An Open Label, Single-Center, Safety and Pharmacokinetic Study of Lumitrace® Injection (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR System Using the TGFR Reusable Sensor With TGFR Disposable Ring for the Evaluation of Kidney Function in Patients With Heart Failure

The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure.
The main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement.
Participants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.

Start Date01 Feb 2026

Sponsor / Collaborator

MediBeacon, Inc.

CTIS2025-521795-58-00

/ Not yet recruitingPhase 4

Contrast Strategy In Fenestrated EndoVascular Aneurysm Repair Randomized Control Trial

Start Date01 Jan 2026

Sponsor / Collaborator

Region Skåne Holding AB

NCT07246265

/ Not yet recruitingNot ApplicableIIT

Morphine Clearance and Glomerular Filtration in Sickle Cell Patients in Crisis in Intensive Care

Background: Sickle cell disease is a genetic disorder of haemoglobin (which carries oxygen in red blood cells). The shape of sickle cell-patients' red blood cells is abnormal. Thus, red blood cells can be blocked in small vessels, responsible for painful crises due to a lack of downstream circulation. These crisis (acute vaso-occlusive crisis) require strong treatment based on morphine, and often require intensive care.However, treatment is often insufficiently effective. Patient can also experiment acute chest syndrome, a complication of vaso-occlusive crisis, which can be responsible for respiratory failure. In addition, patients with sickle cell disease frequently have kidney damage called sickle cell nephropathy, which in the early stages of the disease is responsible for renal hyperfiltration, meaning that the kidneys filter the blood more than necessary, with faster elimination of drugs. For example, it is known that higher doses of antibiotics must be used in these patients than in the general population for the same effectiveness. The hypothesis of the study is that morphine, a drug eliminated by kidneys, is underdosed in patients with sickle cell disease, which is responsible for the difficulties in achieving sufficient analgesia.
Objective: To determine the glomerular filtration rate threshold for which it is necessary to prescribe higher doses of morphine in sickle cell patients with vaso-occlusive crisis.
Methods: inclusion of 100 patients admitted to intensive care for an acute vaso-occlusive crisis or acute chest syndrome and receiving morphine. Within 24 hours of study inclusion, four morphine dosages will be performed, in parallel with a precise determination of the glomerular filtration rate by measuring the elimination rate of a tracer, 100% eliminated by the kidneys and injected at the start of the study. This tracer is iohexol, a contrast agent commonly used in radiology. Morphine underdosage will be interpretated regarding glomerular filtration rate. The effectiveness of analgesia and the amount of analgesics required will be also be analyzed.
Outlook: At the end of this study, the investigators will be able to offer adapted doses of morphine for sickle cell patients in crisis, adapted to glomerular filtration rate, in the aim of personalizing analgesia.

Start Date01 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Iohexol

100 Translational Medicine associated with Iohexol

100 Patents (Medical) associated with Iohexol

2,985

Literatures (Medical) associated with Iohexol

01 Feb 2026·TISSUE & CELL

Ameliorative effects of hesperidin against iohexol-induced acute kidney injury: Modulating the levels of NF-κB/TNF-α/IL-1β, JAK2/STAT3, and Wnt3a/Dvl-2 signaling pathways

Article

Author: Şimşek, Hasan ; Caglayan, Cuneyt ; Akaras, Nurhan ; Kandemir, Fatih Mehmet ; Kandemir, Özge ; Mutlu, Hüseyin ; Mutlu, Fatih

Iohexol is a non-ionic contrast agent widely used in diagnostic imaging and angiographic procedures; however, its administration carries the risk of contrast-induced nephropathy. This study was conducted to investigate the ameliorative effects of hesperidin use against iohexol-induced acute kidney injury (AKI) in rats. Male wistar albino rats were randomly assigned into five groups: i) control, ii) hesperidin (100 mg/kg/day orally), iii) iohexol (3 g/kg, i.p), iv) iohexol (3 g/kg) and hesperidin (100 mg/kg) and v) iohexol (3 g/kg) and hesperidin (200 mg/kg). The induction of AKI was performed by dehydration and the administration of contrast media (iohexol) and inhibitors of prostaglandin (indomethacin) and nitric oxide synthesis (L-NAME: N-nitro L-arginine methyl ester). Hesperidin was administered for two weeks before the induction of AKI. Results showed that iohexol induced significant histopathological kidney damage and increased serum urea and creatinine levels. Molecular analyses revealed that iohexol suppressed AQP1 and AQP2 expression, while upregulating KIM-1 and inflammatory markers such as MAPK14, JAK2/STAT3, TRAF6/ACT1/IL-17A, and NFκB/TNF-α/IL-1β at the gene expression level. Furthermore, iohexol decreased the measured activity of antioxidant enzymes (SOD, CAT and GPx) and the GSH content, and significantly increased MDA levels. Additionally, iohexol promoted apoptosis mediated by Caspase-3, Bax, and Bcl-2, and suppressed gene expression of Wnt3a/Dvl-2 and Cyclin D1, which are involved in cell cycle regulation and development. This is the first study to link hesperidin with modulation of Wnt3a/Dvl-2 signaling in iohexol-induced AKI. Hesperidin treatment significantly modulated these parameters, demonstrating a nephroprotective effect. Thus, it was supported that hesperidin could be a potential nephroprotective agent.

01 Feb 2026·CHEMISTRY & BIODIVERSITY

Iohexol Triggers Cytotoxicity but Not DNA Damage in Human Endothelial Cells: Potential Involvement of XIAP Binding

Article

Author: Kenger, İbrahim Halil ; Bilgin, Batuhan

ABSTRACT:

This study used a combination of in vitro and in silico analyses to characterize the cytotoxic, genotoxic, and molecular interaction profiles of iohexol in human umbilical vein endothelial cells (HUVECs). Cytotoxicity was assessed using the MTS assay at concentrations of 1.826, 18.26, 91.3, and 182.6, and DNA damage was evaluated with the comet assay (alkaline single‐cell gel electrophoresis) at concentrations of 9.8, 19.6, 39.2, and 78.4 mM. In addition, molecular docking was performed to investigate the interaction between iohexol and the X‐linked inhibitor of apoptosis protein (XIAP). Iohexol induced concentration‐dependent cytotoxic effects in HUVECs; however, no statistically significant DNA strand breaks were detected. Molecular docking revealed a binding energy of −6.53 kcal/mol, indicating a notable interaction between iohexol and XIAP. These findings suggest that iohexol exerts cytotoxic effects at high concentrations but lacks genotoxic potential under the tested conditions. The observed interaction with XIAP may provide insight into the mechanisms by which contrast agents induce apoptosis.

01 Feb 2026·Radiology case reports

Contrast‑induced encephalopathy: An allergological point of view

Article

Author: Garbán, Patricia Andrade ; Malumbres, Marta Goyanes ; Labrador, María González ; Tejedor-Alonso, Miguel Ángel ; Corbella, Carolina Calvo ; Mayo-Canalejo, Diego ; Izquierdo-Fernández, Raquel ; Pérez-Codesido, Sabela

The intravascular administration of iodinated contrast agents (IC) can be associated with rare neurological complications such as contrast-induced encephalopathy (CIE). CIE has been primarily reported following cardiac and cerebrovascular angiographic procedures and after endovascular treatment of aneurysms. A 61-year-old woman with a history of breast cancer and recurrent respiratory infections presented with respiratory symptoms and persistent fever despite outpatient antibiotic therapy. A thoracic AngioCT with Iomeprol ruled out pulmonary thromboembolism, suggesting an infection. A few hours later, the patient developed acute confusion, behavioral changes, incoherent speech, and an erythematous rash on the trunk and proximal limbs. She was admitted to exclude ischemic, hemorrhagic, and infectious causes. A non-contrast cranial CT and lumbar puncture showed no significant findings. Other tests, including blood work, venous blood gas, and SARS-CoV-2 PCR, were normal. The patient improved spontaneously within 48 hours. A subsequent cerebral MRI with gadolinium showed no abnormalities. Given the likely association with contrast administration, the patient was referred to our Allergy Clinic. An allergological evaluation was performed, including patch and skin prick tests with Iohexol, Iodixanol, Iobitridol, Iomeprol, and Ioversol. All tests returned negative results at the 48- and 96-hour readings. The patient was discharged with a recommendation to avoid IC, except in very exceptional circumstances. CIE is a very rare, acute, and generally transient complication following the administration of IC. We highlight the importance of being aware of this adverse effect of IC, as it can lead to consultations with allergists.

News (Medical) associated with Iohexol

11 Feb 2026

·www.biospace.com

Transdermal GFR Article Recognized as One of Five 2025 Editors’ Choice Articles by Journal of the American Society of Nephrology (JASN)

MediBeacon ® Transdermal GFR System is a first-in-kind product for point of care kidney function assessment Centers of Excellence commercialization in select academic medical centers began in January 2026 ST. LOUIS, Feb. 10, 2026 (GLOBE NEWSWIRE) -- MediBeacon Inc. , a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection, today announced that the peer-reviewed transdermal GFR measurement article published in the Journal of the American Society of Nephrology (JASN) has been recognized as one of five 2025 Editor’s Choice articles. 1 The JASN editorial team selects five top articles each year which exemplify the highest potential to inform future research, change clinical practice, and/or guide public policy, particularly in the United States. The article was featured on the cover of the Journal of the American Society of Nephrology (JASN) in August 2025. 2 The TGFR ™ System is comprised of Lumitrace ® (relmapirazin) injection, the TGFR ™ Monitor and TGFR ™ Reusable Sensor and enables the assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The result is a transdermal assessment of Glomerular Filtration Rate or kidney function (tGFR). “There is an acute need for improved GFR assessment at the point of care. Assessing the impact of physiologic changes or diseases on GFR in is of high potential clinical value. The limitations of estimated GFR (eGFR) are well known and existing measured GFR (mGFR) methodologies are not well suited to general clinical practice,” said Dr. Steve Miller, Chief Medical Officer for MediBeacon. “Many of the top institutions view transdermal GFR (tGFR) as a potential clinical practice game changer targeting a new standard of care for patients in numerous cases where the understanding of kidney function is fundamental.” “We are excited about this recognition by American Society of Nephrology,” said Steven Hanley, CEO and Co-Founder of MediBeacon. “Our deployment of the TGFR System across key centers of excellence, initially targets use in heart failure monitoring, transplant evaluation and oncology drug dosing. Our collaboration with the top hospitals globally demonstrates this focus to strategically drive early commercial adoption of our technology where it can rapidly be demonstrated to have high clinical value.” Media and Investor Contact Ji-Yon Yi investors@medibeacon.com About MediBeacon Inc . MediBeacon is a medical technology company specializing in the advancement of fluorescent tracer agents and their transdermal detection. MediBeacon’s use of proprietary fluorescent tracer agents coupled with transdermal detection technology focuses on providing vital and actionable measurement of organ function. MediBeacon owns over 55 granted U.S. patents and over 250 granted patents worldwide that provide extensive coverage of the MediBeacon ® TGFR™ System, including Lumitrace ® injection, the sensor and algorithms, as well as other strategic uses of its proprietary pyrazine platform and sensor technology. The TGFR System is approved for human use. Potential technology applications in gastroenterology, ophthalmology and surgery are in various stages of clinical development. MediBeacon is based in St. Louis, Missouri, with additional operations in Mannheim, Germany. For more information, please visit: . About Lumitrace ® (relmapirazin) injection Relmapirazin is a non-radioactive, non-iodinated pyrazine-based compound, which has been engineered to be inert, highly fluorescent, and have the clearance properties of a GFR tracer agent in the body. The unique photophysical characteristics of Lumitrace have been designed to enable the collection of fluorescence data via a photodetector sensor placed on the skin. Data collected by the sensor measures the change in the intensity of Lumitrace fluorescence over time and is converted into a transdermal GFR (tGFR) by proprietary algorithms. In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values. See the peer reviewed article published in the October 2024 issue of Kidney International by Dorshow et al. 3 About MediBeacon ® TGFR™ System The MediBeacon ® TGFR ™ System is comprised of the TGFR ™ Reusable Sensor, TGFR ™ Monitor, TGFR ™ Disposable Ring, and Lumitrace ® (relmapirazin) injection, which together allow assessment of kidney function by measuring the clearance rate of the fluorescent agent as it leaves the body. The system records Lumitrace fluorescence intensity transdermally as a function of time via a sensor placed on the skin. The TGFR Reusable Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the point of care. FOR IMPORTANT SAFETY INFORMATION FOR THE TGFR SYSTEM (U.S. FDA) see ifu.medibeacon.com . 1 2 Glomerular Filtrate Rate Measurement Utilizing Transdermal Detection Methodology; Dorshow, Richard B., Debreczeny, Martin P.; Goldstein, Stuart L.; Journal of the American Society of Nephrology, 36(8):p 1592-1602, August 2025. DOI: 10.1681/ASN 0000000639 3 Clinical validation of the novel fluorescent glomerular filtration rate tracer agent relmapirazin (MB-102), Kidney International, Volume 106, Issue 4, P679-687, October 2024, DOI: 10.1016/j.kint.2024.06.012

Clinical ResultPhase 2

01 Dec 2025

·www.businesswire.com

Bayer’s MEDRAD ® Centargo Multi-Patient CT Injection System Now With A Wider Range of Compatible CT Contrast Agents and Presentations

Centargo compatible with Ultravist ® (iopromide), Isovue ® (iopamidol), Optiray ® (ioversol), Omnipaque™ (iohexol) and now, Visipaque™ (iodixanol) Follows recent FDA clearance to expand the use of compatible contrast agent presentations, adding single-dose vials in addition to Imaging Bulk Package presentations Radiology suites now have the ability to further manage contrast consumption and waste, while providing greater flexibility for those transitioning to bulk contrast use WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that its MEDRAD® Centargo multi-patient CT injector has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the use of compatible contrast agent presentations to include single-dose vials in addition to the previously cleared Imaging Bulk Package (IBP) presentations for Ultravist® (iopromide), Isovue® (iopamidol), Optiray® (ioversol) and Omnipaque™ (iohexol). Additionally, Bayer announced the addition of Visipaque™ (iodixanol) in single-dose vials as Centargo’s fifth compatible contrast agent. This expansion now offers customers in high-throughput imaging suites a wider range of compatible contrast agents and presentations from Centargo. “We know our customers operating high-volume suites, who serve dozens of patients daily, require flexible and cost-effective solutions to meet their unique needs,” said Jill Carbone, Vice President and Head of Radiology North America Product & Pipeline, Bayer. “The expanded presentations will further support healthcare providers by helping to improve efficiency in end-of-day procedures, providing greater flexibility for those still transitioning to bulk contrast use, and supporting their broad imaging needs with an option to use any of the five leading contrast agents.” The MEDRAD® Centargo CT Injection System helps reduce process and administrative burdens for healthcare providers, enabling them to focus more on patient care, particularly in high throughput settings. By integrating with Bayer’s portfolio of imaging and Cortenic™ Connectivity workflow solutions, healthcare providers can optimize contrast-usage and enable connectivity to the scanner, hospital radiology information systems and Bayer services. For more information about MEDRAD® Centargo, powered by Cortenic™ Connectivity, visit: www.Centargo.com. Full Prescribing Information for Ultravist is available at this link: https://labeling.bayerhealthcare.com/html/products/pi/Ultravist_PI.pdf About Radiology at Bayer Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions and a medical imaging platform with digital and artificial intelligence (AI) powered applications. In 2024, Bayer’s radiology products generated €2.1 billion in sales. Bayer continues to advance research and innovation in medical imaging, including the integration of AI. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on X: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

01 Dec 2025

·www.bayer.com

Bayer’s MEDRAD® Centargo Multi-Patient CT Injection System Now With A Wider Range of Compatible CT Contrast Agents and Presentations

WHIPPANY, N.J., December 1, 2025 – Bayer today announced that its MEDRAD® Centargo multi-patient CT injector has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the use of compatible contrast agent presentations to include single-dose vials in addition to the previously cleared Imaging Bulk Package (IBP) presentations for Ultravist® (iopromide), Isovue® (iopamidol), Optiray® (ioversol) and Omnipaque™ (iohexol). Additionally, Bayer announced the addition of Visipaque™ (iodixanol) in single-dose vials as Centargo’s fifth compatible contrast agent. This expansion now offers customers in high-throughput imaging suites a wider range of compatible contrast agents and presentations from Centargo. The MEDRAD® Centargo CT Injection System helps reduce process and administrative burdens for healthcare providers, enabling them to focus more on patient care, particularly in high throughput settings. By integrating with Bayer’s portfolio of imaging and Cortenic™ Connectivity workflow solutions, healthcare providers can optimize contrast-usage and enable connectivity to the scanner, hospital radiology information systems and Bayer services. For more information about MEDRAD® Centargo, powered by Cortenic™ Connectivity, visit: www.Centargo.com. Full Prescribing Information for Ultravist is available at this link: https://labeling.bayerhealthcare.com/html/products/pi/Ultravist_PI.pdf About Radiology at BayerBuilding on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions and a medical imaging platform with digital and artificial intelligence (AI) powered applications. In 2024, Bayer’s radiology products generated €2.1 billion in sales. Bayer continues to advance research and innovation in medical imaging, including the integration of AI. About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. Forward-Looking StatementsThis release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Media Contact: Elaine ColónBayer Media Relationselaine.colon@bayer.com +1-732-236-1587

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100 Deals associated with Iohexol

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KEGG	Wiki	ATC	Drug Bank
D01817	Iohexol	V08AB02	DB01362

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Indication	Country/Location	Organization	Date
Neoplasms	United States	GE Healthcare, Inc.	24 Oct 1995
Contrast agents	United States	GE Healthcare, Inc.	26 Dec 1985

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Kidney Injury	Phase 2	-	Ligand Pharmaceuticals, Inc.	01 Mar 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03618420 (CASPER, CTgov)	Phase 1/2	Diabetes Mellitus, Type 1 \| Diabetic Nephropathies	50	Iohexol Inj 300 mg/mL+Aminohippurate Sodium Inj 20%	ojwyzhwour(fmufxnmumw) = pssvmoliit rsihwcbjyu (htyaemncyu, 5.0) View more	-	31 Aug 2021
NCT02246998 (CTgov)	Phase 4	HIV Infections	72	STB+iohexol (STB + Iohexol)	ppcfnrtoeq(gghqkxewes) = qspuamduld opqqbknqwx (tbugavhuzj, 23.28) View more	-	03 Jan 2018
NCT02246998 (CTgov)	Phase 4	HIV Infections	72	ATV+iohexol+TVD+RTV (TVD + ATV/r + Iohexol)	ppcfnrtoeq(gghqkxewes) = kkqvyopnxm opqqbknqwx (tbugavhuzj, 27.16) View more	-	03 Jan 2018

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