The Food and Drug Administration (FDA) has approved Gleolan (aminolevulinic acid HCl; NXDC) for use in patients with gliomas (suspected WHO Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during glioma surgery. This approval marks Gleolan as the first fluorescing agent used with gliomas.

Administration of Gleolan leads to an accumulation of the metabolite PpIX in tumor cells. When used with an operating microscope adapted with a blue emitting light source, the tumor tissue can be visualized as red fluorescence. In contrast, tissues lacking sufficient PpIX concentrations will appear as blue. 

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The approval was supported by three prospective studies that showed aminolevulinic acid-induced fluorescence was highly predictive for visualizing malignant tissue as verified by histopathology of biopsied fluorescent tissue. Five clinical studies (n=527) demonstrated the safety of Gleolan in patients with glioma.

Safety risks associated with Gleolan include phototoxic reactions and hypersensitivity reactions; interpretation errors of false negatives and false positives have also occurred. Common adverse reactions with Gleolan in the week after surgery were pyrexia, hypotension, nausea, and vomiting.

Gleolan will be available as 1500mg strength lyophilized powder for oral solution in 50mL vials. 

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