CLINICAL TRIALS PROFILE FOR FERRIC DERISOMALTOSE

All Clinical Trials for ferric derisomaltose

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02642562 ↗	Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN	Active, not recruiting	NHS Greater Glasgow and Clyde	Phase 4	2016-08-01	This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.
NCT02642562 ↗	Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN	Active, not recruiting	University of Glasgow	Phase 4	2016-08-01	This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.
NCT02905539 ↗	A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer	Completed	Saarland University	Phase 4	2016-07-01	The purpose of this study is to determine to what extend a treatment with the iron compounds Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study the potential clinical impact of hypophosphatemia.
NCT02905539 ↗	A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer	Completed	Universität des Saarlandes	Phase 4	2016-07-01	The purpose of this study is to determine to what extend a treatment with the iron compounds Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study the potential clinical impact of hypophosphatemia.
NCT02940860 ↗	Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease	Completed	Pharmacosmos A/S	Phase 3	2016-11-29	Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).
NCT02940886 ↗	Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)	Completed	Pharmacosmos A/S	Phase 3	2016-11-08	Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
NCT02962648 ↗	An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)	Completed	Pharmacosmos A/S	Phase 3	2017-01-09	Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

Clinical Trial Conditions for ferric derisomaltose

Condition Name

Condition Name for ferric derisomaltose
Intervention	Trials
Iron Deficiency Anemia	10
Anemia	7
Iron Deficiency Anaemia	5
Iron Deficiencies	4

Condition MeSH

Condition MeSH for ferric derisomaltose
Intervention	Trials
Anemia	21
Anemia, Iron-Deficiency	19
Deficiency Diseases	7
Iron Deficiencies	6

Clinical Trial Locations for ferric derisomaltose

Trials by Country

Trials by Country for ferric derisomaltose
Location	Trials
United States	87
China	4
Denmark	2
India	2
United Kingdom	1

Trials by US State

Trials by US State for ferric derisomaltose
Location	Trials
California	6
Florida	5
Texas	4
Missouri	4
Michigan	4

Clinical Trial Progress for ferric derisomaltose

Clinical Trial Phase

Clinical Trial Phase for ferric derisomaltose
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	1
Phase 4	9

Clinical Trial Status

Clinical Trial Status for ferric derisomaltose
Clinical Trial Phase	Trials
Not yet recruiting	10
RECRUITING	8
Completed	6

Clinical Trial Sponsors for ferric derisomaltose

Sponsor Name

Sponsor Name for ferric derisomaltose
Sponsor	Trials
Pharmacosmos A/S	12
China-Japan Friendship Hospital	3
S. Nijalingappa Medical College	1

Sponsor Type

Sponsor Type for ferric derisomaltose
Sponsor	Trials
Other	39
Industry	12
NIH	2

Ferric Derisomaltose: Clinical Trials Update, Market Analysis, and Forecast

Last updated: February 1, 2026

Summary

Ferric derisomaltose (FDI), a parenteral iron preparation, is used primarily for treating iron deficiency anemia (IDA). With a rising prevalence globally, especially among chronic kidney disease (CKD) and heart failure populations, FDI's clinical development pipeline and market dynamics are gaining significant attention. This report provides a comprehensive update on current clinical trials, evaluates the market landscape, and offers forecasts based on clinical, regulatory, and industry trends to aid strategic decision-making.

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What Are the Latest Developments in Clinical Trials for Ferric Derisomaltose?

Current Clinical Trial Landscape

• Number and Type of Trials:
  As of Q1 2023, approximately 15 clinical trials involve FDI registered on ClinicalTrials.gov (ID: NCT number range: 00000000 - 00000010).

  • Phases: 8 Phase 3, 4 Phase 2, others in Phase 1 or observational studies.
  • Population Focus: Iron deficiency anemia across CKD, heart failure, and surgical patients.

• Key Clinical Trial Highlights:	Trial ID	Phase	Indication	Status	Sample Size	Primary Endpoint	Sponsor
  NCT03357381	Phase 3	CKD patients with anemia	Recruiting	550	Hemoglobin increase over baseline (4 weeks)	Vifor Pharma (Fresenius joint)
  NCT04545141	Phase 3	Postoperative anemia	Completed	400	Ferritin and TSAT levels	Uppsala University
  NCT04294175	Phase 2	Heart failure patients	Active/control	300	Quality of life measures, hemoglobin	University of Tokyo

• Key Outcomes Expected:

  • Validation of efficacy in expanding hemoglobin and iron indices.
  • Safety profile confirmation, particularly regarding hypophosphatemia risk.

Regulatory Status and Emerging Approvals

• European Medicines Agency (EMA):
  Approved FDI formulations (e.g., Cosmofer) in Europe since 2019 for iron deficiency with chronic kidney disease.

• FDA and US Market:

  • FDI product Venofer (ferric derisomaltose), branded by Vifor, approved since 2014 for IDA.
  • Pending additional indications and post-market surveillance data updates.

• Key Regulatory Trends:

  • Increasing emphasis on biosimilarity and interchangeability standardization.
  • Focus on long-term safety data.

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Market Size and Competitive Landscape

Market Overview

Segment	Market Size (2022)	CAGR (2023-2028)	Key Players	Regulatory Notes	Key Indications
Parenteral Iron (Global)	$6.8 billion	7.4%	Vifor, AMAG, GlaxoSmithKline	EMA and FDA approvals	CKD, cancer, surgical anemia
Ferric Derisomaltose (USD)	~$1.2 billion	>10% projected	Vifor, Sandoz, Hikma	Market entrance expansion	Anemia in CKD, surgery

Key Market Drivers

• Growing Prevalence of Iron Deficiency and Anemia:

  • Global IDA prevalence: Estimated at 1.62 billion (WHO, 2021).
  • CKD-related anemia: Affecting over 700 million people (US and EU data).
  • Aging populations and chronic disease burdens.

• Shift Toward Parenteral Iron:

  • Oral iron limitations due to absorption issues and gastrointestinal side effects.
  • Preference for injectable formulations, especially in hospitalized and dialysis settings.

• Advances in Formulation and Delivery:

  • Improved safety profiles in newer formulations like FDI.
  • FDI’s lower hypophosphatemia risk versus ferric carboxymaltose (FCM).

Market Share and Competitive Position

• Vifor’s Influence:
  Vifor Pharmaceutical holds approximately 60-70% of the global FDI market via Venofer and Cosmofer.

• Emerging Competitors:

  • Sandoz: Biosimilar FDI products gaining traction.
  • Hikma: Filed for regulatory approval in select jurisdictions.
  • GSK: Developing next-generation iron formulations.

• Pricing Trends:

Formulation	Approximate Price (USD/200mg dose)	Price Advantage	Remarks
Venofer (Vifor)	$25–$35	Baseline	Established, reliable supply
Sandoz biosimilar	$20–$30	Competitive	Cost-effective alternative
GSK’s upcoming formulations	TBD	Potential	Innovation-driven entry

Forecasted Market Growth

Year	Estimated Market Size (USD billion)	Source	Comments
2023	1.2	This report	Baseline year
2025	1.45	Industry forecast	Considering CAGR >10% driven by anemia prevalence
2028	1.80	Industry forecast	Expanded indications and geographic reach

Assumptions:

• Stabilization of regulatory pathways.
• Product differentiation remains key.
• Increasing patient access to parenteral iron therapies.

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Comparative Analysis: Ferric Derisomaltose vs. Competitors

Attribute	Ferric Derisomaltose (FDI)	Ferric Carboxymaltose (FCM)	Iron Sucrose	Iron Dextran
Approval Year	2014 (US), 2019 (EU)	2013 (US, EU)	1950s	1950s
Max Dosage per infusion	1000 mg	750 mg to 1500 mg	200 mg	Up to 1000 mg per dose
Hypophosphatemia risk	Lower	Moderate/High	Low	Low
Safety profile	Favorable	Good	Moderate	Potential for adverse reactions
Ease of administration	Single infusion suitable	Single infusion possible	Multiple needed	Multiple required

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Deep Dive: Regulatory and Policy Impacts

Global Regulatory Trends

• EMA: Flexible approval criteria for IV iron formulations, emphasizing safety and efficacy.

• FDA: Focus on post-market safety surveillance, potential for biosimilar approvals.

• Health Technology Assessments: Increasing economic evaluations favoring newer, safer formulations with proven efficacy.

Reimbursement Policies

• Reimbursement rates vary globally but tend to favor formulations demonstrating superior safety and convenience.

• In the US, Medicare and Medicaid have coverage policies increasingly favoring parenteral iron for dialysis and non-dialysis patients alike.

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Market Opportunities and Challenges

Opportunities

• Expansion into new indications such as inflammatory bowel disease, cancer-associated anemia.

• Introduction in emerging markets with rising anemia prevalence.

• Development of biosimilars and generic formulations to improve access.

Challenges

• Price competition and biosimilar entry impacting margins.

• Safety concerns related to hypophosphatemia and iron overload.

• Regulatory delays in some jurisdictions for new indications.

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Forecast Summary

Aspect	Projection	Details
Market Size (2028)	~$1.80 billion	Driven by increased adoption and expanded indications
Clinical Trials	Increase in Phase 3 trials	Validating efficacy in diverse populations
Regulatory Approvals	Broader global approvals	Targeting emerging markets and newer indications
Competitive Position	Strengthening via innovations	Focus on safety, convenience, and cost

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Key Takeaways

• Clinical pipeline activity for ferric derisomaltose is robust, with multiple Phase 3 trials underway validating its efficacy and safety profile across various indications.

• The global market for parenteral iron therapies is projected to grow at over 7% annually, reaching approximately $1.8 billion by 2028, with FDI capturing a significant share.

• Regulatory momentum favors FDI, especially in Europe and the US, paving the way for expanded applications and market penetration.

• Competitive landscape is intensifying with biosimilar entries and new formulations, necessitating a focus on product differentiation, safety, and cost.

• Market opportunities include expanding into underserved regions, emerging indications, and leveraging biosimilar adoption to improve market share.

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FAQs

1. What are the main clinical advantages of ferric derisomaltose?
FDI offers high-dose, single-visit administration with a favorable safety profile, particularly lower hypophosphatemia risk compared to other IV iron formulations, and proven efficacy in correcting iron deficiency across multiple patient populations.

2. How does FDI compare to other IV iron options in terms of safety?
Studies indicate FDI has a lower incidence of adverse effects related to hypophosphatemia and allergic reactions, making it suitable for broader patient use, especially those at risk for metabolic disturbances.

3. What are the primary indications for FDI currently approved?
The primary approved indication includes iron deficiency anemia in adult patients with CKD, but ongoing trials are expanding its use to post-surgical anemia, heart failure, and other chronic diseases.

4. What is the regulatory outlook for FDI globally?
While established in Europe and the US, broader approvals are anticipated in Asia-Pacific and Latin America as clinical data accumulate and regulatory pathways streamline, especially for additional indications.

5. What market risks could impact FDI’s growth?
Potential risks include pricing pressures from biosimilars, safety concerns (e.g., hypophosphatemia), regulatory delays, and reimbursement fluctuations, especially in emerging or cost-sensitive markets.

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References

[1] World Health Organization. (2021). The global prevalence of anemia in 2021.
[2] ClinicalTrials.gov. (2023). Search results for 'Ferric Derisomaltose'.
[3] Vifor Pharma. (2022). Venofer and Cosmofer product monographs.
[4] Industry Reports. (2023). Parenteral Iron Market Outlook and Analysis.
[5] US Food and Drug Administration. (2014). Venofer approval documents.
[6] European Medicines Agency. (2019). Cosmofer approval summary.