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HAL 0.2% with illumination
HAL 0.2% with illumination is a Photodynamic therapy agent Small molecule drug developed by Photocure. It is currently in Phase 2 development for Actinic keratosis.
Photodynamic therapy with aminolevulinic acid
Photodynamic therapy with aminolevulinic acid Used for Actinic keratosis.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | HAL 0.2% with illumination |
|---|---|
| Sponsor | Photocure |
| Drug class | Photodynamic therapy agent |
| Target | Aminolevulinic acid |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
HAL is a photosensitizer that, upon illumination, generates reactive oxygen species that destroy cancer cells.
Approved indications
- Actinic keratosis
Common side effects
- Skin photosensitivity
- Skin burning sensation
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:
- HAL 0.2% with illumination CI brief — competitive landscape report
- HAL 0.2% with illumination updates RSS · CI watch RSS
- Photocure portfolio CI
Frequently asked questions about HAL 0.2% with illumination
What is HAL 0.2% with illumination?
How does HAL 0.2% with illumination work?
What is HAL 0.2% with illumination used for?
Who makes HAL 0.2% with illumination?
What drug class is HAL 0.2% with illumination in?
What development phase is HAL 0.2% with illumination in?
What are the side effects of HAL 0.2% with illumination?
What does HAL 0.2% with illumination target?
Related
- Drug class: All Photodynamic therapy agent drugs
- Target: All drugs targeting Aminolevulinic acid
- Manufacturer: Photocure — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Actinic keratosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing