NDATOPICALGEL
Approved
May 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
AMELUZ (aminolevulinic acid hydrochloride) by Biofrontera is (prodrug) is metabolized to protoporphyrin ix (ppix), a photoactive compound which accumulates in the skin. First approved in 2016.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMELUZ is a topical gel containing aminolevulinic acid hydrochloride, a prodrug that converts to protoporphyrin IX in skin tissue. It is indicated for actinic keratosis (AK) treatment via photodynamic therapy, where red light activation generates reactive oxygen species that destroy diseased cells. The product requires specialized LED illumination (BF-RhodoLED or RhodoLED XL) for photoactivation.
Peak17.2 years to LOE
Product is at peak commercial stage with stable market position; brand team likely operates at full capacity with focus on market penetration and durability strategies.
Mechanism of Action
(prodrug) is metabolized to protoporphyrin IX (PpIX), a photoactive compound which accumulates in the skin. When exposed to red light of a suitable wavelength and energy, PpIX is activated resulting in an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage
Started Jun 2025
10 enrolled
Actinic KeratosesPhotodamage
Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)
Started Apr 2025
144 enrolled
5-aminolevulinic AcidFluorescence-guided Resection
Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp
Started Dec 2022
172 enrolled
Actinic Keratoses
Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults
Started Dec 2021
120 enrolled
Acne Vulgaris
Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp
Started Dec 2021
112 enrolled
Actinic KeratosisKeratosis, ActinicKeratosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.