Neufeld, Austria, January xxth, 2026 – Sanochemia Pharmazeutika GmbH today announced the submission of a Marketing Authorization Application (MAA) via decentralized procedure (DCP) for Ferumoxtran, an investigational ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle–based MRI imaging agent intended for the detection and characterisation of lymph node metastases in prostate cancer patients.
The MAA seeks approval for Ferumoxtran for the characterisation and localisation of lymph nodes visualised with magnetic resonance imaging (MRI) in the evaluation of primary tumour spread in adults. Ferumoxtran employs a distinct MRI imaging mechanism that extends beyond conventional extracellular contrast distribution.
“The submission represents an important step in the development of MR Imaging approaches,” said Thomas Erkinger, Managing Director of Sanochemia. “It is a defining milestone for Sanochemia and aligns with our long-term ambition to further evolve diagnostic solutions.”
“Ferumoxtran-enhanced MRI represents a major achievement in imaging of lymph nodes in prostate cancer patients,” said Dr. Patrik Zamecnik, Medical Advisor to Sanochemia. “It provides high-resolution imaging without the need for ionizing radiation, detecting even small intra-nodal metastatic deposits. This technique could improve diagnostic confidence and patient management in prostate cancer patients.”
The submission is supported by data from the pivotal Phase III PROSTAPROGRESS study (EudraCT 2018-004310-18), conducted by SPL Medical B.V. (Nijmegen, The Netherlands), which evaluated the efficacy and safety of Ferumoxtran in prostate cancer patients. Sanochemia has secured exclusive global commercialization rights from SPL medical together with its shareholder b.e.imaging (Germany, Switzerland, Austria).
About the Phase III
The multicentric prospective PROSTAPROGRESS Study investigated the use of Ferumoxtran as MRI contrast for lymphatic metastases in prostate cancer. The trial included prostate cancer patients with a medium to high risk for lymph node metastases and without prior treatment. The study has confirmed the primary as well as further secondary endpoints. Post-hoc analysis revealed elevated sensitivity and specificity data for metastatic lymph node lesions, suggesting potential advantages over current technologies. (Pienta et al. J Urol. 2021 July;206(1): 52–61).
About Ferumoxtran
Ferumoxtran consists of ultrasmall superparamagnetic particles of iron oxide (USPIO). The dextran-coated iron oxide nanoparticles accumulate in macrophages, leading to a significant decrease in MRI signal. The dosage applied, 2.6 mg Fe/kg body weight, is significantly lower than the usual dosage for the widely used i. v. iron substitution products. Ferumoxtran may be used in MRI as a blood pool agent for angiography and for functional diagnostics in conjunction with the detection of even very small lymph node metastases. Ferumoxtran is already administered in a named-patient-use program in Nijmegen, Netherlands.
Regulatory disclaimer Ferumoxtran is an investigational medicinal product and is currently under review (DCP with Sweden as Reference Member State). Marketing authorization has not yet been granted.