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BF-200

Small molecule · developed by Biofrontera Bioscience GmbH

Phase 3 Most advanced trial (none active)

BFRI Developer

2 Registered trials

What is BF-200?

BF-200 (Ameluz) is a topical nanoemulsion gel containing 5-aminolevulinic acid, a precursor that is converted inside skin cells to the photosensitizer protoporphyrin IX. Light of the proper wavelength activates protoporphyrin IX to generate singlet oxygen, causing local cytotoxicity. It is studied in photodynamic therapy for basal cell carcinoma and actinic keratosis.

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

At a glance

Also known as: Ameluz
Drug type: Small molecule
Pathways: protoporphyrin IX photosensitization, singlet oxygen generation, cytotoxic effect on lesion cells
Therapy area: Oncology
Developer: Biofrontera Bioscience GmbH (BFRI)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 3

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT02144077	Phase 3	Basal Cell Carcinoma (BCC)	Completed	BFRI
NCT02799030	Phase 2	Actinic Keratosis	Completed	BFRI

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

Conditions studied

Actinic KeratosisBasal Cell Carcinoma (BCC)

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the BFRI page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z