Phase IV, open-label, randomized clinical trial on the effect of intravenous iron on quality of life in elderly patients with Acute Coronary Syndrome.

Start Date27 Feb 2026

Sponsor / Collaborator-

NCT07414199

/ Not yet recruitingPhase 4

The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department

The goal of this project is to assess the feasibility, clinical effectiveness, and cost-effectiveness of IV iron therapy using ferric carboxymaltose (FCM) as a treatment for pediatric patients with iron deficiency anemia (IDA) in the emergency department (ED).
The primary objectives are to:
1. examine and compare healthcare utilization and clinical outcomes of IV FCM use in the pediatric ED compared to historical cohort.
2. determine the feasibility of IV FCM in the pediatric ED.
A secondary objective of this study is to evaluate if additional laboratory markers such as soluble transferrin receptor (sTfR) or reticulocyte hemoglobin equivalent can serve as potential surrogate markers for diagnosing and monitoring treatment response of IDA between oral iron and IV FCM.
By evaluating clinical outcomes such as the time to resolution of anemia, hospitalization rates and need for PRBC transfusion, assessing the feasibility of FCM implementation, and secondarily exploring potential adjunct markers for monitoring IDA, this study aims to fill the current research gap and potentially revolutionize management of IDA in pediatric emergency care.

Start Date31 Jan 2026

Sponsor / Collaborator

Children's Hospital of Orange County

NCT07359599

/ Not yet recruitingPhase 4IIT

A Randomized, Double-blind, Placebo-controlled, Multicentre Trial, Assessing the Impact of Ferric Carboxymaltose on Exercise Capacity and Functional Status in Pulmonary Hypertension

Pulmonary hypertension (PH) is a condition characterized by elevated blood pressure in the pulmonary arteries. This leads to symptoms such as shortness of breath and a significantly reduced exercise capacity, resulting in a very poor quality of life. Currently, treatment options for PH are limited.
More than 60% of patients with PH develop iron deficiency. Studies have shown that this deficiency is associated with more severe symptoms, reduced exercise capacity, and even lower quality of life. Oral iron supplements are often ineffective in these patients due to impaired absorption in the intestines, caused by chronic low-grade inflammation-a common feature in PH.
Intravenous iron administration can rapidly correct the deficiency, but it remains unclear whether this also leads to clinical improvements such as enhanced exercise capacity, reduced shortness of breath, and improved quality of life. Moreover, the cost-effectiveness of this treatment is still unknown. The IRON-PH study aims to answer these questions.
As part of the IRON-PH study, 306 patients with pulmonary hypertension will be enrolled. Each patient will be randomized to receive either intravenous iron (ferric carboxymaltose) or intravenous placebo (NaCl 0.9%).

Start Date27 Jan 2026

Sponsor / Collaborator

Ziekenhuis Oost-Limburg, Autonome Verzorgingsinstelling

100 Clinical Results associated with Ferric Carboxymaltose

100 Translational Medicine associated with Ferric Carboxymaltose

100 Patents (Medical) associated with Ferric Carboxymaltose

847

Literatures (Medical) associated with Ferric Carboxymaltose

01 Apr 2026·Anaesthesia Critical Care & Pain Medicine

Effect of Preoperative Intravenous Ferric Carboxymaltose on Postoperative Transfusion Reduction in Iron Deficiency Anemia Patients Scheduled for Clipping Surgery for Unruptured Intracranial Aneurysms: The PICASA Trial — A Single Center, Single-Blind Randomized Clinical Trial

Article

Author: Lim, Sungdae ; Kwon, O-Ki ; Ban, Seung Pil ; Lee, Sang Hyo ; Choi, Tae Won ; Bang, Jae Seung ; Koo, Chang-Hoon ; Lee, Si Un ; Kim, Young Deok ; Sung, Seung Bin

OBJECTIVE:

This study aimed to evaluate the efficacy of preoperative ferric carboxymaltose (FCM) in reducing red blood cell transfusion (RBCT) in patients with iron deficiency anemia (IDA) undergoing microsurgical clipping of unruptured intracranial aneurysms (UIAs).

BACKGROUND:

The impact of correcting preoperative anemia, a known predictor of RBCT, has been understudied in neurosurgical procedures.

METHODS:

This single-blind, randomized controlled trial (RCT) included patients with IDA scheduled for microsurgical clipping of UIAs. Participants were randomized to receive either preoperative FCM, administered as intravenous FCM 4 weeks before surgery, or standard care without intervention (control group). The primary outcome was the incidence of RBCT. Secondary outcomes included postoperative clinical outcomes, adverse events related to FCM, and changes in hemoglobin (Hb), serum iron, ferritin, and transferrin saturation.

RESULTS:

A total of 31 patients were randomized (17 in the FCM group and 14 in the control group). In the FCM group, Hb levels increased significantly by the day before surgery (p = 0.023), and no patients required RBCT, compared to 57.1% of patients in the control group (p < 0.001). Multivariate analysis identified FCM administration as the only independent factor significantly associated with reduced RBCT (OR 0.03, 95% CI 0-0.28, p < 0.001). In the inter-group analysis, Hb (p = 0.011) and ferritin (p < 0.001) levels were significantly higher in the FCM group throughout the observation period. No FCM-related adverse events were reported.

CONCLUSION:

Preoperative FCM administration significantly reduced the need for perioperative RBCT and improved anemia-related biomarkers in patients with IDA undergoing clipping for UIAs, with no adverse events reported.

REGISTRATION:

Clinical Trials under ID NCT04616092.

01 Feb 2026·MAYO CLINIC PROCEEDINGS

Safety of Ferric Carboxymaltose in Heart Failure Patients With Iron Deficiency Across Ferritin Levels, Heart Failure Causes, and Prior Hospitalization Status: A Meta-Analysis

Article

Author: Elazab, Ahmed ; Abdelazeem, Basel ; Elbenawi, Hossam ; Ali, Ahmed Hamdy G ; Abdelaziz, Ahmed ; Lavie, Carl J ; Elbataa, Ahmed ; Mansour, Ahmed

01 Feb 2026·European Journal of Obstetrics & Gynecology and Reproductive Biology

Ferric carboxymaltose for third-trimester refractory anemia and perinatal outcomes: Retrospective cohort analysis

Article

Author: Coşkun, Ayhan ; Atay, Hatice Banu ; Karaca, Sefanur Gamze ; Yıldız, Hamza ; Kıllı, Mürşide Çevikoğlu ; Dal, Yusuf ; Karagün, Şebnem

BACKGROUND:

Iron deficiency anemia (IDA) in the third trimester is associated with adverse perinatal outcomes, but data on intravenous ferric carboxymaltose (FCM) effects beyond hematologic response remain limited.

METHODS:

This retrospective cohort study, conducted at Mersin University Hospital (January 2019 - March 2024), included 311 pregnant women diagnosed with IDA in the third trimester who were clinically recommended FCM therapy due to inadequate response to oral ferrous sulfate. Among these, 206 accepted FCM treatment (in addition to continued oral iron) while 105 declined and received oral iron alone. Women were compared as two groups: those who received oral iron alone versus those who received oral iron plus a single-dose FCM in the third trimester,. At four timepoints (baseline, post-FCM, delivery, and postpartum), hemoglobin (Hgb), hematocrit, MCV, and MCHC levels were evaluated. The primary outcome was maternal perinatal hemoglobin response, while the secondary outcome was the investigation of its correlation with key neonatal outcomes following FCM administration. Repeated measures ANOVA, two-way ANOVA, and correlation analyses were used.

RESULTS:

The FCM group showed significantly higher Hgb levels at baseline, delivery, and postpartum (all p < 0.05). Birth weight (3164 ± 564 g vs. 2952 ± 691 g, p = 0.007), umblical cord blood pH (7.34 ± 0.04 vs. 7.28 ± 0.03, p < 0.001), and Apgar scores were also improved in the FCM group. Neonatal intensive care unit (NICU) admission was significantly reduced (20.9 % vs. 31.4 %, p = 0.041), as was the incidence of fetal growth restriction (16.5 % vs. 38.1 %, p < 0.001). In the FCM group, changes in Hgb from post-FCM to postpartum were positively correlated with 1-minute Apgar scores (r = 0.177, p = 0.011). Neonates requiring NICU admission showed an attenuated rise in Hgb across the same interval (p = 0.041), and women with adverse composite outcomes had greater Hgb fluctuation, particularly from delivery to postpartum (p = 0.020).

CONCLUSION:

Third-trimester FCM therapy leads to superior hematologic correction and improved neonatal outcomes compared to oral iron alone. Hemoglobin recovery patterns after FCM may be predictive of neonatal adaptation and adverse outcomes, highlighting the broader perinatal significance of timely parenteral iron therapy in late pregnancy.

News (Medical) associated with Ferric Carboxymaltose

01 Oct 2025

·www.fiercepharma.com

Sanofi's German, French premises hit by EU probe amid vaccines market abuse concerns

The European Commission is “investigating possible exclusionary practices that may amount to anticompetitive disparagement.” The EU has carried out unannounced inspections at certain Sanofi premises related to concerns that the French pharma may have abused its market position in the vaccines sector, Fierce Pharma has learned.The European Commission—the EU's executive arm—announced in a statement Monday that it conducted inspections at the premises of a company “active in the vaccines sector” in relation to “concerns that the inspected company may have violated EU antitrust rules that prohibit abuses of a dominant market position.” At the time, the commission wouldn't reveal the identity of the company nor the location of the premises, only explaining that it was “investigating possible exclusionary practices that may amount to anticompetitive disparagement.”However, a Sanofi spokesperson confirmed to Fierce Wednesday morning that it is the company at the center of the investigation. The inspections took place at Sanofi sites in France and Germany on Monday, according to the Big Pharma, which added that the visits were related to “an investigation into conduct in the seasonal flu vaccine space.” “Sanofi is confident that it is compliant with the relevant rules and regulations,” the spokesperson added. “Sanofi will not comment further given the ongoing investigation and will cooperate fully with the European Commission.”The Paris-based pharma is a major flu vaccine player, selling several products in Europe including Vaxigrip, Supemtek Tetra and Efluelda. Details of the alleged market abuse have not been revealed by the commission or Sanofi. This is typically a busy time for all vaccine drugmakers, with most beginning to ship out their products in the summer along with a marketing push as we look ahead to flu season, which can begin in early autumn and continue on until spring.Sanofi’s chief competitors in this space include CSL Seqirus and GSK.Last year, Vifor was also under the shadow of a European Commission probe for alleged antitrust abuse surrounding its “potential disparagement” of Pharmacosmos’ high-dose intravenous iron replacement therapy Monofer. The drug is a competitor to Vifor’s flagship iron medicine, Ferinject, in Europe.In the end, Vifor cleared up the probe last year with a “comprehensive and multi-channel communication campaign” to address the alleged anticompetitive actions.

Vaccine

04 Sep 2025

·www.prnewswire.com

Late Breaking Clinical Research Coming to Heart Failure Society of America Annual Scientific Meeting September 26-29

WASHINGTON, Sept. 4, 2025 /PRNewswire/ -- The Heart Failure Society of America (HFSA) is pleased to announce the Late Breaking Clinical Research that will be presented at its Annual Scientific Meeting (ASM), September 26-29, at the at the Minneapolis Convention Center in Minneapolis, MN. Late breaking clinical research to be featured during two plenary sessions includes results and updates from these major randomized trials: Continue Reading Heart Failure Society of America Annual Scientific Meeting 2025 takes place September 26-29 in Minneapolis, MN. Sunday, September 28 Plenary Session | 9:00 AM – 10:30 AM Late Breaking Clinical Research 1: Devices and Cardiomyopathies Integra-D Trial Effects of a Novel Cardiac Contractility Modulation-Defibrillator (CCM-D) on NYHA Functional Class in ICD-Indicated Patients: Post-Implant Results from the Integra-D Trial FUTURE-HF Development of an Individualized Congestion Score using a Novel Implantable Inferior Vena Cava Sensor: the FUTURE-HF Trial Portfolio DETECT-HF Development and Training of a Voice-Based Algorithm for Heart Failure Monitoring: Performance results from 599 Patients over 360,000 Patient-Days FOREST-HCM Safety and Efficacy of Aficamten in Patients with Nonobstructive Hypertrophic Cardiomyopathy: a 96-week analysis from FOREST-HCM MAPLE-HCM Divergent Effect of Aficamten Versus Metoprolol on Exercise Performance in Obstructive Hypertrophic Cardiomyopathy: A Prespecified Analysis of MAPLE-HCM ATTRibute-CM Acoramidis Reduces Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Transthyretin Amyloid Cardiomyopathy: Results From ATTRibute-CM HELIOS-B Reduction in Gastrointestinal Events in ATTR-CM Patients Treated with Vutrisiran Compared with Placebo: Analysis from HELIOS-B Monday, September 29 Plenary Session | 9:00 AM – 10:30 AM Late Breaking Clinical Research 2: Novel Therapies VICTOR Trial Vericiguat Efficacy and Safety Across Baseline Background Therapy in Contemporary Ambulatory Patients with HFrEF Enrolled in the VICTOR trial Tolerability and Safety of Vericiguat in Chronic Heart Failure with Reduced Ejection Fraction SEISMiC C Safety and Efficacy of Intravenous Administration of Istaroxime for 48 hours in Patients with SCAI C Cardiogenic Shock due to Acute Heart Failure SUMMIT Trial Effects of Tirzepatide in Obesity-Related HFpEF by Sex: A Prespecified Secondary Analysis from the SUMMIT Trial GARDEN TIMI-74 GDF-15 Neutralization in Patients with Heart Failure: Primary Results of the GARDEN-TIMI 74 Trial Danicamtiv Trial Danicamtiv Restores Ventricular and Atrial Function in Patients with Dilated Cardiomyopathy Caused by Genetic Variants that Depress Sarcomere Function Late Breaking Clinical Research showcases novel results of major randomized trials and rapidly evolving research. Due to the quantity of remarkable trials submitted, HFSA will also feature late breaking research through Rapid Fire Oral Sessions. These Rapid Fire sessions are fast-paced oral presentations spotlighting key data from late breaking clinical research. Sessions take place on Sunday and Monday with Q&A and new topics each day. Sunday September 28 | Rapid Fire 1 | 10:45 AM - 11:45 AM Phase 1 Study of Daratumumab-Hyaluronidase for Reduction of Circulating Antibodies in Patients with High Allosensitization Awaiting Heart Transplantation Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Post-Heart Transplant Patients: A Multi-Center Retrospective Cohort Study Long Term Outcomes after LVAD Weaning for Myocardial Recovery: Results from the VAD Wean Recovery Network First-In-Human Implantation of a Next-Generation Membrane-Based LVAD Long Term Trajectory of Glomerular Filtration Rate Post-LAVD and the Impact on Clinical Outcomes: An analysis of the MOMEMTUM 3 Study Increased LVEF at Six Months Following LVAD Implant is Associated with Improved Long-Term Outcomes - A MOMENTUM-3 Analysis Screening for advanced heart failure in stable outpatients (The SAINTS study) Sunday, September 28 | Rapid Fire 2: | 2:15 PM - 3:15 PM Clinical Outcomes for Heart Failure at High Risk of Hyperkalemia according to Optimization of Agents Targeting the Renin-Angiotensin-Aldosterone System Intravenous Ferric Carboxymaltose in Patients With Ischemic Versus Non-Ischemic Etiology of Heart Failure and Iron Deficiency Residual Risk of Hyperkalemia Among Patients with Heart Failure Treated with SGLT2i and ARNI Instead of ACEI/ARB High-Dose IV Loop Diuretic Therapy and Ototoxicity Risk in Patients with Acute Heart Failure: Insights from the FASTR Trial Expanded Results from a Guideline-Directed Medical Therapy Clinic Optimized Heart Failure Therapy in Patients at Risk of Cardiac Wasting in Patients with Advanced Cancer: Results from the EMPATICC trial Supervised Exercise Training Improves Outcomes in Heart Failure: Evidence from the PACT-HF 2×2 Factorial Trial Sunday, September 28 | Rapid Fire 3 | 4:15 PM - 5:15 PM Cardiac Contractility Modulation Reduces Mortality and Heart Failure Hospitalizations: A Matched Comparison of Patients Receiving and Not Receiving CCM Derived from a Real-World Dataset PROACTIVE-HF: 2-year outcomes, stratified by LVEF Outcomes of Poor Clinical Responders After Transcatheter Aortic Valve Replacement in Older Patients Invasive Hemodynamic Risk Stratification and Transcatheter Edge-to-Edge Tricuspid Repair: One-Year Results from TRILUMINATE Pivotal Trial Relationship between changes in seated pulmonary artery pressure, blood pressure, heart rate, and weight prior to heart failure hospitalization A Randomized Trial of a Remote, Digital Intervention Targeting Heart Failure Medical Therapy Machine-Learning Estimation of Pulmonary Capillary Wedge and Right Atrial Pressures With a Non-invasive Multisensor Device Deep learning assisted prediction for occurrence of pacing-induced cardiomyopathy in the atrio-ventricular block Monday, September 29 | Rapid Fire 4 | 12:00 PM – 1:00 PM Effect of vericiguat, compared with placebo, across baseline risk categories in chronic heart failure with reduced ejection fraction in the VICTOR Trial Effect of Vericiguat on Heart Failure Hospitalisation Events in Ambulatory Patients with Heart Failure and Reduced Ejection Fraction: VICTOR Trial Prespecified Analysis Effect of Vericiguat on Mortality in Ambulatory Patients with Heart Failure and Reduced Ejection Fraction: VICTOR Trial Prespecified Analysis Regional Variation in Outcomes and Response to Vericiguat in Heart Failure with Reduced Ejection Fraction: The VICTOR Trial Effect of the Soluble Guanylate Cyclase Stimulator Vericiguat on Health Status in the Phase 3 VICTOR Trial The Effect of Vericiguat on Mode of Death in Patients with Heart Failure with Reduced Ejection Fraction in the VICTOR Trial Rapidity of benefit of simultaneous initiation of finerenone and empagliflozin in people with chronic kidney disease and type 2 diabetes: the CONFIDENCE trial Dapagliflozin in Patients with Heart Failure: A Meta-Analysis of DAPA-HF, DELIVER, and DAPA ACT HF-TIMI 68 The meeting kicks off in just three weeks. A full schedule at a glance is available online, as well as information on the science and research and networking available at the meeting. Learn more about the meeting and register at hfsa.org/asm2025. About the Heart Failure Society of America The Heart Failure Society of America, Inc. (HFSA) represents the first organized effort by heart failure experts from the Americas to provide a forum for all those interested in heart function, heart failure, and congestive heart failure (CHF) research and patient care. The mission of HFSA is to provide a platform to improve and expand heart failure care through collaboration, education, innovation, research, and advocacy. HFSA members include physicians, scientists, nurses, nurse practitioners, pharmacists, trainees, other healthcare workers and patients. For more information, visit hfsa.org. Media Contact: Laura Poko, 301-798-4493, ext. 226, [email protected] SOURCE Heart Failure Society of America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Phase 1

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

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
Restless Legs Syndrome	Phase 3	United States	American Regent, Inc.	01 Jan 2015
Heart Failure	Phase 3	Germany	Corden Pharma Fribourg SA	21 Nov 2012
Lymphoid neoplasm	Phase 3	Germany	Vifor (International) AG	20 Apr 2010
Lymphoma	Phase 3	Germany	Vifor (International) AG	20 Apr 2010
Multiple Myeloma	Phase 3	Greece	Vifor (International) AG	23 Mar 2010
Anemia	Phase 3	United States	American Regent, Inc.	01 Feb 2005
Metastatic Colorectal Carcinoma	Phase 2	Germany	Vifor SA	30 Sep 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASTRON (OGSG 2401) (ESMO2025)	Not Applicable	Gastrointestinal Neoplasms	50	Ferric carboxymaltose	sqejandovd(bdtahnqwek) = snqpwwiccm ozfqypdnbv (jmixtodgmq ) View more	Positive	17 Oct 2025
NCT01950247 (CTgov)	Phase 4	Anemia, Iron-Deficiency	1,025	Injectafer (Injectafer)	znmimuiyjp(kxubwjcxnl) = lfnhxqfkkh okrltawfnz (wwhfkeaohe, 11.38) View more	-	22 May 2025
				SOC (IV Iron Standard of Care (SOC))	znmimuiyjp(kxubwjcxnl) = dnmeopoldq okrltawfnz (wwhfkeaohe, 11.28) View more
NCT00685815 (RLS, CTgov)	Phase 2	Restless Legs Syndrome	12	Ferric Carboxymaltose (FCM) (Ferric Carboxymaltose (FCM))	wjywitpglj = qdtmeheytj ziemkzlmll (pnhosoyngs, fhshqjopqz - cexcjlydof) View more	-	06 May 2025
				Placebo (Placebo)	wjywitpglj = ukejgqwkcp ziemkzlmll (pnhosoyngs, wywflovqiw - uarsqeawur) View more
NCT00740246 (CTgov)	Phase 3	Anemia, Iron-Deficiency	594	ViT-45 (ViT-45)	nglbodoktm = kpklcbvvol ujuwkywjmn (vwhkvidgsg, rkyytayrvx - vpbimbpfii)	-	18 Apr 2025
				Placebo (Placebo)	nglbodoktm = nesnrjvmvr ujuwkywjmn (vwhkvidgsg, qxffqcqdem - ooldltbajg)
NCT01692418 (PREVENTT, Literature) Manual	Phase 3	Anemia	392	ferric carboxymaltose	zehuyycble(jphuogksei) = qabcrsezov tytesqhqxd (bqtkcpnsfo ) View more	Positive	17 Apr 2025
				Placebo	zehuyycble(jphuogksei) = ubsvikwslg tytesqhqxd (bqtkcpnsfo ) View more
NCT02397057 (Pubmed \| Sleep)	Phase 3	Restless Legs Syndrome	209	ferric carboxymaltose	ongviulvyd(kadwivmdvf) = uokonzvknp dlefedeiea (oqfhzyhske ) View more	Negative	11 Jul 2024
				placebo	ongviulvyd(kadwivmdvf) = sppicykhrn dlefedeiea (oqfhzyhske ) View more
NCT03037931 (HEART-FID, CTgov)	Phase 3	Iron deficiency	3,065	Ferric Carboxymaltose (Ferric Carboxymaltose)	vecubrwkij = avifpgjant kwljjrglms (yogbwiwwxh, tbxhbaapjd - aonzudpgub) View more	-	03 Jul 2024
				Placebo (Placebo)	vecubrwkij = ecfkhfmogm kwljjrglms (yogbwiwwxh, striduulik - oaejilywyl) View more
NCT01690585 (Pubmed \| Age Ageing) Manual	Phase 3	Gastrointestinal Hemorrhage	59	Ferric carboxymaltose	owkelonmge(epqjzkyivj) = fxotdpeuit qmuvrpvswe (sfbvwnfyfs ) View more	Positive	01 May 2024
				Placebo	owkelonmge(epqjzkyivj) = jejhlikbbq qmuvrpvswe (sfbvwnfyfs ) View more
ASH2023	Not Applicable	-	289	Ferric Carboxymaltose (FCM)	yydzbpibqe(dgblomwpwg) = qgsgmbmzlt tvaawbgffa (kmyaeqrtmu )	-	11 Dec 2023
				Ferric Derisomaltose (FDI)	yydzbpibqe(dgblomwpwg) = vomupgmqqo tvaawbgffa (kmyaeqrtmu )
NCT03037931 (HEART-FID, Pubmed \| N Engl J Med)	Phase 3	Iron deficiency \| Heart Failure	3,065	Ferric carboxymaltose	entcwgshck(wqjuihelja) = hiebnbjjvr kupkjzaysa (knzrgykvrm )	-	26 Aug 2023
				Placebo	entcwgshck(wqjuihelja) = grofflfbux kupkjzaysa (knzrgykvrm )

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