Aminolevulinic Acid · Ameluz, Gleolan

What is Aminolevulinic Acid?

Aminolevulinic acid is a metabolic pro-drug converted into the photosensitizer protoporphyrin IX, which accumulates in cells. Upon exposure to light of appropriate wavelength, it generates singlet oxygen that is cytotoxic to cells. It is used with light in photodynamic therapy for actinic keratosis and as an optical imaging agent in glioma surgery, and is also studied in actinic keratosis and photodamage.

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

At a glance

Also known as

Ameluz, Gleolan, Levulan Kerastick, BF-200

Drug type

Small molecule

Mechanism

Activator

Pathways

heme biosynthesis (ALA to PpIX accumulation), photodynamic reaction generating singlet oxygen and reactive oxygen species

Therapy area

Oncology

Developer

Sun Pharm Inds Inc

In trials of

BFRI

FDA status

Approved as Ameluz, 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 KeratosesActinic KeratosisPhotodamage

Sources

• FDA label (DailyMed)
• FDA label Gleolan (2026-01-29), indications
• FDA label Levulan Kerastick (2024-09-12), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT01966120
• ClinicalTrials.gov NCT02799030
• ClinicalTrials.gov NCT06745999
• ClinicalTrials.gov NCT07053852

Updated Oct 11, 2026.