NDATOPICALSOLUTION
Approved
Dec 1999
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
7/8 — Comprehensive
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. Approved for skin neoplasms. First approved in 1999.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVULAN (aminolevulinic acid hydrochloride) is a topical photosensitizing agent that converts to protoporphyrin IX in skin tissue, generating cytotoxic singlet oxygen when exposed to blue light. It is used in photodynamic therapy for actinic keratoses and cutaneous squamous cell carcinoma. The drug represents a specialized niche in dermatologic oncology with a mechanistically distinct approach to photochemical cell destruction.
$0.31MPart D
Peak11.7 years to LOEProduct is mature with modest Medicare utilization (595 Part D claims in 2023), indicating a stable but limited market footprint with likely small dedicated team.
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 (1)
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.