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aminolevulinic acid (ALA)
Aminolevulinic acid is a precursor to protoporphyrin IX, which accumulates in cells and generates reactive oxygen species when activated by light, enabling photodynamic therapy.
Aminolevulinic acid is a precursor to protoporphyrin IX, which accumulates in cells and generates reactive oxygen species when activated by light, enabling photodynamic therapy. Used for Actinic keratosis (photodynamic therapy), Non-melanoma skin cancer (photodynamic therapy), Glioblastoma (intraoperative fluorescence-guided surgery).
At a glance
| Generic name | aminolevulinic acid (ALA) |
|---|---|
| Also known as | LEVULAN® KERASTICK®, Levulan Kerastick, Levulan Kerastick applicator, Levulan |
| Sponsor | University of California, Davis |
| Drug class | Photosensitizer |
| Target | Protoporphyrin IX (endogenous photosensitizer generated from ALA) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
ALA is converted intracellularly to protoporphyrin IX (PpIX), a photosensitizer that accumulates preferentially in rapidly dividing and abnormal cells. Upon exposure to specific wavelengths of light, PpIX generates singlet oxygen and other reactive oxygen species that cause direct cell death and vascular damage, making it useful for both diagnostic fluorescence imaging and therapeutic photodynamic therapy.
Approved indications
- Actinic keratosis (photodynamic therapy)
- Non-melanoma skin cancer (photodynamic therapy)
- Glioblastoma (intraoperative fluorescence-guided surgery)
Common side effects
- Photosensitivity/skin phototoxicity
- Burning or stinging at treatment site
- Erythema and edema
- Post-inflammatory hyperpigmentation
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)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- aminolevulinic acid (ALA) CI brief — competitive landscape report
- aminolevulinic acid (ALA) updates RSS · CI watch RSS
- University of California, Davis portfolio CI