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Levulan (AMINOLEVULINIC ACID)
Levulan accumulates in abnormal skin cells, allowing for visualization and treatment.
Levulan (Aminolevulinic Acid) is a small molecule optical imaging agent originally developed by DUSA and currently owned by Sun Pharm Inds Inc. It was FDA-approved in 1999 for the treatment of actinic keratosis, fluorescent stain, and non-hyperkeratotic actinic keratoses. Levulan works by accumulating in abnormal skin cells, allowing for visualization and subsequent treatment. It has a half-life of 0.83 hours and 60% bioavailability. Levulan is a patented product with no generic manufacturers.
At a glance
| Generic name | AMINOLEVULINIC ACID |
|---|---|
| Sponsor | Sun Pharma |
| Drug class | Optical Imaging Agent |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1999 |
Mechanism of action
Photoactivation following topical application of AMELUZ occurs when aminolevulinic acid (prodrug) is metabolized to protoporphyrin IX (PpIX), photoactive compound which accumulates in the skin. When exposed to red light of suitable wavelength and energy, PpIX is activated resulting in an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are formed which causes damage to cellular components, and eventually destroys the cells. AMELUZ photodynamic therapy of AK lesions utilizes photoactivation of topically applied AMELUZ resulting from BF-RhodoLED or RhodoLED XL illumination, which provides red light of narrow spectrum and light dose of approximately 37 J/cm2.
Approved indications
- Actinic keratosis
- Fluorescent stain
- Non-Hyperkeratotic Actinic Keratoses
Common side effects
- Elevated Liver Enzymes
- Anaphylactic shock
- Angioedema
- Drug eruption
- Urticaria
- Erythema
- Metabolic acidosis
Key clinical trials
- Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions (PHASE2)
- Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma (PHASE2)
- Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT) (NA)
- Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA） (PHASE3)
- Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp (PHASE3)
- Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401) (PHASE1)
- 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (EARLY_PHASE1)
- Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma (EARLY_PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Levulan CI brief — competitive landscape report
- Levulan updates RSS · CI watch RSS
- Sun Pharma portfolio CI