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Metvix cream
Metvix cream is a Photosensitizing agent Small molecule drug developed by Galderma R&D. It is currently in Phase 3 development for Actinic keratosis, Basal cell carcinoma (superficial and nodular), Bowen's disease. Also known as: Methyl 5-aminolevulinate hydrochloride.
Metvix (methyl aminolevulinate) is a photosensitizing agent that accumulates in abnormal cells and generates reactive oxygen species when activated by light, destroying target lesions.
Metvix (methyl aminolevulinate) is a photosensitizing agent that accumulates in abnormal cells and generates reactive oxygen species when activated by light, destroying target lesions. Used for Actinic keratosis, Basal cell carcinoma (superficial and nodular), Bowen's disease.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | Metvix cream |
|---|---|
| Also known as | Methyl 5-aminolevulinate hydrochloride |
| Sponsor | Galderma R&D |
| Drug class | Photosensitizing agent |
| Target | Protoporphyrin IX (via aminolevulinic acid pathway) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Metvix is a prodrug that penetrates into cells and is converted to protoporphyrin IX, a photosensitizer. When exposed to red light (630 nm wavelength), it generates singlet oxygen and reactive oxygen species that cause selective destruction of abnormal tissue. This mechanism is used in photodynamic therapy (PDT) for topical treatment of skin lesions.
Approved indications
- Actinic keratosis
- Basal cell carcinoma (superficial and nodular)
- Bowen's disease
Common side effects
- Phototoxic reaction/photosensitivity
- Erythema
- Edema
- Crusting
- Burning sensation
- Pruritus
Key clinical trials
- Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma (PHASE3)
- 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)
- Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia (PHASE2)
- Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease (PHASE4)
- Photodynamic Therapy (PDT) With Metvix® 160 Milligrams/Gram Cream in Organ Transplant Participants With Non-melanoma Skin Cancer (PHASE3)
- Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma (PHASE3)
- Efficacy And Safety Of Illumination Dose Reduction In Red Light Photodynamic Therapy For Actinic Keratoses (NA)
- PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Call Carcinoma (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:
- Metvix cream CI brief — competitive landscape report
- Metvix cream updates RSS · CI watch RSS
- Galderma R&D portfolio CI
Frequently asked questions about Metvix cream
What is Metvix cream?
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Is Metvix cream also known as anything else?
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Related
- Drug class: All Photosensitizing agent drugs
- Target: All drugs targeting Protoporphyrin IX (via aminolevulinic acid pathway)
- Manufacturer: Galderma R&D — full pipeline
- Therapeutic area: All drugs in Dermatology/Oncology
- Indication: Drugs for Actinic keratosis
- Indication: Drugs for Basal cell carcinoma (superficial and nodular)
- Indication: Drugs for Bowen's disease
- Also known as: Methyl 5-aminolevulinate hydrochloride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing