NDATOPICALSOLUTION
Approved
Dec 1999
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
6/8 — Strong
LEVULAN (aminolevulinic acid hydrochloride) by PharmaIN is solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin ix (ppix), a photosensitizer, which accumulates in the skin. First approved in 1999.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVULAN is a topical aminolevulinic acid hydrochloride solution approved for photodynamic therapy of actinic keratoses. The drug works by converting to protoporphyrin IX, a photosensitizer that accumulates in skin lesions and generates cytotoxic reactive oxygen species when exposed to blue light (BLU-U illuminator). Treatment combines topical application with controlled light exposure to destroy precancerous skin lesions.
$0.31MPart D
Peak11.3 years to LOEMature product at peak lifecycle with modest Medicare claims volume; limited commercial growth opportunity and likely stable, smaller team size.
Mechanism of Action
solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin IX (PpIX), a photosensitizer, which accumulates in the skin. When exposed to light of appropriate wavelength and energy, the accumulated photoactive porphyrins produce a photodynamic…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
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
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
Started Sep 2019
0Malaria
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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.