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MAL 16.8% cream
MAL 16.8% cream is a Photodynamic therapy agent Small molecule drug developed by Galderma R&D. It is currently in Phase 3 development for Actinic keratosis (field treatment), Basal cell carcinoma (superficial and nodular). Also known as: CD06809-41.
MAL 16.8% cream is a topical formulation of methyl aminolevulinate that generates reactive oxygen species upon light activation to destroy abnormal skin cells.
MAL 16.8% cream is used to treat Actinic Keratoses, Bowen's Disease, and Keratosis, Actinic, based on clinical trials. The exact mechanism of MAL 16.8% cream is unknown.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | MAL 16.8% cream |
|---|---|
| Also known as | CD06809-41 |
| Sponsor | Galderma R&D |
| Drug class | Photodynamic therapy agent |
| Target | Protoporphyrin IX (photosensitizer) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Methyl aminolevulinate (MAL) is a prodrug that penetrates skin tissue and is converted to protoporphyrin IX, a photosensitizer. When exposed to red light during photodynamic therapy (PDT), protoporphyrin IX generates singlet oxygen and reactive oxygen species that cause selective destruction of target cells, particularly abnormal keratinocytes and dysplastic lesions. This mechanism allows targeted treatment of actinic keratosis and other skin lesions with minimal damage to surrounding healthy tissue.
Approved indications
- Actinic keratosis (field treatment)
- Basal cell carcinoma (superficial and nodular)
Common side effects
- Erythema
- Edema
- Crusting
- Burning sensation
- Photosensitivity
Key clinical trials
- Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease (PHASE4)
- A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study (PHASE3)
- Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face (PHASE3)
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 16.8% cream CI brief — competitive landscape report
- MAL 16.8% cream updates RSS · CI watch RSS
- Galderma R&D portfolio CI
Frequently asked questions about MAL 16.8% cream
What is MAL 16.8% cream?
How does MAL 16.8% cream work?
What is MAL 16.8% cream used for?
Who makes MAL 16.8% cream?
Is MAL 16.8% cream also known as anything else?
What drug class is MAL 16.8% cream in?
What development phase is MAL 16.8% cream in?
What are the side effects of MAL 16.8% cream?
What does MAL 16.8% cream target?
Related
- Drug class: All Photodynamic therapy agent drugs
- Target: All drugs targeting Protoporphyrin IX (photosensitizer)
- Manufacturer: Galderma R&D — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Actinic keratosis (field treatment)
- Indication: Drugs for Basal cell carcinoma (superficial and nodular)
- Also known as: CD06809-41
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing