Drug intelligence / Profile preview

Ameluz

Development stage
Approved
Lead developer
Biofrontera
Modality
Small Molecules
Administration
Topical
01

Overview

Ameluz (BF-200 ALA) is a topical nanoemulsion gel containing 10% aminolevulinic acid hydrochloride, developed by Biofrontera. It serves as a photosensitizing agent in photodynamic therapy (PDT). Upon topical application, the aminolevulinic acid is absorbed by cells and metabolized through the heme biosynthetic pathway into protoporphyrin IX (PpIX), a potent photosensitizer. When the treated area is subsequently exposed to light of a specific wavelength, the accumulated PpIX is activated, generating reactive oxygen species (ROS) that induce selective destruction of the target tissue. While primarily approved for the treatment of actinic keratosis and basal cell carcinoma, Ameluz has been investigated in a Phase 4 pilot study sponsored by the Joint Authority for Päijät-Häme Social and Health Care for the treatment of lentigo maligna, an in situ form of melanoma, often utilizing hyperspectral imaging for margin determination and laser-assisted delivery to enhance efficacy.

Brand names
Ameluz
Other names
5-aminolevulinic acid nanoemulsionaminolevulinic acid hydrochloride

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