This study aims to determine the effect of online education structured according to Pender's Health Promotion Model on symptom burden, medication adherence, and nutritional behaviour in patients with heart failure. The sample size was calculated using the 'G. Power-3.1.9.2' programme at a 95% confidence level prior to data collection. Accordingly, the minimum sample size required for the independent sample t-test for the study was determined to be 44 (22 for each group) based on an alpha value of 0.05, an effect size of 1.128, and a theoretical power of 95%. Taking data losses into account, a total of 60 patients (30 for each group) were planned to be included in the sample. Data will be collected using the Heart Failure Symptom Status Scale, Medication Adherence and Prescription Printing Scale (İURYÖ-7), Heart Failure Nutrition Behaviour Scale. 1: Prior to providing education to patients, they will be informed about the purpose of the study, the data collection method, and the topics to be covered in the education. Patients who agree to participate in the study will be asked to sign an informed consent form. All patients in the experimental and control groups will be asked to complete the Heart Failure Nutrition Behaviour Scale (HFNBS), Heart Failure Symptom Status Scale (HFSSS), and Medication Adherence and Prescription Writing Scale (MAPWS-79) before receiving education.
2: The contact information of all patients in the experimental group will be collected. Training will be provided online at a time and date convenient for the patients.
3: Patients in the control group will receive a digital training booklet prepared by the researcher at the contact address they provide.
4: Participants will be contacted 2 weeks, 1 month, and 2 months after the initial education session to obtain feedback on post-education dietary behaviours, medication adherence, and symptoms.
5: Four to six weeks after the training is completed, the 'Nutritional Behaviour Scale in Heart Failure,' 'Heart Failure Symptom Status Scale,' and 'Medication Adherence and Prescription Writing Scale (İURYÖ-7)' will be completed online again. The same forms will also be completed online by patients in the control group 4-6 weeks later.

Start Date15 Jul 2025

Sponsor / Collaborator

Canakkale Onsekiz Mart University

NCT07057973

/ RecruitingNot ApplicableIIT

The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly

Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.

Start Date01 Jul 2025

Sponsor / Collaborator

Xuanwu Hospital Capital Medical University

CTRI/2025/06/088448

/ Not yet recruitingNot Applicable

A Double Blind Balanced Randomized Single Dose Two Treatment Parallel Truncated Bioequivalence Study Comparing Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL by Jodas Expoim Private Limited Telangana Manufactured For Nova Pharmaceuticals Australasia Pty Ltd With Ferinject Injection Ferric Carboxymaltose 1000mg per 20mL Manufactured by Vifor Pharma Pty Ltd Level 8 80 Dorcas Street Southbank Melbourne Vic 3006 Australia in Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions - NIL

Start Date26 Jun 2025

Sponsor / Collaborator

Nova Pharmaceuticals Australasia Pty Ltd.

100 Clinical Results associated with Ferric Carboxymaltose

100 Translational Medicine associated with Ferric Carboxymaltose

100 Patents (Medical) associated with Ferric Carboxymaltose

865

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. ; Pollock, R. F. ; Nanu, N. ; 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 Aug 2025·EJHaem

Cutaneous Reactions to Iron Infusions: A Case Report and Clinical Review

Article

Author: Ravichandran, Sairekha ; Patil, Neil ; Kubal, Timothy ; Kirtane, Kedar ; Phuoc, Vania ; Messina, Jane ; Maharaj, Satish

ABSTRACT:

Anemia is prevalent globally and often treated with intravenous (IV) iron formulations, including iron sucrose, iron dextran, ferric carboxymaltose, ferric derisomaltose, and ferumoxytol. IV iron has a high efficacy and safety profile, quickly improving hemoglobin levels with low rates of adverse events. In this work, we report an uncommon case of a cutaneous hypersensitivity reaction following IV iron. A review of the literature shows that acute and delayed cutaneous reactions are possible but rare and respond well to management. Patients should be educated, and staff should be vigilant as to these cutaneous reactions.Clinical Trial Registration:The authors have confirmed that clinical trial registration is not needed for this submission.

News (Medical) associated with Ferric Carboxymaltose

11 Aug 2025

·www.prnewswire.com

Viatris Announces Approval of First Generic Iron Sucrose Injection in the U.S.

Approval is Another Milestone of Viatris' Ability to Successfully Develop Complex Generic Medicines Approval Granted with Competitive Generic Therapy Eligibility for 100mg/5mL and 200mg/10mL Strengths; Provides Eligibility for 180 Days of Exclusivity PITTSBURGH, Aug. 11, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced the U.S. Food and Drug Administration (FDA) has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric patients (2 years of age and older) with chronic kidney disease (CKD). IDA is a common complication of CKD and is associated with a significantly heightened risk of cardiovascular morbidity and higher mortality rates. Iron Sucrose Injection, USP, the first generic version of Venofer® Injection, is expected to be available imminently in single dose vials in the following strengths: 50 mg/2.5mL, 100mg/5mL and 200mg/10mL. Viatris Chief R&D Officer Philippe Martin said, "The first FDA approval of a generic iron sucrose is an important advancement for patients with CKD and iron deficiency anemia and a testament to Viatris' advanced technical and manufacturing capabilities. This complex product was developed in-house, and after a number of years working closely with the FDA we are pleased to accomplish this important milestone." Viatris' robust complex injectable pipeline includes multiple difficult-to-develop and manufacture assets across several therapeutic areas and patient types. The pipeline also includes ferric carboxymaltose injection – another iron replacement product. Viatris Chief Commercial Officer Corinne Le Goff said, "The U.S. launch of this first-to-market generic iron sucrose will be an important addition to the treatment landscape for chronic kidney disease patients with iron deficiency, and will help increase sustainable access to this critical therapy. Iron sucrose builds on Viatris' large and diversified global business and will further strengthen our generics portfolio." The FDA granted Viatris a competitive generic therapy (CGT) designation for iron sucrose 100 mg/5 mL and 200 mg/10 mL strengths. CGT designation allows for expedited review of generic versions of medications with "inadequate generic competition." This regulatory pathway helps to expedite market entry of generic drugs and provides eligibility for 180 days of exclusivity upon commercial marketing of the medicine. Venofer® had annual sales of approximately $515M in the U.S. as of June 30, 2025, according to IQVIA. Iron Sucrose Injection, For Intravenous Use INDICATION AND USAGE Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to iron sucrose. WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving iron sucrose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop iron sucrose immediately. Monitor patients for signs and symptoms of hypersensitivity during and after iron sucrose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer iron sucrose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion. Hypotension: Iron sucrose may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of iron sucrose. Hypotension following administration of iron sucrose may be related to rate of administration and/or total dose delivered. Iron overload: Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving iron sucrose require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin, and transferrin saturation). Do not administer iron sucrose to patients with evidence of iron overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing. ADVERSE REACTIONS Adult Patients: The most common adverse reactions (≥2%) include diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. Pediatric Patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension. Post-Marketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In post-marketing safety studies of iron sucrose in 1,051 patients with HDD-CKD, adverse reactions reported by >1% were cardiac failure congestive, sepsis, and dysgeusia. Immune system disorders: anaphylactic-type reactions, angioedema Psychiatric disorders: confusion Nervous system disorders: convulsions, collapse, light-headedness, loss-of-consciousness Cardiovascular system: bradycardia, shock, acute myocardial ischemia with or without myocardial infarction or with in-stent thrombosis in the context of a hypersensitivity reaction Respiratory, thoracic, and mediastinal disorders: bronchospasm, dyspnea Musculoskeletal and connective tissue disorders: back pain, swelling of the joints Renal and urinary disorders: chromaturia General disorders and administration site conditions: hyperhidrosis Symptoms associated with iron sucrose total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of iron sucrose injection. Reactions have occurred following the first dose or subsequent doses of iron sucrose. Slowing the infusion rate may alleviate symptoms. Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation. DRUG INTERACTIONS Iron sucrose may reduce the absorption of concomitantly administered oral iron preparations. USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary-Clinical Considerations Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as iron sucrose) which may cause fetal bradycardia, especially during the second and third trimester. Geriatric Use Dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. For additional Safety Information, please see Full Prescribing Information. About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com , and connect with us on LinkedIn , Instagram , YouTube and X . Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that approval is another milestone of Viatris' ability to successfully develop complex generic medicines; approval granted with competitive generic therapy eligibility for 100mg/5mL and 200mg/10mL strengths; provides 180 days of exclusivity; Iron Sucrose Injection, USP, the first generic version of Venofer® Injection, is expected to be available imminently available in single dose vials in the following strengths: 50 mg/2.5mL, 100mg/5mL and 200mg/10mL; the first FDA approval of a generic iron sucrose is an important advancement for patients with CKD and iron deficiency anemia and a testament to Viatris' advanced technical and manufacturing capabilities; the U.S. launch of this first-to-market generic iron sucrose will be an important addition to the treatment landscape for chronic kidney disease patients with iron deficiency, and will help increase sustainable access to this critical therapy; iron sucrose builds on Viatris' large and diversified global business and will further strengthen our generics portfolio. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: whether any other companies have simultaneously launched a generic iron sucrose injection in the U.S. and have shared exclusivity for the first 180 days; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalBreakthrough Therapy

11 Aug 2025

·firstwordpharma.com

First generic of Daiichi's Venofer approved in US

The FDA has approved the first generic version of Daiichi Sankyo's Venofer, clearing Viatris to market its iron sucrose injection for the treatment of iron deficiency anaemia in adults and children two years and older with chronic kidney disease (CKDThe FDA has approved the first generic version of Daiichi Sankyo's Venofer, clearing Viatris to market its iron sucrose injection for the treatment of iron deficiency anaemia in adults and children two years and older with chronic kidney disease (CKDThe FDA has approved the first generic version of Daiichi Sankyo's Venofer, clearing Viatris to market its iron sucrose injection for the treatment of iron deficiency anaemia in adults and children two years and older with chronic kidney disease (CKD).The FDA has approved the first generic version of Daiichi Sankyo's Venofer, clearing Viatris to market its iron sucrose injection for the treatment of iron deficiency anaemia in adults and children two years and older with chronic kidney disease (CKD).The FDA has approved the first generic version of Daiichi Sankyo's Venofer, clearing Viatris to market its iron sucrose injection for the treatment of iron deficiency anaemia in adults and children two years and older with chronic kidney disease (CKD)."This complex product was developed in-house…after a number of years working closely with the FDA," said Philippe Martin, chief R&D officer, in a release Monday. Iron deficiency anaemia is a common complication of CKD and is linked to significantly higher cardiovascular morbidity and higher mortality.Venofer, which Daiichi markets in the US under a license from Vifor, generated sales of about JPY 62 billion ($419 million) during the 2024 Japanese fiscal year. Viatris expects its product to be available "imminently." Chief Commercial Officer Corinne Le Goff said the launch would be "an important addition to the treatment landscape for chronic kidney disease patients with iron deficiency, and will help increase sustainable access to this critical therapy." Limited availability of Venofer in the US reported over the last year appears to have been resolved, according to the website of the American Society of Health-System Pharmacists, which tracks drug shortages in the country.Meanwhile, the FDA also granted the 100- and 200-mg dose strengths of Viatris' treatment a competitive generic therapy designation, allowing it to launch its product with 180 days of market exclusivity.The company says the approval adds to its complex injectable pipeline, which includes other iron replacement products such as ferric carboxymaltose injection.

Drug Approval

29 May 2025

·www.sciencedaily.com

Unlocking precise composition analysis of nanomedicines

Current regulations for nanomedicines overlook the effects of the different forms of the same element, such as ions, nanoparticles, and aggregates. In a recent study, researchers developed a new analytical method combining an asymmetric flow field-flow fractionation system and mass spectrometry to separately quantify these forms. This technique allows for better quality control and safety evaluation of metal-based nanomedicines, promoting their development and clinical use, with applications also extending to food, cosmetics, and the environment. Current regulations for nanomedicines overlook the effects of the different forms of the same element, such as ions, nanoparticles, and aggregates. In a recent study, Japanese researchers developed a new analytical method combining an asymmetric flow field-flow fractionation system and mass spectrometry to separately quantify these forms. This technique allows for better quality control and safety evaluation of metal-based nanomedicines, promoting their development and clinical use, with applications also extending to food, cosmetics, and the environment. Nanomedicines, especially those based on nanoparticles, are revolutionizing healthcare in terms of both diagnostics and therapeutics. These particles, often containing metals like iron or gold, can serve as contrast agents in medical imaging, act as nutritional supplements, and even function as carriers for drug delivery. Thanks to their unique properties plus careful engineering, nanomedicines can reach and accumulate in places within the body that conventional medicines cannot, making them promising for cancer detection and treatment. However, the same characteristics that make nanomedicines valuable also present challenges in ensuring their safety and quality. Current pharmaceutical guidelines, including those from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), have a significant blind spot: they evaluate only the total amount of elements present in a medication without distinguishing between their different forms, such as ions or differently sized particles. This distinction is crucial because these different forms can have different effects on the body, including varying toxicity pro Against this backdrop, a research team led by Assistant Professor Yu-ki Tanaka from the Graduate School of Pharmaceutical Sciences, Chiba University, Japan, has developed a new analytical method to address the existing regulatory gap. Their study, which was made available online in the journal Talanta on April 8, 2025, introduces a technique to separately quantify ions, nanoparticles, and aggregated particles in nanomedicines. Co-authored by Yasumitsu Ogra and Sana Hasegawa, also from Chiba University, the study showcases how this method can improve quality control for these advanced pharmaceutical products. "By incorporating a novel evaluation method that addresses a previously overlooked issue in current evaluation guidelines, we can ensure the safe use of metal-based nanomedicines such as Resovist® and Ferinject®" explains Dr. Tanaka. The researchers combined two existing technologies -- asymmetric flow field-flow fractionation (AF4) and inductively coupled plasma mass spectrometry (ICP-MS). They used the AF4 method in a novel way, taking advantage of its initial 'focus step.' During this step, particles are held inside the AF4 channel by two opposing flows. Using a special permeable membrane, cross-flows filter out the tiniest dissolved particles (ions), enabling quantification based on the differences in ICP-MS signals between samples with and without ion removal−namely, with and without the focus step. Once the ions are separated, the system then uses AF4's standard separation process to sort the retained nanoparticles by size. Finally, the ICP-MS device attached to the output can determine the approximate number of nanoparticles of each size. This combination enabled the team to distinguish between free metal ions, small hydroxide colloids, and nanoparticles of various sizes, all containing the same metal element. They tested their approach on Resovist®, a nanomedicine used as a contrast agent in liver magnetic resonance imaging scans. The analysis revealed that only 0.022% of the iron in Resovist® was present in ionic form. At approximately 6.3 micrograms per milliliter, this negligible amount falls well below levels of concern. Additionally, the team confirmed that the active nanoparticles were smaller than 30 nanometers in diameter, with some aggregates around 50 nanometers. Importantly, no large aggregates were detected, which could reduce the effectiveness of the contrast agent. These results confirm both the safety and stability of Resovist® as a nanomedicine. The proposed technique is particularly relevant for emerging cancer treatments that use gold nanoparticles as drug delivery systems or metallic particles for photothermal therapy. These advanced treatments rely on the 'enhanced permeability and retention (EPR) effect,' by which nanoparticles leak from blood vessels around tumors and accumulate in cancerous tissue. "Since many novel nanomedicines consist of metal-based nanoparticles as their active ingredients, providing reliable methods for evaluating their safety and quality control will promote their development and clinical use," notes Dr. Tanaka. Additionally, this novel analytical approach extends beyond pharmaceuticals. It can also assess the safety of metal nanoparticles in food additives, cosmetics, and environmental samples -- helping to ensure public health across multiple sectors. The researchers showcased its versatility by successfully analyzing both negatively charged ions (silicon) and positively charged ions (iron), indicating its potential for a wide range of nanomaterials. Overall, by offering a more comprehensive assessment of the composition, quality, and stability of nanoparticles, this research paves the way for safer and more effective nanomedicines and nanoparticle-based technologies.

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.

to view more data

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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure, Systolic	Phase 3	Brazil	Corden Pharma Fribourg SA	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


NCT01950247 (CTgov)	Phase 4	Anemia, Iron-Deficiency	1,025	Injectafer (Injectafer)	kyjaszysag(pnxnvzuksm) = adqxuuprsy ondfinxevj (okotwghqva, 11.38) View more	-	22 May 2025
				SOC (IV Iron Standard of Care (SOC))	kyjaszysag(pnxnvzuksm) = xnabgjautl ondfinxevj (okotwghqva, 11.28) View more
NCT00685815 (RLS, CTgov)	Phase 2	Restless Legs Syndrome	12	Ferric Carboxymaltose (FCM) (Ferric Carboxymaltose (FCM))	rwhlbofjai = ddkqdxqlga fwewzociun (qgyppdywoq, vvxjrbaqrz - haeyvzeyli) View more	-	06 May 2025
				Placebo (Placebo)	rwhlbofjai = zkaevbftzk fwewzociun (qgyppdywoq, hezqrwfcbw - recwtcokwi) View more
NCT00740246 (CTgov)	Phase 3	Anemia, Iron-Deficiency	594	ViT-45 (ViT-45)	dgutoryefr = guovaimiwl xtjwoqorvi (dudkpcaxpj, cpqcufounj - tldshznrdn)	-	18 Apr 2025
				Placebo (Placebo)	dgutoryefr = umlykxirpo xtjwoqorvi (dudkpcaxpj, phjqeefjmq - brfaqhttth)
NCT01692418 (PREVENTT, Literature) Manual	Phase 3	Anemia	392	ferric carboxymaltose	sbmjlhckdy(bwzbrxnfek) = fuevaszrwm spaekvuebc (tlweaipksz ) View more	Positive	17 Apr 2025
				Placebo	sbmjlhckdy(bwzbrxnfek) = swgnnlpvjk spaekvuebc (tlweaipksz ) View more
NCT03037931 (HEART-FID, CTgov)	Phase 3	Iron deficiency \| Heart Failure	3,065	Ferric Carboxymaltose (Ferric Carboxymaltose)	swhmknffmk = btsfazjgtc hwxwebxbmf (rfwaqqqsip, immyneivdm - mowhdhbuvn) View more	-	03 Jul 2024
				Placebo (Placebo)	swhmknffmk = tldnucohox hwxwebxbmf (rfwaqqqsip, meicvvqgqd - qhstebohno) View more
NCT01690585 (Pubmed \| Age Ageing) Manual	Phase 3	Gastrointestinal Hemorrhage	59	Ferric carboxymaltose	jdturdnbtx(mhtkbazwkb) = cnpboumsoj lrpptprsfa (tmtutivors ) View more	Positive	01 May 2024
				Placebo	jdturdnbtx(mhtkbazwkb) = zfvaekytuc lrpptprsfa (tmtutivors ) View more
ASH2023	Not Applicable	-	289	Ferric Carboxymaltose (FCM)	dkodhqyzzk(whncwutgvs) = bvowlptpub hbhvcgljol (veeorsabof )	-	11 Dec 2023
				Ferric Derisomaltose (FDI)	dkodhqyzzk(whncwutgvs) = iugehimtba hbhvcgljol (veeorsabof )
NCT03037931 (HEART-FID, Pubmed \| N Engl J Med)	Phase 3	Iron deficiency \| Heart Failure	3,065	Ferric carboxymaltose	eknfduzffs(xdkjdeipoy) = ovstlvcekh jcgsxokeaa (ofeoumiipa )	-	26 Aug 2023
				Placebo	eknfduzffs(xdkjdeipoy) = jcsflexpfh jcgsxokeaa (ofeoumiipa )
NCT03037931 (HEART-FID, Pubmed \| Am Heart J)	Not Applicable	Iron deficiency \| Heart Failure	3,065	Ferric Carboxymaltose	iujfkcedtq(gxanfssvon) = ltopwfwcbo sgoixrczmh (kjdyebyftj, 196 - 350) View more	-	18 Aug 2023
NCT03218384 (CTgov)	Phase 2	Heart failure NYHA class III \| Iron deficiency \| Heart Failure	20	31P MRS/MRI+Ferric Carboxymaltose (Ferric Carboxymaltose)	lybogbcpvk(wfatrlikkh) = mlblvuilhc endrvgnyrs (vifriwkgem, 4.66) View more	-	05 Jul 2023
				31P MRS/MRI (Placebo)	lybogbcpvk(wfatrlikkh) = ynkwunjkww endrvgnyrs (vifriwkgem, 49.27) View more

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Ferric Carboxymaltose

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