NDX-3315 + NDX-3324

NDX-3315 and NDX-3324 are investigational oral radiopharmaceutical agents developed as non-invasive diagnostic imaging tools for the detection, diagnosis, monitoring, and management of eosinophilic esophagitis (EoE). Both agents are designed to bind to Major basic protein 1 (eMBP1), an eosinophil degranulation product central to EoE pathogenesis. The approach aims to provide a safer and more sensitive alternative to current diagnostic standards such as endoscopy with biopsy. These drugs are administered orally as solutions and utilize technetium-based radiolabeling for imaging purposes. Clinical trials have demonstrated proof of concept and established safety in EoE patients. The program has been granted Orphan Drug Designation for EoE[2][3][5][6].