GLEOLAN

Peak

aminolevulinic acid hydrochloride

NDAORALFOR SOLUTIONPriority Review
Approved
Jun 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1

Mechanism of Action

succinyl-CoA and glycine. Exogenous administration of ALA leads to accumulation of the ALA metabolite PpIX in tumor cells. The reason for the accumulation of PpIX in neoplastic brain tissue is not known. During glioma surgery, Gleolan is used with an operating microscope adapted with a blue…

Indications (2)

glioma (suspected World Health Organization Grades IIIIV on preoperative imaging)

Clinical Trials (1)

NCT06160492Phase 3Recruiting

Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)

Started Apr 2025
144 enrolled
5-aminolevulinic AcidFluorescence-guided Resection
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers