NDAORALFOR SOLUTIONPriority Review
Approved
Jun 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
GLEOLAN (aminolevulinic acid hydrochloride) by PharmaIN is succinyl-coa and glycine. Approved for glioblastoma. First approved in 2017.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GLEOLAN (aminolevulinic acid hydrochloride) is an oral solution that accumulates as the fluorescent metabolite protoporphyrin IX (PpIX) in glioblastoma cells. During surgery, blue light excitation causes tumor tissue to fluoresce red, enabling real-time visualization and improved resection guidance. It represents a novel intraoperative imaging modality rather than a chemotherapeutic agent.
Peak
GLEOLAN is at peak lifecycle with moderate competitive pressure (30/100), suggesting stable but not rapidly expanding commercial operations and a focused, specialized team.
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 (1)
Clinical Trials (2)
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
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
Started Sep 2019
0Malaria
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.