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NDL-PDT
NDL-PDT is a Photodynamic therapy agent Small molecule drug developed by Galderma R&D. It is currently in Phase 3 development for Actinic keratosis, Non-melanoma skin cancer. Also known as: Metvix NDL-PDT.
NDL-PDT is a photodynamic therapy agent that generates reactive oxygen species upon light activation to destroy targeted tissue.
NDL-PDT is a photodynamic therapy agent that generates reactive oxygen species upon light activation to destroy targeted tissue. Used for Actinic keratosis, Non-melanoma skin cancer.
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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 | NDL-PDT |
|---|---|
| Also known as | Metvix NDL-PDT |
| Sponsor | Galderma R&D |
| Drug class | Photodynamic therapy agent |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
NDL-PDT (Galderma's proprietary photodynamic therapy formulation) works by combining a photosensitizing agent with light activation to produce cytotoxic reactive oxygen species that damage and destroy diseased cells. This mechanism is particularly suited for dermatological applications where localized light delivery can be precisely controlled. The drug is designed to selectively target and ablate pathological tissue while minimizing damage to surrounding healthy skin.
Approved indications
- Actinic keratosis
- Non-melanoma skin cancer
Common side effects
- Phototoxicity/photosensitivity
- Erythema
- Edema
- Burning/pain at treatment site
- Crusting/scaling
Key clinical trials
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:
- NDL-PDT CI brief — competitive landscape report
- NDL-PDT updates RSS · CI watch RSS
- Galderma R&D portfolio CI
Frequently asked questions about NDL-PDT
What is NDL-PDT?
How does NDL-PDT work?
What is NDL-PDT used for?
Who makes NDL-PDT?
Is NDL-PDT also known as anything else?
What drug class is NDL-PDT in?
What development phase is NDL-PDT in?
What are the side effects of NDL-PDT?
Related
- Drug class: All Photodynamic therapy agent drugs
- Manufacturer: Galderma R&D — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Actinic keratosis
- Indication: Drugs for Non-melanoma skin cancer
- Also known as: Metvix NDL-PDT
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing