAL trial involved 2,141 patients from 50 sites in the United Kingdom over a period of up to 4.5 years. The study was funded by Kidney Research UK and supported by an unrestricted grant from Vifor Fresenius Medical Care Renal Pharma Ltd., which also provided Venofer free of charge. However, the company had no input into the study design or delivery[1].

Market Analysis

Current Market Size and Forecast

The global market for Venofer (Iron Sucrose Injection) was estimated to be worth US$ 110 million in 2023. It is forecasted to grow to US$ 174.9 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.9% during the forecast period of 2024-2030[2].

Market Segments and Players

The Venofer market is segmented by type and application, with the primary applications being in adult and pediatric patients. Luitpold Pharmaceuticals is one of the main players in this market[2].

Broader Intravenous Iron Drugs Market

The global intravenous iron drugs market, which includes Venofer, was estimated at USD 3.03 billion in 2023 and is expected to expand at a CAGR of 9.2% from 2024 to 2030. This growth is driven by advancements in drug delivery systems, such as nanoparticle-based formulations, and innovative infusion systems that enhance iron absorption and minimize side effects[3].

Technological Advancements

Drug Delivery Systems

The intravenous iron drugs market is witnessing significant technological advancements, including the development of nanoparticle-based formulations. These formulations offer targeted delivery mechanisms, reducing the need for frequent dosing and adverse reactions. For instance, the FDA approval of Injectafer (ferric carboxymaltose injection) in 2021 for pediatric patients with iron deficiency anemia highlights the innovation in this field[3].

Recent Approvals

In June 2023, Daiichi Sankyo and American Regent received FDA approval for INJECTAFER (ferric carboxymaltose injection) to treat iron deficiency in adults with heart failure, further expanding the treatment options in this market[3].

Efficacy and Safety

Study A (HDD-CKD): Venofer in Patients Receiving Erythropoietin

A key study that led to the FDA approval of Venofer involved evaluating its efficacy and safety in hemodialysis-dependent chronic kidney disease (HDD-CKD) patients who were also receiving erythropoietin therapy. The study showed significant increases in hemoglobin, hematocrit, serum ferritin, and transferrin saturation levels, while also reducing the need for erythropoiesis-stimulating agents[4].

Market Drivers and Challenges

Drivers

• Increasing approvals and launches of new intravenous iron drugs.
• Advancements in drug delivery systems.
• Growing demand for effective treatments for iron deficiency anemia in various patient populations, including those with chronic kidney disease and heart failure[3].

Challenges

• Volatility in raw material prices and geopolitical factors can impact the cost and availability of these drugs.
• Competition from alternative treatments and the need for continuous innovation to maintain market share[3].

Regional Market Analysis

North America

The North America region accounted for the largest share of the intravenous iron drugs market in 2023, primarily due to the increasing approvals and launches of new IV drugs in the U.S.[3].

Key Takeaways

• Venofer has demonstrated significant clinical benefits in reducing cardiovascular events and improving anemia management in hemodialysis patients.
• The global market for Venofer is expected to grow at a CAGR of 5.9% from 2024 to 2030.
• Technological advancements in drug delivery systems are driving the growth of the broader intravenous iron drugs market.
• The market is driven by increasing demand for effective treatments for iron deficiency anemia, but faces challenges such as raw material price volatility and competition from alternative treatments.

FAQs

What were the key findings of the PIVOTAL trial for Venofer?

The PIVOTAL trial showed that a proactive, high-dose Venofer regimen reduced the risk of death or major cardiovascular events, myocardial infarctions, and hospitalizations for heart failure compared to a reactive, low-dose regimen[1].

What is the forecasted market size for Venofer by 2030?

The global market for Venofer is forecasted to reach US$ 174.9 million by 2030, growing at a CAGR of 5.9% from 2024 to 2030[2].

Who are the main players in the Venofer market?

Luitpold Pharmaceuticals is one of the main players in the Venofer market[2].

What technological advancements are driving the intravenous iron drugs market?

Advancements include nanoparticle-based formulations and innovative infusion systems that enhance iron absorption and minimize side effects[3].

What are the primary applications of Venofer?

The primary applications of Venofer are in adult and pediatric patients[2].

What are the challenges facing the Venofer market?

Challenges include volatility in raw material prices, geopolitical factors, and competition from alternative treatments[3].

Sources

1. Vifor Pharma Press Release: Updated on Analysis of Venofer in High Dosage Study.
2. Valuates Reports: Venofer (Iron Sucrose Injection) - Market Size.
3. Grand View Research: Intravenous Iron Drugs Market Size And Share Report, 2030.
4. Venofer.com: STUDY A (HDD-CKD): Venofer in Patients Receiving Erythropoietin.