Aminolevulinate · Gleolan, Levulan Kerastick

What is Aminolevulinate?

Aminolevulinate (ALA) is a porphyrin precursor, formed endogenously in mitochondria from succinyl-CoA and glycine, that leads to accumulation of the metabolite protoporphyrin IX (PpIX) in tumor cells. Its fluorescence under blue light is used to visualize malignant tissue, and under blue light illumination it is used in photodynamic therapy. It is studied in actinic keratosis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Gleolan, Levulan Kerastick

Drug type

Small molecule

Pathways

protoporphyrin IX accumulation, photodynamic activation

Therapy area

Oncology

Developer

Sun Pharm Inds Inc

In trials of

BFRI

FDA status

Approved as Gleolan, Levulan Kerastick (December 3, 1999), NDA020965 · FDA label

✅ FDA-approved uses

• Glioma (Gleolan)
• Actinic keratoses (Levulan Kerastick)

From the indications section of the FDA label (version of Jan 29, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Actinic Keratosis

Sources

• FDA label (DailyMed)
• FDA label Gleolan (2026-01-29), indications
• FDA label Levulan Kerastick (2024-09-12), indications
• ClinicalTrials.gov NCT06027619

Updated Oct 11, 2026.