{"entity":{"id":"aminolevulinic-acid","kind":"drug","name":"Aminolevulinic acid (topical, for photodynamic therapy)","aka":["5-ALA","ALA HCl"],"tldr":"Aminolevulinic acid is painted on sun-damaged skin and then activated with a lamp, destroying actinic keratoses before they can become skin cancer; in Europe the gel is also approved for superficial basal cell carcinoma.","summary":"Levulan Kerastick (aminolevulinic acid 20% solution) with BLU-U blue light was approved in December 1999 for actinic keratoses of the face and scalp; Ameluz (10% nanoemulsion gel) with the BF-RhodoLED red lamp followed in May 2016 for lesion- and field-directed treatment of mild to moderate actinic keratosis, on three randomised trials with complete clearance in the majority of patients. The EU authorised Ameluz in 2011 and extended it in 2017 to superficial and nodular basal cell carcinoma unsuitable for surgery. Photodynamic therapy is a field treatment for precancerous skin; pain during illumination and local erythema are expected. Oral aminolevulinic acid (Gleolan) for fluorescence-guided glioma surgery is an imaging agent covered elsewhere.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Aminolevulinic_acid","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=aminolevulinic%20acid"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/aminolevulinicacid"},{"label":"EPAR (Ameluz)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ameluz"},{"label":"Jansen et al., five-year results of a randomised controlled trial comparing photodynamic therapy, topical imiquimod and topical 5-fluorouracil in superficial basal cell carcinoma (J Invest Dermatol 2018)","url":"https://doi.org/10.1016/j.jid.2017.09.033"},{"label":"Cancer Research UK: photodynamic therapy for non-melanoma skin cancer","url":"https://www.cancerresearchuk.org/about-cancer/skin-cancer/treatment/photodynamic-therapy"}],"tags":["nci-list","prevention"],"related":[],"cancers":["cutaneous-scc","basal-cell-carcinoma","skin-cancer"],"sections":[],"technologies":["precancer-ablation"],"targets":[],"drugs":[],"companies":["biofrontera","sun-pharma","photonamic"],"institutions":[],"pathways":[],"terms":["topical-and-destructive-treatment-bcc"],"trials":["nct07225621","nct05736406"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Which photosensitiser the basal cell carcinoma trials used. The randomised comparisons quoted on the basal cell carcinoma page (the Dutch three-arm trial and the Cochrane review) all used methyl aminolevulinate, not 5-aminolevulinic acid, so the five-year tumour-free figure of 62.7 percent and the cosmetic outcomes belong to that cream and are recorded there. Aminolevulinic acid gel is separately approved in the European Union for superficial and nodular basal cell carcinoma as well as for actinic keratosis; the two are not interchangeable in the evidence."],"brand":"Levulan Kerastick / Ameluz","modality":"Topical porphyrin precursor for photodynamic therapy","mechanism":"Taken up by dysplastic keratinocytes and converted to protoporphyrin IX, which on illumination with blue (Levulan) or red (Ameluz) light generates singlet oxygen and destroys the lesion.","approvals":[{"region":"US","year":1999,"indication":"Actinic keratoses of the face and scalp with blue-light photodynamic therapy (Levulan Kerastick)"},{"region":"US","year":2016,"indication":"Mild to moderate actinic keratosis of face and scalp with red-light PDT (Ameluz)"},{"region":"EU","year":2011,"indication":"Actinic keratosis; superficial and nodular basal cell carcinoma added 2017 (Ameluz)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/aminolevulinic-acid/","neighbours":{"cancer":[{"id":"basal-cell-carcinoma","kind":"cancer","name":"Basal cell carcinoma","route":"/cancers/basal-cell-carcinoma/"},{"id":"bowens-disease","kind":"cancer","name":"Bowen's disease (squamous cell carcinoma in situ)","route":"/cancers/bowens-disease/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"},{"id":"skin-cancer","kind":"cancer","name":"Skin cancer (all types)","route":"/cancers/skin-cancer/"}],"technology":[{"id":"photodynamic-therapy-lasers","kind":"technology","name":"Photodynamic therapy lasers and light sources","route":"/technologies/photodynamic-therapy-lasers/"},{"id":"precancer-ablation","kind":"technology","name":"Thermal ablation and cryotherapy for cervical precancer","route":"/technologies/precancer-ablation/"}],"company":[{"id":"biofrontera","kind":"company","name":"Biofrontera","route":"/companies/biofrontera/"},{"id":"photonamic","kind":"company","name":"photonamic","route":"/companies/photonamic/"},{"id":"sbi-pharmaceuticals","kind":"company","name":"SBI Pharmaceuticals","route":"/companies/sbi-pharmaceuticals/"},{"id":"sun-pharma","kind":"company","name":"Sun Pharmaceutical Industries","route":"/companies/sun-pharma/"}],"term":[{"id":"topical-and-destructive-treatment-bcc","kind":"term","name":"Creams, light and cold for basal cell carcinoma","route":"/terms/topical-and-destructive-treatment-bcc/"}],"trial":[{"id":"nct05736406","kind":"trial","name":"A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma","route":"/trials/nct05736406/"},{"id":"nct07225621","kind":"trial","name":"Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma","route":"/trials/nct07225621/"},{"id":"nct02144077","kind":"trial","name":"Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy","route":"/trials/nct02144077/"}],"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-roadmap/"}]}}