Last reviewed · How we verify
MAL
MAL (methyl aminolevulinate) is a photosensitizing prodrug that accumulates in abnormal cells and generates reactive oxygen species when activated by red light, destroying target tissue.
MAL (methyl aminolevulinate) is a photosensitizing agent that accumulates in abnormal cells and, when activated by red light, generates reactive oxygen species to destroy target tissue. Used for Actinic keratosis, Basal cell carcinoma, Bowen's disease.
At a glance
| Generic name | MAL |
|---|---|
| Also known as | CD06809-41, methylaminolevulinic acid, Metvix, methyl aminolevulinate, Metvix® (Galderma) |
| Sponsor | Photocure |
| Drug class | Photosensitizing agent |
| Target | Protoporphyrin IX (via aminolevulinic acid pathway) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
MAL is converted intracellularly to protoporphyrin IX, a photosensitizer that localizes preferentially in dysplastic and malignant cells. Upon illumination with red light (typically 630 nm wavelength), it generates singlet oxygen and free radicals that cause direct cell death and vascular damage. This photodynamic therapy (PDT) approach selectively destroys abnormal tissue while sparing surrounding normal tissue.
Approved indications
- Actinic keratosis (non-hyperkeratotic, non-pigmented lesions on face and scalp)
- Basal cell carcinoma (superficial and nodular)
- Bowen's disease (squamous cell carcinoma in situ)
Common side effects
- Phototoxic reaction / photosensitivity
- Erythema and edema at treatment site
- Burning and stinging sensation during illumination
- Post-inflammatory hyperpigmentation
- Crusting and erosion
- Scarring (rare)
Key clinical trials
- Novel Coding Strategies for Children With Cochlear Implants (NA)
- DevRobust Treatment for Mal de Débarquement Syndrome (NA)
- Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma (PHASE3)
- Optokinetic Stimulation in Mal de Debarquement Syndrome: Case Report (NA)
- Indoor Daylight Photodynamic Therapy is an Effective, First-line Treatment for AK, But Its Feasibility is Limited by the Time Required for the Illumination (2 Hours). Our Objective Was to Evaluate the Efficacy of Idl-PDT With an Illumination Time of 1 Hour Versus 2 Hours in the Treatment of Scalp AK (NA)
- A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis. (PHASE1, PHASE2)
- Phase II Clinical Clical of the Pure Protein Derivatives of BCG (PHASE1)
- Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease (PHASE4)
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:
- MAL CI brief — competitive landscape report
- MAL updates RSS · CI watch RSS
- Photocure portfolio CI