Active Ingredient History
Aminolevulinic Acid is the first compound in the porphyrin synthesis pathway. The metabolism of aminolevulinic acid (ALA) is the first step in the biochemical pathway resulting in heme synthesis. Aminolevulinic acid is not a photosensitizer, but rather a metabolic precursor of protoporphyrin IX (PpIX), which is a photosensitizer. The synthesis of ALA is normally tightly controlled by feedback inhibition of the enzyme, ALA synthetase, presumably by intracellular heme levels. ALA, when provided to the cell, bypasses this control point and results in the accumulation of PpIX, which is converted into heme by ferrochelatase through the addition of iron to the PpIX nucleus. Marketed under the brand name LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator, it is indicated for the treatment of minimally to moderately thick actinic keratoses (Grade 1 or 2, see table 2 for definition) of the face or scalp. Aminolevulinic acid is also being studied in the treatment of other conditions and types of cancer. An orally-administered in vivo diagnostic agent, Aminolevulinic acid, is used in photodynamic diagnosis (PDD) whose aim is to help doctors visualize the tumor tissue during surgical resection of malignant glioma, it is already sold in over 20 European countries including Germany and the U.K. According to the presumed mechanism of action, photosensitization following application of aminolevulinic acid (ALA) topical solution occurs through the metabolic conversion of ALA to protoporphyrin IX (PpIX), which accumulates in the skin to which aminolevulinic acid has been applied. When exposed to light of appropriate wavelength and energy, the accumulated PpIX produces a photodynamic reaction, a cytotoxic process dependent upon the simultaneous presence of light and oxygen. The absorption of light results in an excited state of the porphyrin molecule, and subsequent spin transfer from PpIX to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals. Photosensitization of actinic (solar) keratosis lesions using aminolevulinic acid, plus illumination with the BLU-UTM Blue Light Photodynamic Therapy Illuminator (BLU-U), is the basis for aminolevulinic acid photodynamic therapy (PDT). NCATS
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
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| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Acne Vulgaris (Phase 3)
Arthroscopy (Phase 3)
Astrocytoma (Phase 2)
Basal Cell Nevus Syndrome (Phase 2)
Brain Neoplasms (Phase 3)
Breast Neoplasms (Phase 3)
Carcinoma, Basal Cell (Phase 4)
Carcinoma in Situ (Phase 1)
Cervical Intraepithelial Neoplasia (Phase 2)
Cheilitis (Phase 4)
Colitis, Ulcerative (Phase 4)
Colonic Neoplasms (Phase 1/Phase 2)
Coronavirus Infections (Phase 2)
COVID-19 (Phase 2)
Crohn Disease (Phase 1/Phase 2)
Dermatology (Phase 4)
Drug Evaluation (Phase 2)
Erythrocytes, Abnormal (Phase 2)
General Surgery (Phase 3)
Genetic Diseases, Inborn (Phase 2)
Glioblastoma (Phase 3)
Glioma (Phase 3)
Gliosarcoma (Phase 2)
Graft vs Host Disease (Phase 1/Phase 2)
Head and Neck Neoplasms (Phase 1)
Healthy Volunteers (Phase 1)
Human papillomavirus 16 (Phase 2)
Hutchinson's Melanotic Freckle (Phase 4)
Keratosis (Phase 1)
Keratosis, Actinic (Phase 4)
Lesch-Nyhan Syndrome (Phase 2)
Leukemia (Phase 2)
Leukoplakia (Phase 3)
Leukoplakia, Oral (Phase 1)
Lichens (Phase 3)
Low-Level Light Therapy (Phase 4)
Lung Neoplasms (Phase 1)
Lymphoma (Phase 2)
Lymphoma, T-Cell (Phase 1/Phase 2)
Malaria (Phase 2)
Melanoma (Phase 2)
Meningioma (Phase 3)
Mouth Neoplasms (Phase 1/Phase 2)
Mycosis Fungoides (Phase 2)
Neoplasms (Phase 2)
Neoplasms, Basal Cell (Phase 2)
Neurofibromatoses (Phase 1)
Neurofibromatosis 1 (Phase 2)
Oligodendroglioma (Phase 1)
Onychomycosis (Phase 2)
Papillomavirus Infections (Phase 2)
Photochemotherapy (Phase 1/Phase 2)
Photosensitizing Agents (Phase 1/Phase 2)
Phototherapy (Phase 3)
Postoperative Complications (Phase 3)
Precancerous Conditions (Phase 2)
Protoporphyrins (Early Phase 1)
Rosacea (Phase 4)
Severe Acute Respiratory Syndrome (Phase 2)
Skin Neoplasms (Phase 4)
Skull Base Neoplasms (Phase 2)
Squamous Intraepithelial Lesions (Phase 2)
Urinary Bladder Neoplasms (Phase 3)
| Trial | Phase | Start Date | Organizations | Indications |
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