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HAL 5% with illumination
HAL 5% with illumination is a Photosensitizing agent Small molecule drug developed by Photocure. It is currently in Phase 2 development.
HAL is converted to protoporphyrin IX in cells, which accumulates preferentially in abnormal tissue and produces reactive oxygen species upon light activation.
HAL 5% is a small molecule intervention used in the treatment of bladder cancer. It is administered as part of a fluorescence cystoscopy procedure, specifically in combination with Hexvix, to aid in the detection and early recurrence of bladder cancer.
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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).
| 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 5% with illumination |
|---|---|
| Sponsor | Photocure |
| Drug class | Photosensitizing agent |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
Hexaminolevulinate (HAL) is a prodrug that enters cells and is metabolized through the heme biosynthesis pathway to protoporphyrin IX (PpIX). PpIX accumulates preferentially in rapidly dividing or abnormal cells. Upon illumination with specific wavelength light, PpIX generates reactive oxygen species that cause selective photodynamic destruction of target tissue.
Approved indications
Common side effects
Key clinical trials
- Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) (PHASE4)
- Blue Light Cystoscopy With Cysview® Registry
- Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection (PHASE3)
- Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer (PHASE3)
- The Impact of PDD During TURB for NMIBC (PHASE4)
- The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PHASE2)
- Near Infrared Fluorescence Imaging for Bladder Cancer Detection (NA)
- A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting (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:
- HAL 5% with illumination CI brief — competitive landscape report
- HAL 5% with illumination updates RSS · CI watch RSS
- Photocure portfolio CI
Frequently asked questions about HAL 5% with illumination
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Related
- Drug class: All Photosensitizing agent drugs
- Manufacturer: Photocure — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing