A Single-center, Evaluator-blinded Clinical Study of Polysaccharide Superparamagnetic Iron Oxide Injection for Magnetic Resonance Venography in Patients With Venous System Diseases

The purpose of this single-center, prospective, evaluator-blinded study is to establish and optimize the imaging protocol for ferumoxytol-enhanced magnetic resonance venography (Fe-MRV) in patients with venous system diseases.
Current gadolinium-based contrast agents used in MRI have limitations, including short circulation half-lives and potential risks for patients with renal impairment. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, offers a longer imaging window and no renal toxicity, making it a promising alternative for vascular imaging.
This study will enroll 50 adult patients with suspected or confirmed venous structural abnormalities or circulation disorders. To determine the minimum effective diagnostic dose, each participant will receive a total dose of 3.0 mg/kg, administered as four equal intravenous aliquots, with MRI performed after each aliquot (cumulative doses: 0.75, 1.50, 2.25, and 3.0 mg/kg). Independent, blinded radiologists will evaluate the image quality at each cumulative dose level to determine the lowest possible dose required to achieve successful clinical diagnosis.

Start Date08 Mar 2026

Sponsor / Collaborator

Nanjing Drum Tower Hospital

NCT07461948

/ RecruitingPhase 3IIT

Advanced MRI for Visualization and Quantification of the Tumor Immune Microenvironment (TIME) in Glioblastoma

This phase III trial is evaluating whether a combination of three advanced magnetic resonance imaging (MRI) techniques, including chemical exchange saturation transfer (CEST) MRI, diffusion-relaxation correlation spectrum imaging (DR-CSI), and ferumoxytol-enhanced magnetic resonance imaging (Fe-MRI) are effective as non-invasive methods for assessing the cells and proteins that surround and interact with tumor cells (the tumor immune microenvironment) in patients with glioblastoma. Researchers understand that some types of brain tumors are harder to treat than others, but the reasons for this are not known in many cases. CEST MRI uses differences in the tissue microenvironment, like protein concentration or intracellular pH, to generate contrast differences. DR-CSI detects microstructural changes in tissue associated with immune cells infiltrating the tumor. Fe-MRI uses ferumoxytol as a contrast agent with MRI. Contrast agents are substances that are injected into the body and taken up by certain tissues, making the tissues easier to see in imaging scans. More advanced imaging techniques like CEST, DR-CSI, and Fe-MRI may offer less invasive methods than surgery or biopsy for helping researchers understand the tumor immune microenvironment in patients with glioblastoma, which may help researchers determine why some tumors are more resistant to treatment.

Start Date27 Oct 2025

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

NCT07066436

/ Not yet recruitingEarly Phase 1IIT

ImmunoMRI for Assessment of Tumor-associated Macrophages: A Prospective Study in Patients With Diffuse Large B-cell Lymphoma Receiving CAR T-cell or Bispecific Antibody Therapy

About 35% of patients with a type of blood cancer called diffuse large B-cell lymphoma don't respond well to standard treatment or their cancer comes back. When this happens, newer treatments like CAR T-cell therapy (using modified immune cells) or bispecific antibodies (special proteins that help the immune system fight cancer) are an option. However, these treatments are only successful in about half the patients. It is currently difficult to predict which patients will respond to these treatments or experience serious side effects. This makes it hard to choose the best treatment plan for a given patient.
In this project, a special type of magnetic resonance imaging (MRI) scan will be used to track immune cells called macrophages that live around tumors. These cells can either help fight cancer or help cancer grow. By understanding how these cells behave, it may be possible to predict treatment success. The MRI technique involves injecting an iron-based substance called ferumoxytol, which can be used as an MRI contrast agent, into patients' veins. This contrast agent gets absorbed by the macrophages, making them visible on MRI scans throughout the entire body - not just one tumor spot. Sixty patients will be scanned before and after treatment (30 getting CAR T-cells, 30 getting bispecific antibodies), and results will be compared with tissue samples.
The goals are to predict which patients will go into complete remission, predict who will survive longer without cancer progression, and identify patients at risk for serious side effects like cytokine release syndrome. If successful, this imaging technique could help to personalize treatment choices, potentially improving outcomes while avoiding unnecessary toxicity in patients who will not benefit from these intensive therapies.

Start Date01 Oct 2025

Sponsor / Collaborator

Medical University of Vienna

100 Clinical Results associated with Ferumoxytol

100 Translational Medicine associated with Ferumoxytol

100 Patents (Medical) associated with Ferumoxytol

14,254

Literatures (Medical) associated with Ferumoxytol

01 Apr 2026·JOURNAL OF CONTROLLED RELEASE

Effect of clinically relevant iron oxide nanoparticles on macrophage polarization, tumor growth and tumor microenvironment modulation

Article

Author: Schulz, Volkmar ; Grimm, Jan ; Lindelauf, Kim ; Rama, Elena ; von Maltzahn, Finn ; Pallares, Roger M ; Lammers, Twan ; Lemainque, Teresa ; Thoröe-Boveleth, Sven ; Dadfar, Seyed Mohammadali ; Barmin, Roman A ; Etrych, Tomas ; Pola, Robert ; Knuechel-Clarke, Ruth ; von Stillfried, Saskia ; Savina, Ekaterina ; Roemhild, Karolin ; Kiessling, Fabian ; Moeckel, Diana ; Li, Yanchen ; Kraus, Thomas ; Boor, Peter

Macrophages are key regulators of the tumor microenvironment (TME) and attractive targets for nanomedicine therapies. Because intracellular iron can promote pro-inflammatory macrophage polarization, superparamagnetic iron oxide nanoparticles (SPION) have been proposed as potential antitumor therapeutics. Nevertheless, their ability to remodel the TME and inhibit tumor growth has remained unclear. Here, we evaluated whether the commercially available SPION formulations Feraheme and Synomag can regulate macrophage polarization, modulate the microenvironment, affect tumor growth, and alter tumor-targeted drug delivery. In vitro, despite being internalized by macrophages highly efficiently, Feraheme and Synomag only elicited modest effects on macrophage polarization markers. In vivo, repeated intravenous administrations of Feraheme in an orthotopic and syngeneic 4 T1 triple-negative breast cancer model resulted in significant increases in intratumoral iron levels. However, they did not affect tumor growth nor statistically significant altered tumor-associated macrophage density and polarization, T-cell subsets, or the composition of the TME. Accordingly, pre-treatment with Feraheme did not alter tumor vascularization or collagen content, nor did it result in a statistically significant improvement in the delivery of a model polymeric nanocarrier. Together, these results support the use of SPION as tracers for macrophage-targeted imaging applications rather than as antitumor therapeutics and TME priming agents.

21 Mar 2026·JOURNAL OF DISPERSION SCIENCE AND TECHNOLOGY

Experimental study on the factors affecting cement bond strength at the second interface of oil-gas well

Author: Liu, Simeng ; Zhou, Ping ; Li, Ming ; Zhang, Zhihao ; Liu, Gang ; Zhao, Zihao ; Guo, Cen

The second interface of cementing refers to the interface formed by the formation and the cement sheath after cementing.The bonding strength of the second cementing interface is mainly generated through the interaction between the cement sheath and the formation.This study employs sandstone and limestone as exptl. materials to investigate the influencing factors on the bonding strength of the second cementing interface by altering the water-cement ratio of the cement slurry system, adding ultrafine materials, and incorporating latex materials.In a progressive exptl. approach, various types of cement slurries are selected, including pure cement slurry systems under different water-cement ratios (L1, L2), cement slurry systems with added nano-silica on the basis of pure cement systems (L3), and cement slurry systems with latex added (L4).The influence factors of the bonding strength of the second cementing interface of cement sheaths are explored through self-developed bonding strength evaluation molds and micro-characterization of the bonding interface.The results indicate that increasing the water-cement ratio or adding nano-silica can promote the generation of calcium silicate hydrate (C-S-H), resulting in higher early bonding strength but lower later strength under sandstone interfaces; the reaction of latex particles themselves to form a three-dimensional network structure can enhance the bonding strength.This research provides significant insights into the bonding laws of the second cementing interface and is of great importance to the cementing construction process.

10 Mar 2026·Blood Advances

Cost-effectiveness of first-line IV vs oral iron for iron-deficiency anemia in women with heavy menstrual bleeding

Article

Author: Wang, Daniel Y. ; Ito, Satoko ; Wang, Daniel ; Hirniak, Sam ; Goshua, George ; Ng, Ding Quan ; Lee, Alfred Ian ; Cuker, Adam ; Sra, Manraj ; Glaeser-Khan, Samira

Abstract:

Iron-deficiency anemia (IDA) affects nearly one-third of women globally, with heavy menstrual bleeding (HMB) being a significant risk factor among those of reproductive age. Despite the substantial burden of HMB-related IDA, patients often face delays in receiving effective treatment. Oral iron is typically used as first-line therapy, despite frequent gastrointestinal side effects and challenges in treatment adherence. This study evaluated the reproductive life span cost-effectiveness of first-line intravenous (IV) vs oral iron therapy for women with HMB and IDA. We developed a Markov model simulating a cohort of women aged 18 to 51 years, comparing first-line treatment with IV iron dextran, IV ferumoxytol, IV iron sucrose, or oral ferrous sulfate. Costs and quality-adjusted life years (QALYs) were estimated from the societal perspective. IV iron dextran was the cost-effective treatment, yielding 19.26 QALYs at a cost of $157 500, compared with 19.10 QALYs at $152 900 for oral ferrous sulfate. The incremental cost-effectiveness ratio for IV iron dextran was $28 600 per QALY. Treatment with IV ferumoxytol and iron sucrose cost $158 300 and $163 500, respectively, and did not provide additional QALY benefit compared with IV iron dextran, which remained the cost-effective treatment across a range of scenarios and sensitivity analyses. Our findings indicate that first-line treatment with IV iron dextran is the cost-effective strategy for managing IDA in women with HMB at commonly accepted willingness-to-pay thresholds. These results support expanding access to IV iron as a first-line option, and highlight the need to reduce treatment delays and insurance-related barriers.

News (Medical) associated with Ferumoxytol

26 Feb 2026

·azurity.com

Azurity Pharmaceuticals Announces Ferabright(TM) (ferumoxytol injection) Now Available in the U.S. for Magnetic Resonance Imaging of the Brain

Ferabright is the first and only iron-based contrast agent for MRI in the brain Woburn, MA — February 26, 2026 — Azurity Pharmaceuticals, Inc. announced today that FerabrightTM (ferumoxytol injection) is now available in the U.S. Ferabright is the first and only iron-based contrast agent indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.1 Ferabright was approved by the U.S. Food and Drug Administration (FDA) in October 2025. “Ferabright is an advanced superparamagnetic iron oxide nanoparticle contrast agent engineered for high relaxivity,” said Ronald Scarboro, CEO of Azurity Pharmaceuticals. “It significantly enhances image contrast and precision in brain tumor delineation compared to non-contrast MRI, offering clinicians a new tool for diagnostic imaging and improved patient care.” In a clinical trial, Ferabright-enhanced MRI significantly improved visualization of primary and secondary brain neoplasms compared with pre-contrast imaging.1 In addition to improved imaging, Ferabright offers an extended imaging window due to its long half-life.1 The relatively large molecular size of Ferabright means it remains intravascular during early time points (blood pool phase) with a plasma elimination half-life of ~21 hours.1,7,9 Brain tumor enhancement is best seen in delayed-phase MRI, when contrast enhancement marks blood-brain barrier breakdown and macrophage uptake.1,2,7,9,10 As an iron-based agent, Ferabright is processed through the body’s natural iron metabolism pathways,3,6,7 potentially reducing concerns related to long-term tissue retention associated with other contrast agents.2,8 And unlike many other agents, Ferabright is a contrast alternative for patients with renal insufficiency and other gadolinium contraindications,2,3,4 enabling access to contrast-enhanced MRI while reducing exposure to heavy metals found in other contrast agents.5 Using an iron‑based contrast agent may also support more environmentally sustainable imaging practices by reducing contrast‑related emissions.11,12,13,14 Azurity Pharmaceuticals acknowledges the invaluable contributions of the Oregon Health & Science University (OHSU) team and the patients who participated in the foundational research, with special recognition to the late Edward Neuwelt, MD, professor and lead investigator in OHSU’s Department of Neurology, whose pioneering work played a critical role in advancing Ferabright toward FDA authorization. “Ferumoxytol expands our MRI toolkit and provides an option for patients who are either contraindicated for or decline gadolinium,” said Csanad Varallyay, MD, PhD, Neuroradiologist based in Portland, Oregon, with longstanding research experience in ferumoxytol-enhanced MRI. Ferabright will be supplied in single-dose vials of 300 mg elemental iron per 10 mL (30 mg/mL) and 510 mg elemental iron per 17 mL (30 mg/mL) for intravenous infusion over at least 15 minutes.1 Ferabright is contraindicated in patients with known hypersensitivity to ferumoxytol, any of Ferabright’s components, or any other intravenous iron products. Reactions have included anaphylaxis.1 IMPORTANT SAFETY INFORMATION FERABRIGHTTM (ferumoxytol injection), for intravenous use FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol. Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following FERABRIGHT infusion including monitoring of blood pressure and pulse during and after FERABRIGHT administration [see Warnings and Precautions (5.1)]. ADDITIONAL IMPORTANT SAFETY INFORMATION Contraindications FERABRIGHT is contraindicated in patients with known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)]. Warnings and Precautions Anaphylaxis and Other Serious Hypersensitivity Reactions: Fatal and serious hypersensitivity reactions, including anaphylaxis presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness, have occurred in patients receiving ferumoxytol products, which contain the same active ingredient as FERABRIGHT. Other adverse reactions potentially associated with hypersensitivity have occurred, including pruritus, rash, urticaria, and wheezing. These reactions have occurred in patients who had no prior exposure to ferumoxytol as well as in patients who previously tolerated ferumoxytol. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with FERABRIGHT. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of ferumoxytol including FERABRIGHT may have more severe outcomes. Carefully consider the potential risks and benefits before administering FERABRIGHT to these patients. FERABRIGHT is contraindicated in patients with known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products [see Contraindications (4)]. Only administer FERABRIGHT as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after FERABRIGHT administration for at least 30 minutes and until clinically stable following completion of infusion. Allow at least 30 minutes after FERABRIGHT infusion for administration of any other medications that may cause serious hypersensitivity reactions or hypotension [see Dosage and Administration (2.1)]. In a clinical study in patients with iron deficiency anemia (IDA) (FERABRIGHT is not approved to treat IDA), regardless of etiology, hypersensitivity reactions were reported in 0.4% (4/997) of patients administered ferumoxytol as an intravenous infusion over at least 15 minutes. These included one patient with severe hypersensitivity reaction and three patients with moderate hypersensitivity reactions. In clinical studies predominantly in patients with IDA and chronic kidney disease (CKD) (FERABRIGHT is not approved to treat IDA or CKD), serious hypersensitivity reactions were reported in 0.2% (4/1,806) of patients administered ferumoxytol as a rapid intravenous injection (not an approved method of administration for FERABRIGHT). Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria, or wheezing) were reported in 3.5% (63/1,806) of these patients. In postmarketing experience with ferumoxytol, fatal and serious anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported [see Adverse Reactions (6.2)]. Hypotension: FERABRIGHT may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following FERABRIGHT administration [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)]. In a clinical study in patients with IDA (FERABRIGHT is not approved to treat IDA), moderate hypotension was reported in 0.2% (2/997) of patients administered ferumoxytol as an intravenous infusion over 15 minutes. In clinical studies in patients with IDA and CKD (FERABRIGHT is not approved to treat IDA or CKD), hypotension was reported in 1.9% (35/1,806) of patients, including three patients with serious hypotensive reactions, who were administered ferumoxytol as a rapid intravenous injection (not an approved method of administration for FERABRIGHT). Hypotension has also been reported in postmarketing experience [see Adverse Reactions (6.2)]. Iron Overload: Use of FERABRIGHT can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Avoid use of FERABRIGHT in patients with iron overload. Magnetic Resonance Imaging Test Interference: Administration of FERABRIGHT may transiently affect the diagnostic ability of MRI. Conduct anticipated MRI studies (other than the intended FERABRIGHT brain imaging) prior to the administration of FERABRIGHT. Alteration of MRI studies may persist for up to 3 months following the FERABRIGHT dose. If MRI is required within 3 months after FERABRIGHT administration, use T1- or proton density-weighted pulse sequences to minimize the FERABRIGHT effects. MRI imaging using T2-weighted pulse sequences should not be performed earlier than 4 weeks after the administration of FERABRIGHT. Maximum alteration of vascular MRI signal is evident for 1 to 2 days following FERABRIGHT administration [see Clinical Pharmacology (12.3)]. FERABRIGHT will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), planar nuclear medicine imaging, or ultrasound. Differences in Magnetic Resonance Imaging Appearance Compared to Gadolinium-Based Contrast: MRI obtained with FERABRIGHT may demonstrate different size, intensity, and pattern of contrast signal in lesions compared to images obtained with gadolinium-based contrast [see Clinical Studies (14)]. Be aware of the potentially limited interpretability of changes in lesion contrast appearance if prior images were not obtained with FERABRIGHT. Adverse Reactions The most common adverse reactions (≥0.65%) are nausea, pruritus, constipation, headache, diarrhea, increased blood pressure, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, red sclera, allergic rhinitis, back pain, vomiting, and increased ALT. (6.1) Additional adverse reactions (≥1%) reported in clinical trials of patients with IDA or patients with IDA and CKD (using dosing regimens and indications not approved for FERABRIGHT), included dizziness, fatigue, peripheral edema, edema, abdominal pain, cough, pyrexia, dyspnea, and muscle spasm. Please note that FERABRIGHT is not approved to treat IDA or CKD and these dosing regimens are not approved for FERABRIGHT. These are not all the possible side effects of FERABRIGHT. Please see Adverse Reactions (6) in the Prescribing Information for a full list. The Important Safety Information does not include all the information needed to use FERABRIGHT safely and effectively. For more information and full Prescribing Information please visit www.Ferabright.com. To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch PP-FRB-5398-US-EN-v1 10/25 References Ferabright [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2025. American College of Radiology. ACR Manual on Contrast Media 2025. Accessed October 19, 2025. https://www.acr.org/Clinical-Resources/Clinical-Tools-and-Reference/Contrast-Manual Toth GB, Varallyay CG, Horvath A, et al. Current and potential imaging applications of ferumoxytol for magnetic resonance imaging. Kidney Int. 2017;92(1):47-66. Adams LC, Jayapal P, Ramasamy SK, et al. Ferumoxytol-enhanced MRI in children and young adults: state of the art. AJR Am J Roentgenol. 2023;220(4):590-603. Finn JP, Nguyen KL, Hu P. Ferumoxytol vs. gadolinium agents for contrast-enhanced MRI: thoughts on evolving indications, risks, and benefits. J Magn Reson Imaging. 2017;46(3):919-923. Daldrup-Link HE, Theruvath AJ, Rashidi A, et al. How to stop using gadolinium chelates for magnetic resonance imaging: clinical-translational experiences with ferumoxytol. Pediatr Radiol. 2022;52(2):354-366. Yagmurlu B, Hamilton BE, Szidonya L, Barajas RF, Iv M. ferumoxytol-enhanced mri in brain tumor imaging. Adv Clin Radiol. 2024;6(1):175-186.American College of Radiology. ACR Manual on Contrast Media 2025. Accessed September 3, 2025. https://www.acr.org/Clinical-Resources/Clinical-Tools-and-Reference/Contrast-Manual FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings. US Food and Drug Administration. Published May 16, 2018. Accessed September 3, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-gadolinium-based-contrast-agents-gbcas-are-retained-body Hamilton BE, Nesbit GM, Dosa E, et al. Comparative analysis of ferumoxytol and gadoteridol enhancement using T1- and T2-weighted MRI in neuroimaging. AJR Am J Roentgenol. 2011;197(4):981-988. McConnell HL, Schwartz DL, Richardson BE, Woltjer RL, Muldoon LL, Neuwelt EA. Ferumoxytol nanoparticle uptake in brain during acute neuroinflammation is cell-specific. Nanomedicine. 2016;12(6):1535-1542. Feraheme [prescribing information]. Waltham, MA: AMAG Pharmaceuticals, Inc; 2022. Dekker HM, Stroomberg GJ, Van der Molen AJ, Prokop M. Review of strategies to reduce the contamination of the water environment by gadolinium-based contrast agents. Insights Imaging. 2024;15(1):62. Brünjes R, Hofmann T. Anthropogenic gadolinium in freshwater and drinking water systems.Water Res. 2020;182:115966. Chazot A, Barrat JA, Gaha M, Jomaah R, Ognard J, Ben Salem D. Brain MRIs make up the bulk of the gadolinium footprint in medical imaging. J Neuroradiol. 2020;47(4):259-265. About Azurity Pharmaceuticals: Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to addressing the critical and often invisible crisis facing overlooked patients by purposefully developing and tailoring innovative pharmaceutical solutions to meet their specific, unmet needs, which are often ignored by the broader industry. By reformulating, adapting, and developing new therapies that meet specialized patient needs, we are delivering treatment alternatives that solve issues impacting patients’ day-to-day lives. With a broad portfolio of more than 50 medicines across 10 therapeutic areas fueling our mission, Azurity has the agility and velocity to provide safe, quality therapies that are reliable and easy to use. For more information, visit www.azurity.com Media Contact media@azurity.com FERABRIGHTTM is distributed by Azurity Pharmaceuticals, Inc. © 2026 Azurity Pharmaceuticals. All rights Reserved. This is intended for viewership in U.S. only. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially. PP-FRB-6730-US-EN-v2 2/26

Drug ApprovalClinical Result

14 Jan 2026

·www.einpresswire.com

ACA Pharma Named Exclusive Distributor for Ferabright™ in Macau, Hong Kong, Singapore, Greater Bay Area & Mainland China

This expanded partnership builds on our work with Feraheme and allows us to offer physicians a complementary, iron-based MRI contrast option for patients with brain tumors.” — Mike Zhou, CEO of ACA Pharma NEW YORK, NY, UNITED STATES, January 14, 2026 / EINPresswire.com / -- ACA Pharma and Azurity Pharmaceuticals are pleased to announce that they have entered into an exclusive distribution partnership under which ACA Pharma will commercialize Ferabright™ (ferumoxytol injection) across Macau, Hong Kong, Singapore, the Guangdong–Hong Kong–Macao Greater Bay Area (GBA) and Mainland China. Ferabright is an iron-based MRI contrast agent indicated in the United States for imaging of the brain in adults with known or suspected malignant neoplasms, helping visualize lesions with a disrupted blood-brain barrier. Ferabright is based on superparamagnetic iron oxide nanoparticles and is processed through the body’s natural iron metabolism pathways, offering an alternative to traditional gadolinium-based agents and the potential to reduce concerns about long-term retention of heavy metals. “We are excited to expand our collaboration with ACA Pharma to bring Ferabright to patients and clinicians across this important region,” said Ronald Scarboro, CEO of Azurity Pharmaceuticals. “With ACA’s established infrastructure and fast-track pathways, we see an opportunity to responsibly introduce this innovative imaging option in markets where the need for advanced brain tumor diagnostics is substantial.” Under the agreement, ACA Pharma will pursue marketing authorization for Ferabright in Hong Kong, Macau, and Singapore, leveraging its Macau Fast-Track platform and Hong Kong/Singapore fast-track pathways in parallel with Feraheme ® submissions. In the Greater Bay Area, ACA intends to integrate Ferabright into its existing network of designated hospitals, with the aim of enabling earlier access for patients while longer-term national registration in Mainland China is prepared. “This expanded partnership builds on our work with Feraheme and allows us to offer physicians a complementary, iron-based MRI contrast option for patients with brain tumors,” said Mike Zhou, CEO of ACA Pharma. “Working closely with Azurity, we plan to combine fast-track access routes with real-world evidence generation, so that appropriate patients in our region can benefit from Ferabright as global experience grows.” ACA Pharma and Azurity plan to collaborate with leading neuroradiology and neuro-oncology experts across the Greater Bay Area and other key centers in China and Southeast Asia to support responsible adoption of Ferabright. Educational activities are expected to focus on patient selection, imaging protocols, and the role of iron-based contrast agents as part of the broader MRI toolkit, including for patients who may not be candidates for gadolinium-based products. About ACA Pharma Founded in 1997, ACA Pharma is a U.S.-headquartered company specializing in fast-track registrations, early access programs, and end-to-end commercialization for innovative medicines and medical devices across Greater China and Southeast Asia. The company’s Macau Fast-Track and Hong Kong Fast-Track platforms can enable market entry for priority products in a matter of months, with these hubs serving as launchpads into the Greater Bay Area and other national pilot zones. ACA Pharma’s integrated capabilities span regulatory strategy, market access, medical affairs, pharmacovigilance, supply chain, and commercial execution. Learn more at www.acapharma.net About Azurity Pharmaceuticals Azurity Pharmaceuticals is a privately held company committed to delivering innovative, high-quality medicines for overlooked patients. Azurity’s global footprint is over 50 countries, with a diversified portfolio of 50+ medicines spanning 10 dosage forms and 10 key therapeutic areas. Our medicines have benefited millions of people. For more information, visit www.azurity.com . About Ferabright™ (ferumoxytol injection) Ferabright™ (ferumoxytol injection) is an iron-based contrast agent indicated in the United States for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms of the brain to visualize lesions with a disrupted blood-brain barrier. Ferabright uses superparamagnetic iron oxide nanoparticles designed to enhance image contrast and delineation of brain tumors compared with non-contrast MRI. Because Ferabright is processed through normal iron metabolism pathways, it offers a non-gadolinium alternative and can be used in patients with renal insufficiency in accordance with its approved label. For full U.S. prescribing information, including important safety information and Boxed Warning, please visit Ferabright.com. Media Contacts ACA Pharma: team@acapharma.net Azurity Pharmaceuticals: media@azurity.com Ferabright™ and Feraheme ® are registered trademarks of Covis Pharma GmbH, a wholly-owned subsidiary of Azurity Pharmaceuticals. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially. Subject to applicable law, rules, or regulations, the parties do not have any and undertake no obligations to update or otherwise revise the forward-looking statements in this press release, whether as a result of new information, future events or developments, or otherwise. Judy Acidre ACA Pharma +1 718-790-5069 info@acapharma.net Visit us on social media: LinkedIn YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

License out/in

13 Jan 2026

·www.drugs.com

IV Iron Dextran Cost-Effective for Managing Iron-Deficiency Anemia

TUESDAY, Jan. 13, 2026 -- Intravenous (IV) iron dextran is the most cost-effective strategy for managing iron-deficiency anemia (IDA) in women with heavy menstrual bleeding (HMB), according to a study published online Jan. 8 in Blood Advances . Daniel Wang, from the Yale School of Medicine in New Haven, Connecticut, and colleagues examined the reproductive lifetime cost-effectiveness of first-line IV versus oral iron therapy for women with HMB and IDA. A Markov model was developed to simulate a cohort of women aged 18 to 51 years comparing first-line treatment with IV iron dextran, IV ferumoxytol , IV iron sucrose, or oral ferrous sulfate . The researchers found that IV iron dextran was the most cost-effective treatment, yielding 19.26 quality-adjusted life years (QALYs) at a cost of $157,500 versus 19.10 QALYs costing $152,900 for oral ferrous sulfate. For IV iron dextran, the incremental cost-effectiveness ratio was $28,600 per QALY. The costs of treatment with IV ferumoxytol and iron sucrose were $158,300 and $163,500, respectively, with no additional QALY benefit versus IV iron dextran. Across a range of sensitivity analyses and scenarios, IV iron dextran remained the most cost-effective treatment. "Oral iron is usually given as first-line treatment because on the surface, it appears less expensive and more convenient," Wang said in a statement. "However, we found that the preferred first-line treatment for these patients is IV iron as it delivers the highest value for cost and substantially improves quality of life." One author disclosed ties to the pharmaceutical and medical technology industries. Abstract/Full Text (subscription or payment may be required)

Clinical Result

100 Deals associated with Ferumoxytol

External Link

KEGG	Wiki	ATC	Drug Bank
D04177	Ferumoxytol	B03	DB06215

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Brain Cancer	United States	Covis Pharma Holdings BV	16 Oct 2025
Brain Cancer	United States	Covis Pharma GmbH	16 Oct 2025
Chronic Kidney Diseases	European Union	Takeda Pharma A/S	15 Jun 2012
Chronic Kidney Diseases	Iceland	Takeda Pharma A/S	15 Jun 2012
Chronic Kidney Diseases	Liechtenstein	Takeda Pharma A/S	15 Jun 2012
Chronic Kidney Diseases	Norway	Takeda Pharma A/S	15 Jun 2012
Anemia, Iron-Deficiency	Canada	AMAG Pharmaceuticals, Inc.	01 May 2012
Anemia in chronic kidney disease	United States	Covis Pharma Holdings BV	30 Jun 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Iron deficiency anemia of pregnancy	Phase 3	United States	AMAG Pharmaceuticals, Inc.	17 Dec 2018
Anemia	Phase 3	United States	AMAG Pharmaceuticals, Inc.	01 May 2004
Pediatric Cerebellar Astrocytoma	Phase 2	-	AMAG Pharmaceuticals, Inc.	20 Oct 2017
Restless Legs Syndrome	Phase 2	United States	AMAG Pharmaceuticals, Inc.	01 Aug 2014
Cardiovascular Diseases	Phase 2	United States	AMAG Pharmaceuticals, Inc.	09 Apr 2013
Peripheral Arterial Disease	Phase 2	United States	AMAG Pharmaceuticals, Inc.	01 Sep 2008
Nephrosis	Phase 1	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	09 Jun 2023
Esophageal Carcinoma	Phase 1	-	AMAG Pharmaceuticals, Inc.	01 May 2016
Recurrent Malignant Glioma	Phase 1	United States	AMAG Pharmaceuticals, Inc.	01 Oct 2008
Vascular Diseases	IND Approval	China	Suzhou Xinying Biomedical Technology Co., Ltd	18 Jul 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03347617 (CTIM-33, CTgov)	Phase 2	Glioblastoma Multiforme	52	Laboratory Biomarker Analysis+Ferumoxytol+Pembrolizumab	yftwybufhg = liyyzkyhkp shdnzehhjf (fqypexqycl, ggjekclouk - hqletqsddc) View more	-	09 Sep 2025
NCT04253626 (CTgov)	Phase 3	Anemia, Iron-Deficiency	83	Ferrous Sulfate (Oral Iron)	kkpfnajuqs(mpjgbkwexo) = wcbpnrypco dbrfyushit (sxiqokncin, ogfzxxrdnc - luawkxxgyz) View more	-	26 Aug 2025
				Ferumoxytol Injection [Feraheme] (Intravenous Iron)	kkpfnajuqs(mpjgbkwexo) = qpuplgosrp dbrfyushit (sxiqokncin, qysyvijyts - reincoqhzm) View more
NCT02893293 (Osteonecro, CTgov)	Phase 4	Osteonecrosis	14	Magentic Resonance Imaging+Ferumoxytol (Ferumoxytol-enhanced MRI)	rykcwhvdkc(dceoyoudpv) = rmucagpako jrsenubgxp (ndqxdgkojv, 12.43) View more	-	26 Nov 2024
				Magentic Resonance Imaging (Non-ferumoxytol Enhanced MRI)	rykcwhvdkc(dceoyoudpv) = ozijfafije jrsenubgxp (ndqxdgkojv, 10.93) View more
NCT06110494 (CTgov)	Phase 4	Periapical Periodontitis \| Dental Pulp Diseases	44	supplementary irrigation+Iron oxide nanoparticles treatment Ferumoxytol/H2O2 (Iron Oxide Nanoparticles Treatment Ferumoxytol/H2O2)	jifxyucexx(myklbugkgn) = guqhsigmvu hcjsofcqot (ktepfchnxz, dbkpvtcrti - qsaegadzlg) View more	-	28 Aug 2024
				NaOCl+supplementary irrigation (Sodium Hypochlorite (NaOCl))	jifxyucexx(myklbugkgn) = jgzvoqjtah hcjsofcqot (ktepfchnxz, ghfjuqzzib - ifzkmsvfpm) View more
NCT00659126 (CTgov)	Phase 2	Brain metastases	40	Gadolinium+Ferumoxytol (Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 3 Tesla in Subjects With Brain Tumors)	plfxazlmgt(qoxxnpjsyj) = fcgnparjdv ttydpbceph (phtlwcyevm, .923) View more	-	07 Sep 2023
				Gadolinium+Ferumoxytol (Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 7 Tesla in Subjects With Brain Tumors)	plfxazlmgt(qoxxnpjsyj) = jbqdffmilj ttydpbceph (phtlwcyevm, .519) View more
NCT02499354 (IVOR-IDA, CTgov)	Phase 2	Restless Legs Syndrome \| Anemia, Iron-Deficiency	100	Ferrous sulfate (Oral Iron)	cypacffvzr(yqyyuciysc) = qnoalswdxk qrmczyjqdr (hbatclqvua, 9.75) View more	-	15 Aug 2023
				Ferumoxytol intravenous (IV Iron)	cypacffvzr(yqyyuciysc) = phlzcfftlg qrmczyjqdr (hbatclqvua, 8.33) View more
NCT04080908 (AMAGFeraheme, CTgov)	Phase 4	Anemia \| Iron deficiency	1	Ferumoxytol injection	wajdouuiks(fwxchmwtkq) = erbrjpbduk ptldripahy (sxpgopidkx, 0) View more	-	18 Jul 2023
NCT03657433 (Pubmed \| Am J Obstet Gynecol MFM)	Not Applicable	Anemia	124	Intravenous ferumoxytol	zocbixtwup(tznjgmdhln) = xyeahcfezc tydfnrxxyf (daooalqdzx, 1.57 - 2.14) View more	Positive	20 Jun 2023
				Oral ferrous sulfate	zocbixtwup(tznjgmdhln) = wljvjbjvwh tydfnrxxyf (daooalqdzx, 0.42 - 1.17) View more
NCT03657433 (Pubmed \| Am J Obstet Gynecol MFM)	Not Applicable	Anemia, Iron-Deficiency	124	Intravenous ferumoxytol	wftjmxwocl(lptgndprgy) = qcwwuxviej emagovanyv (qlnzbdtvsc ) View more	-	20 Jun 2023
				Oral ferrous sulfate	wftjmxwocl(lptgndprgy) = mdctjvoxfz emagovanyv (qlnzbdtvsc ) View more
NCT04839185 (CTgov)	Early Phase 1	Fetal Growth Retardation \| Visible Lesion	3	MRI scan+Ferumoxytol infusion	yhaojmejup = qwwnpebeao djlghtygoo (hpxfelaxfc, nxnjftejtu - dxkqadxvos) View more	-	12 May 2023

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