GLEOLAN (aminolevulinic acid hydrochloride)
Gleolan is an optical imaging agent used for patients with high-grade gliomas, specifically those suspected to be WHO Grades III or IV. It helps surgeons visualize malignant tissue during brain surgery by making the tumor cells stand out from healthy tissue. This tool is used as an adjunct to assist in the identification of cancerous areas while the patient is in the operating room.
How GLEOLAN Works
This drug works by causing a specific metabolite called PpIX to accumulate within tumor cells. When exposed to a specialized blue light source during surgery, this metabolite causes the malignant tissue to glow red while healthy tissue appears blue. This allows the surgical team to visually distinguish cancerous cells from surrounding brain tissue.
Details
- Status
- Prescription
- First Approved
- 2017-06-06
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
GLEOLAN Approval History
What GLEOLAN Treats
1 indicationsGLEOLAN is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glioma
GLEOLAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to GLEOLAN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06907485 | STUDY22120058 | Ph 2 | not yet recruiting | A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients |
| NCT05804370 | NXDC-OVA-302 | Ph 3 | recruiting | Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302) |
| NCT04815083 results posted | SBI-CIP 20-002 | Ph 3 | terminated | Fluorescence Imaging of Carcinoma During Breast Conserving Surgery |
| NCT04305470 MEN-301 results posted | NXDC-MEN-301 | Ph 3 | completed | Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma |
| NCT00978081 | CDR0000650536 UPCC-18308, IRB #809093 | Ph 1 | completed | Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors |
| NCT02409732 results posted | D15043 28525 | Ph 4 | completed | Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis |
| NCT00571558 | NCI-2009-00842 NCI-2009-00842, CDR0000579270 | Ph 1 | terminated | Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GLEOLAN FDA Label Details
Indications & Usage
FDA Label (PDF)GLEOLAN is indicated for the treatment of Glioma.
Track GLEOLAN with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.