Comparative evaluation of efficacy, safety, cost effectiveness and acceptability of Ferric carboxymaltose versus Iron sucrose for treatment of Iron deficiency anemia in pregnancy - Nil

Start Date30 Apr 2025

Sponsor / Collaborator-

NCT06958822

/ Enrolling by invitationNot ApplicableIIT

Estimation of the Incidence of Methemoglobinemia Associated With Ferric Carboxymaltose Administration

Anemia that develops due to iron deficiency is called iron deficiency anemia. This common condition is treated with iron supplements taken either orally or given through an intravenous (IV) infusion. Ferric carboxymaltose (FCM) is one of the widely used, comparably newer IV iron preparations. Recently, several publications have raised the possibility that FCM may be associated with mild elevations in methemoglobin (metHb), a form of hemoglobin that cannot effectively deliver oxygen to tissues.
Methemoglobinemia is a known, though uncommon, side effect of some drugs. While usually mild and self-limiting, in certain cases it can become clinically significant or even life-threatening. This observational study is being conducted across multiple centers to better understand how often methemoglobinemia occurs after administration of FCM. As part of routine care, venous blood samples will be used to measure metHb levels in patients receiving FCM, and these results will be compared with those from individuals not exposed to the drug.

Start Date14 Apr 2025

Sponsor / Collaborator-

NCT06895993

/ Not yet recruitingPhase 1

A Randomized, Open-label, Parallel, Two-treatment, Single Dose Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions

The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in healthy participants under fasting condition. The main questions it aims to answer are:
* [Question 1] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection (100 mg iron/2 mL) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection licensed by American Regent, Inc. (trade name: Injectafer®, strength: 100 mg iron/2 mL)?
* [Question 2] Is it safe for healthy participants to take ferric carboxymaltose injection (10 mL: 500 mg [calculated by iron]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting condition? Participants will be randomly divided into two groups by stratified blocked randomization, with equal number of healthy participants in each group, to receive test product or reference product according to the protocol below.
* Dosing on D1: Group T (Test product) Group R (Reference product)
* PK blood sample collection
* Safety evaluation

Start Date07 Apr 2025

Sponsor / Collaborator

Sichuan Huiyu Pharmaceutical Co., Ltd.

[+4]

100 Clinical Results associated with Ferric Carboxymaltose

100 Translational Medicine associated with Ferric Carboxymaltose

100 Patents (Medical) associated with Ferric Carboxymaltose

836

Literatures (Medical) associated with Ferric Carboxymaltose

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Evaluating the cost-utility of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anaemia in Norway

Article

Author: Detlie, T. E. ; Karlsen, L. N. ; Nanu, N. ; Pollock, R. F. ; Jørgensen, E.

AIMS:

Iron deficiency anemia (IDA) is among the most common extraintestinal sequelae of inflammatory bowel disease (IBD). Intravenous iron is often the preferred treatment in patients with active inflammation with or without active bleeding, iron malabsorption, or intolerance to oral iron. The aim of the present study was to evaluate the cost-utility of ferric derisomaltose (FDI) versus ferric carboyxymaltose (FCM) in patients with IBD and IDA in Norway.

MATERIALS AND METHODS:

A published patient-level simulation model was used to evaluate the cost-utility of FDI versus FCM in patients with IBD and IDA from a Norwegian national payer perspective. Iron need was modelled based on bivariate distributions of hemoglobin and bodyweight combined with simplified tables of iron need from the FDI and FCM summaries of product characteristics. Patient characteristics and disease-related quality of life data were obtained from the PHOSPHARE-IBD trial. Cost-utility was evaluated in Norwegian Kroner (NOK) over a five-year time horizon.

RESULTS:

Patients required 1.64 fewer infusions of FDI than FCM over five years (5.62 versus 7.26), corresponding to 0.41 fewer infusions per treatment course. The reduction in the number of infusions resulted in cost savings of NOK 5,236 (NOK 35,830 with FDI versus NOK 41,066 with FCM). The need for phosphate testing in patients treated with FCM resulted in further cost savings with FDI (no costs with FDI versus NOK 4,470 with FCM). Total cost savings with FDI were therefore NOK 9,707. FDI also increased quality-adjusted life expectancy by 0.071 quality-adjusted life years (QALYs) driven by reduced incidence of hypophosphatemia and fewer interactions with the healthcare system.

CONCLUSIONS:

FDI resulted in cost savings and improved quality-adjusted life expectancy versus FCM in patients with IDA and IBD in Norway. FDI therefore represents the economically preferable iron formulation in Norwegian patients with IBD and IDA in whom it is indicated.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

A Swedish cost-utility analysis of ferric derisomaltose versus ferric carboxymaltose in the treatment of iron deficiency anemia in patients with inflammatory bowel disease

Article

Author: Manxhuka, Bardh ; Lindgren, Stefan C. ; Strid, Hans ; Nanu, Neesha ; Hjortswang, Henrik ; Pollock, Richard F.

OBJECTIVES:

Iron deficiency anemia (IDA) is a common extraintestinal manifestation of inflammatory bowel disease (IBD), driven by impaired iron absorption, inflammation of intestinal mucosa and blood loss due to intestinal bleeding. Exogenous iron is indicated to correct iron deficiency, with intravenous iron preferred in patients with malabsorption or intolerance of oral iron, active bleeding, systemic inflammation, or a need for rapid iron replenishment. The objective was to assess the cost-utility of two high-dose, rapid-infusion iron formulations-ferric derisomaltose (FDI) and ferric carboxymaltose (FCM)-in the treatment of patients with IBD and IDA in Sweden.

METHODS:

The analysis used a previously-published micro-simulation model. Phosphate monitoring was modeled based on the product labelling, while iron need and disease-related quality of life (QoL) were modeled based on data from the PHOSPHARE-IBD randomized controlled trial. Cost-utility was evaluated from the national healthcare payer perspective over a five-year time horizon. Sensitivity and scenario analyses were performed.

RESULTS:

For each iron treatment course, patients treated with FDI required 0.41 fewer infusions than those treated with FCM. The reduced number of infusions resulted in savings of SEK 9,876 over five years from iron administration costs alone (SEK 44,216 with FCM versus SEK 34,340 with FDI). Phosphate monitoring in patients treated with FCM cost SEK 2,776 over five years versus no monitoring costs with FDI. Total cost savings with FDI were SEK 14,962. FDI also resulted in a 0.076 quality-adjusted life year (QALY) improvement versus FCM driven primarily by the QoL improvements reported in PHOSPHARE-IBD, and FDI was therefore the dominant intervention.

LIMITATIONS:

The analysis did not capture costs or outcomes associated with hypophosphatemic osteomalacia or fractures.

CONCLUSION:

Relative to FCM, fewer infusions of FDI were required, there was no need for phosphate monitoring, and disease-related QoL was improved, while overall costs were reduced.

01 May 2025·HEART

Gaps in knowledge and management of iron deficiency in heart failure: a nationwide survey of cardiologists in China

Article

Author: Cleland, John G F ; Zheng, Zhaoqi ; Hu, Dan ; Zhao, Xuecheng ; Li, Zeng ; Meng, Zhen ; Liu, Jiang ; Wang, Xi ; Zhang, Yanqing ; Cao, Hong-Shuai ; Liu, Wanjun ; Su, Guangsheng ; Ren, Jingyi ; Li, Peizhao ; Su, Lina ; An, Hui ; Liu, Yujian ; Lai, Jinsheng ; Sun, Di ; Zhang, Hu ; Hao, Xiang ; Chen, Zhiping ; Bai, Ming ; Lamu, Gusang ; Zhou, Pei ; Li, Sufang ; Chen, Sizhen ; Wu, Manyan ; Feng, Lina ; Gong, Jingjing ; Sun, Lijie ; Cao, Lulei ; Su, Xiaoling ; Xu, Bihe ; Maimaiti, Ailifeire ; Lu, Zhan ; Zhang, Hao ; Zheng, Jingang ; Liu, Chuanfen ; Kang, Naidan ; Zhou, Ying ; Liu, Wenjie

Background:

Heart failure (HF) guidelines recommend routine testing for iron deficiency (ID) and, for those with ID, intravenous iron if the left ventricular ejection fraction is <50%. Guideline adherence to these recommendations by cardiologists in China is unknown.

Methods and results:

An independent academic web-based survey was designed and distributed via social networks to cardiologists across China. Overall, 1342 cardiologists (median age 34 years, IQR 30–39, 51% women) from all provinces of China completed this survey. More than half were unaware of the need to screen for ID in HF and did not do so routinely in their clinical practice. Approximately 80% were not familiar with the diagnostic criteria for ID in HF guidelines, and only 0.8% recognised transferrin saturation <20% as an independent marker of ID. Regarding iron repletion, only 14% preferred intravenous to oral iron for correcting ID compared with 68% favouring oral iron. Three-quarters were unfamiliar with methods for calculating intravenous iron dose. Furthermore, over 80% were unaware that current guidelines only recommend ferric carboxymaltose or ferric derisomaltose for correcting ID. The main barriers to using intravenous iron were lack of knowledge and experience. Despite such poor awareness and practice, most cardiologists were interested in learning more about managing ID in HF.

Conclusions:

In this nationwide survey of cardiologists in China, we identified large gaps in both knowledge and management of ID. This survey will help guide the development of educational programmes to improve care for patients with HF and ID in China.

News (Medical) associated with Ferric Carboxymaltose

02 Dec 2024

·www.drugs.com

Guidelines Developed for Treatment of Restless Legs Syndrome

MONDAY, Dec. 2, 2024 -- In a clinical practice guideline issued by the American Academy of Sleep Medicine and published online Sept. 26 in the Journal of Clinical Sleep Medicine , recommendations are presented for the treatment of restless legs syndrome (RLS). John W. Winkelman, M.D., Ph.D., from Massachusetts General Hospital in Boston, and colleagues developed recommendations for treatment of RLS and periodic limb movement disorder in adults and pediatric patients. The researchers developed three good practice statements that were based on expert consensus. They recommend all clinicians should regularly test serum iron studies, including ferritin and transferrin saturation, in all patients with clinically significant RLS, ideally in the morning; analysis of these studies influences the decision to use oral or intravenous (IV) iron treatment. The authors also state that addressing exacerbating factors, including alcohol, caffeine, antihistaminergic, serotonergic, and anti-dopaminergic medications, should be the first step in RLS management. They note RLS is common in pregnancy and the pregnancy-specific safety profile of each treatment should be considered. Recommendations for adults with RLS include use of gabapentin enacarbil over no gabapentin enacarbil; use of gabapentin over no gabapentin; use of pregabalin over no pregabalin; and use of IV ferric carboxymaltose over no IV ferric carboxymaltose for those with appropriate iron status (strong recommendations; moderate certainty of evidence). In addition, there is a strong recommendation against use of cabergoline. "Guided by the best evidence in the scientific literature, we've provided recommendations that will improve the ability of clinicians to provide patient-centered care for people who have RLS," Winkelman said in a statement. One author disclosed ties to the pharmaceutical and medical device industries. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

19 Mar 2024

·www.prnewswire.com

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

ST. GALLEN, SWITZERLAND, March 19, 2024 /PRNewswire/ -- CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III* 1 to improve exercise capacity.2 Ferinject has now received marketing authorization in 87 countries worldwide. Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4. "While iron deficiency and associated anemia are some of the most prevalent medical conditions on a global scale, it is easily diagnosed and treatable," said Prof. Dr. Justin Ezekowitz, Director of Cardiovascular Research and Cardiologist at the University of Alberta, Canada. "The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency." Iron deficiency affects one in every two hospitalized patients with heart failure5. Iron deficiency is often accompanied by reduced exercise tolerance and untreated iron deficiency may result in anemia and worsening NYHA class, with reduced quality of life and eventually increased risk of hospitalization 6,7,8 "The approval by Health Canada marks an important step forward for the treatment of iron deficiency anemia as well as iron deficiency in heart failure and supports our promise to patients and public health," said Dr. Vinicius Gomes de Lima, Head of Global Medical Affairs, CSL Vifor. "We are confident that our now approved IV iron therapy can make a meaningful contribution to achieve key therapeutic goals in the treatment of these patients." Marketing authorization in Canada is based on a comprehensive clinical data package and totality of evidence from CSL Vifor's cardiology studies. In Canada, Ferinject® is commercialized through CSL Behring Canada, Inc., with availability expected in the second half of 2024. * The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms. Patients who have a slight or marked limitation of their physical activity due to fatigue, palpitation and/or dyspnea are considered to have class II or class III heart failure, respectively.9 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor, visit . About Ferinject Ferinject (ferric carboxymaltose) is an IV iron therapy with marketing authorization in 87 countries as of March 2024. Ferinject has historically delivered significant value to patients and healthcare systems which is based on extensive clinical data and more than 25 million patient years of exposure10. In Canada, Ferinject is indicated for the treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and NYHA class II/III to improve exercise capacity. The diagnosis of iron deficiency must be based on laboratory tests.2 Important Information for Canada For more information and a complete risk/benefit profile, please refer to the Product Monograph available here. About iron deficiency and associated anemia Iron plays a vital role in many bodily processes, including the production of red blood cells, effective heart and brain function, and the prevention of infection and illness. Without enough iron, the body is unable to function properly. Common symptoms include fatigue, dizziness, and shortness of breath. Iron deficiency and iron deficiency anemia are estimated to affect one in three people worldwide11, yet despite the serious consequences and high prevalence12, the conditions remain under-recognized. The effects of iron deficiency differ from person to person but can be linked to an overall decline in general health and well-being13. Iron deficiency and iron deficiency anemia can be debilitating, exacerbate an underlying chronic disease and lead to increased morbidity and mortality13. Common symptoms include fatigue 13,14,15 pale skin14, brittle nails14, 16, craving non-food items such as dirt, clay and ice17, and an inability to concentrate13, 18. In children, iron deficiency anemia can significantly impair cognitive and motor development19,20,21. Multiple organizations, including the World Health Organization (WHO), UNICEF and the U.S. Agency for International Development (USAID) have called for a comprehensive anemia monitoring framework. Find more information on the global burden of anemia in the report published in the Lancet in July 2023: . References Fox AC, Gorlin R, Levin RI, New York Heart Association. Criteria Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994. Ferinject Product Monograph. CSL Vifor, St. Gallen, Switzerland. Chang V et al. J Nutr 2022 ; 153 : 781–797. doi.org/10.1016/j.tjnut.2022.10.011; Cochrane K et al. J Nutr 2022;152:2238–2244. Tahir E et al. 2020 Can J Public Health 111, 682–693 (2020). doi.org/10.17269/s41997-020-00304-7; Abdullah K et al Canadian Paediatric Surveillance program, 2011 . Del Pinto et al. Eur Heart J Suppl. 2022 Nov; 24(Suppl I): I96–I99). Ebner N, von Haehling S. Iron deficiency in heart failure: a practical guide. Nutrients. 2013;5(9):3730-9. doi:10.3390/nu5093730. Klip IT, Comin-Colet J, Voors A a, et al. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J. 2013;165(4):575-582.e3. doi:10.1016/j.ahj.2013.01.017. Guedes M NDT 2021. doi: 10.1093/ndt/gfab050; Enjuanes C, et al. Int J Cardiol. 2014;174(2):268–275. Classes of Heart Failure. American Heart Association. May 2017. Data on file. PSUR report. CSL Vifor, St. Gallen, Switzerland. Peyrin-Biroulet L, et al. Guidelines on the diagnosis and treatment of iron deficiency across indications: a systematic review. Am J Clin Nutr. 2015;102(6):1585-94. World Health Organization. Worldwide prevalence of anaemia 1993-2005. 2008. Available at URL: E0C7?sequence=1. Last accessed: November 2023. Fernando B, et al. A guide to diagnosis of iron deficiency and iron deficiency anemia in digestive diseases. World J Gastroenterol. 2009 Oct 7; 15(37): 4638-4643. Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016;91(1):31-38. Favrat, B., et al. (2014). Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women--PREFER a randomized, placebo-controlled study. PLoS One 9(4): e94217. eCollection 2014. Cashman MW, Sloan SB. Nutrition and nail disease. Clin Dermatol. 2010;28(4):420-5. Barton JC, et al. Pica associated with iron deficiency or depletion: clinical and laboratory correlates in 262 non-pregnant adult outpatients. BMC Blood Disord. 2010;10:9. doi:10.1186/1471-2326-10-9. Patterson A et al. Iron deficiency, general health and fatigue: Results from the Australian Longitudinal Study on Women's Health. Qual Life Res. 2000;9:491-497. World Health Organization. Nutritional anaemias: tools for effective prevention and control. 2017. Available at URL: . Last accessed: November 2023. Sant-Rayn S, et al. Diagnosis and management of iron deficiency anaemia: a clinical update. Med J Aust 2010; 193 (9): 525-532. doi: 10.5694/j.1326-5377.2010.tb04038.x. Özdemir N. Iron deficiency anemia from diagnosis to treatment in children. Turk Pediatri Ars. 2015 Mar 1;50(1):11-9. doi: 10.5152/tpa.2015.2337. PMID: 26078692; PMCID: PMC4462328. CSL Vifor Media Contact Thomas Hutter +41 79 957 96 73 [email protected] SOURCE Vifor International AG (CSL Vifor)

Drug ApprovalAHA

29 Jan 2024

·www.prnewswire.com

Renal Anemia Therapeutics Market to Record Growth of USD 2.08 billion from 2023 to 2028, Akebia Therapeutics Inc and Amgen Inc to emerge as Some of the Key Companies - Technavio

NEW YORK, Jan. 29, 2024 /PRNewswire/ -- The renal anemia therapeutics market is estimated to grow by USD 2.08 billion during 2023-2028, growing at a CAGR of 7.59%. Akebia Therapeutics Inc and Amgen Inc to emerge as some of the major companies. Akebia Therapeutics Inc offers adadustat. The report includes information on the product launches, sustainability, and prospects of leading companies including Akebia Therapeutics Inc., Amgen Inc., AstraZeneca Plc, Bayer AG, Covis Pharma GmbH, CSL Ltd., Daiichi Sankyo Co. Ltd., Dr Reddys Laboratories Ltd., F. Hoffmann La Roche Ltd., FibroGen Inc., GlaxoSmithKline Plc, Japan Tobacco Inc., JCR Pharmaceticals Co. Ltd., Kirin Holdings Co. Ltd., Mitsubishi Chemical Group Corp., Pfizer Inc., Pharmacosmos AS, Sun Pharmaceutical Industries Ltd., Travere Therapeutics Inc., and Astellas Pharma Inc.. For Comprehensive details on the market size of historic period(2018 to 2022) and forecast period (2024-2028) - View the Free Sample report Continue Reading Technavio has announced its latest market research report titled Global Renal Anemia Therapeutics Market 2024-2028 The market is fragmented; the companies are competing with competitors and are trying to get greater market share. The market is growing, and chances of new entrants cannot be overlooked. The major companies have well-established economies of scale and presence and generally rely on positioning, technological advances, and the price of the products - The report provides a full list of key companies, their strategies, and the latest developments. Buy Now The growing geriatric population drives the growth. The prevalence of chronic diseases like CKD, is high among the aging population. There is a direct relationship between aging and susceptibility to infections, as it deteriorates the immune system. Apart from the impaired functioning of the immune system, the reduced functioning of organs also increases the chances of acquiring diseases such as CKD. The growing adoption of biosimilars is an emerging trend shaping growth. Side effects of oral administration of renal anemia drugs is a major challenge hindering growth. Technavio has identified key trends, drivers, and challenges, which will help clients improve their strategies to stay ahead of their competitors. - View the Free Sample Report The report includes competitive analysis, a proprietary tool to analyze and evaluate the position of companies based on their industry position score andperformance score. The competitive scenario categorizes companies based on various performance indicators. Some of the factors considered include the financial performance of companies over the past few years, growth strategies, product innovations, new product launches, investments, and growth in market share, among others. Segmentation by Type The growth by the IV segment will be significant during the forecast period. The predominant segment is medications administered through the IV route, primarily attributed to the growing adoption and the convenience of absorption. Additionally, ferric carboxymaltose, sucrose, dextran, and other agents like ferumoxytol and isomaltoside contribute to this category. Gain instant access to 17,000+ research reports. Technavio's SUBSCRIPTION platform Applications The Renal Anemia Therapeutics Market is a dynamic landscape where medical interventions target conditions such as Chronic Kidney Disease (CKD) through a range of treatments. Erythropoiesis-Stimulating Agents (ESAs), including Darbepoetin Alfa and Epoetin Alfa, play a pivotal role in managing anemia associated with renal diseases. Innovative therapies like Roxadustat, a Hypoxia-Inducible Factor Prolyl Hydroxylase (HIF-PH) Inhibitor, showcase advancements in addressing anemia linked to CKD. Iron Supplements, both intravenous and oral, are essential components, alongside Ferric Citrate and Ferric Gluconate, contributing to comprehensive anemia management. The market encompasses diverse modalities, from Hemodialysis to Peritoneal Dialysis, recognizing the significance of tailored approaches. Related Reports The hormone replacement therapy (HRT) market size is estimated to grow by USD 8.44 billion, at a CAGR of 6.67% between 2023 and 2028. The equine supplement products market size is estimated to grow by USD 20,352.14 at a CAGR of 4.19% between 2023 and 2028. 1 Executive Summary 2 Landscape 3 Sizing 4 Historic Size 5 Five Forces Analysis 6 Segmentation by Type 7 Segmentation by Distribution Channel 8 Customer Landscape 9 Geographic Landscape 10 Drivers, Challenges, and Trends 11 Company Landscape 12 Company Analysis 13 Appendix About US Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging trends and provide actionable insights to help businesses identify opportunities and develop effective strategies to optimize their positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable insights to identify opportunities in existing and potential markets and assess their competitive positions within changing scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

100 Deals associated with Ferric Carboxymaltose

External Link

KEGG	Wiki	ATC	Drug Bank
D08920	Ferric Carboxymaltose	B03A	DB08917

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Iron deficiency	United States	American Regent, Inc.	31 May 2023
Anemia, Iron-Deficiency	European Union	Vifor SA	26 Jun 2007
Anemia, Iron-Deficiency	Iceland	Vifor SA	26 Jun 2007
Anemia, Iron-Deficiency	Liechtenstein	Vifor SA	26 Jun 2007
Anemia, Iron-Deficiency	Norway	Vifor SA	26 Jun 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure, Systolic	Phase 3	Brazil	Vifor Pharma AG	24 May 2024
Heart Failure	Phase 3	United States	American Regent, Inc.	15 Mar 2017
Heart Failure	Phase 3	Australia	American Regent, Inc.	15 Mar 2017
Heart Failure	Phase 3	Bulgaria	American Regent, Inc.	15 Mar 2017
Heart Failure	Phase 3	Canada	American Regent, Inc.	15 Mar 2017
Heart Failure	Phase 3	Czechia	American Regent, Inc.	15 Mar 2017
Heart Failure	Phase 3	Georgia	American Regent, Inc.	15 Mar 2017
Heart Failure	Phase 3	Hungary	American Regent, Inc.	15 Mar 2017
Heart Failure	Phase 3	Latvia	American Regent, Inc.	15 Mar 2017
Heart Failure	Phase 3	Lithuania	American Regent, Inc.	15 Mar 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00685815 (RLS, CTgov)	Phase 2	Restless Legs Syndrome	12	Ferric Carboxymaltose (FCM) (Ferric Carboxymaltose (FCM))	ibnlrfemea = ooepvpwsbl jthvppnrhe (abfhjxmtwi, cirdsetjyi - wjnxbluhkl) View more	-	06 May 2025
				Placebo (Placebo)	ibnlrfemea = aumexmwoth jthvppnrhe (abfhjxmtwi, pasahrikbn - hsturrotua) View more
NCT00740246 (CTgov)	Phase 3	Anemia, Iron-Deficiency	594	ViT-45 (ViT-45)	vcqffglqiy = bkazgshxrm ldieidwgkk (epqhddivsj, dszsvvljby - xjttwnsoeu)	-	18 Apr 2025
				Placebo (Placebo)	vcqffglqiy = kbsanvsjxc ldieidwgkk (epqhddivsj, mpduaoryub - fvkrrtyhoa)
NCT01692418 (PREVENTT, Literature) Manual	Phase 3	Anemia	392	ferric carboxymaltose	lhlvkqgqwh(luzzlgizsk) = srzneynwtm vfdbxmfvbf (yljbaeeupj ) View more	Positive	17 Apr 2025
				Placebo	lhlvkqgqwh(luzzlgizsk) = dpizydrkpb vfdbxmfvbf (yljbaeeupj ) View more
UEGW2024	Not Applicable	Anemia, Iron-Deficiency	-	Ferric carboxymaltose (FCM)	heraqbalck(msopostrht) = One patient reported mild side effects (pruritus, cutaneous erythema) not requiring FCM interruption and reversing after H 2 antagonist treatment within 15 minutes qbqkkjfmzo (npxckytdnu )	-	13 Oct 2024
NCT03037931 (HEART-FID, CTgov)	Phase 3	Iron deficiency \| Heart Failure	3,065	Ferric Carboxymaltose (Ferric Carboxymaltose)	zsvnlzziyj = flkmcevmtw cdlduokqsa (hexmkwonwn, retkvdkcpx - gdgiuxetva) View more	-	03 Jul 2024
				Placebo (Placebo)	zsvnlzziyj = dgpbjlexge cdlduokqsa (hexmkwonwn, ilubrarmuu - edcnppbzcs) View more
EHA2024	Not Applicable	Anemia, Iron-Deficiency	-	Ferric Carboxymaltose	ktcpyqrzbi(jlkxugudin): RR = 2.75 (95% CI, 2.29 - 3.3), P-Value = <0.0001 View more	Negative	14 May 2024
				Iron Sucrose
NCT01690585 (Pubmed \| Age Ageing) Manual	Phase 3	Gastrointestinal Hemorrhage	59	Ferric carboxymaltose	pmckukorko(twwiaqzbcj) = agbyywrhgc plqolrvaie (smvlpxmfqm ) View more	Positive	01 May 2024
				Placebo	pmckukorko(twwiaqzbcj) = vprvriclsm plqolrvaie (smvlpxmfqm ) View more
ASH2023	Not Applicable	-	289	Ferric Carboxymaltose (FCM)	teufwqcdcc(hztlhcnvan) = nrnivnwosn newmcenhik (hvqqwziscl )	-	11 Dec 2023
				Ferric Derisomaltose (FDI)	teufwqcdcc(hztlhcnvan) = yajekqimdr newmcenhik (hvqqwziscl )
SOHO2023	Not Applicable	-	-	Ferric Carboxymaltose (FCM)	mxxogwtiuj(weuuiuzpft): risk ratio = 0.97 (95% CI, 0.62 - 1.51), P-Value = 0.86 View more	-	01 Sep 2023
				Iron Sucrose (IS)
ESC2023	Not Applicable	-	101	Ferric carboxymaltose	udjurupdfy(ulaujuzmtz) = chbtqhywpz yvuvduzfbl (rjyxcrisrg )	-	28 Aug 2023

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