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Methyl Aminolaevulinate 16% Cream
Methyl aminolaevulinate is a photosensitizing prodrug that accumulates in abnormal skin cells and generates reactive oxygen species when activated by red light, destroying target lesions.
Methyl aminolaevulinate is a photosensitizing prodrug that accumulates in abnormal skin cells and generates reactive oxygen species upon light activation, destroying target lesions. Used for Actinic keratosis, Basal cell carcinoma (superficial and nodular), Bowen's disease.
At a glance
| Generic name | Methyl Aminolaevulinate 16% Cream |
|---|---|
| Also known as | 160mg/g of methyl aminolevulinate |
| Sponsor | Galderma R&D |
| Drug class | Photosensitizing agent |
| Target | Protoporphyrin IX (via aminolaevulinic acid pathway) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Methyl aminolaevulinate (MAL) is converted to protoporphyrin IX within cells, particularly in dysplastic and malignant keratinocytes. Upon illumination with red light (630 nm wavelength), protoporphyrin IX generates singlet oxygen and free radicals that cause phototoxic damage to treated tissue. This selective accumulation in abnormal cells combined with light activation allows targeted destruction of actinic keratosis and other skin lesions while minimizing damage to surrounding normal tissue.
Approved indications
- Actinic keratosis (non-hyperkeratotic, non-pigmented lesions on face and scalp)
- Basal cell carcinoma (superficial and nodular types)
Common side effects
- Phototoxic reaction (erythema, edema, crusting)
- Burning or stinging sensation during illumination
- Post-inflammatory hyperpigmentation
- Photosensitivity
- Pustules or erosions
Key clinical trials
- Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin (PHASE2)
- PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK (PHASE4)
- Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease (PHASE1)
- Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients (PHASE4)
- Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL (PHASE1, PHASE2)
- Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma (PHASE1)
- Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis (PHASE1)
- Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Basal Cell Carcinoma (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:
- Methyl Aminolaevulinate 16% Cream CI brief — competitive landscape report
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- Galderma R&D portfolio CI