{"id":"hal-5-with-illumination","safety":{"commonSideEffects":["Photosensitivity","Local skin reactions","Pain at application site"],"contraindications":["Porphyria","Known hypersensitivity to hexaminolevulinate"]},"_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"Protoporphyrin IX","explanation":"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.","oneSentence":"HAL is converted to protoporphyrin IX in cells, which accumulates preferentially in abnormal tissue and produces reactive oxygen species upon light activation."},"_scrapedAt":"2026-03-28T02:40:43.966Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779122730,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"aminolevulinic acid","brand":"Levulan","company":"DUSA Pharmaceuticals","rationale":"Photodynamic therapy agent for dermatological conditions"},{"name":"methyl aminolevulinate","brand":"Metvix","company":"Galderma","rationale":"Topical photosensitizer for photodynamic therapy"}],"description":"HAL 5% with illumination is a photodynamic therapy developed by Photocure currently in Phase 2 clinical development. The treatment combines a photosensitizing agent (hexaminolevulinate, HAL) at 5% concentration with light activation to selectively destroy abnormal tissue, investigated for dermatological and oncological applications.","indications":{"approved":[{"status":"investigational","condition":"Dermatological conditions","patientPopulation":"Adult, investigational"}]},"trialDetails":[{"nctId":"NCT05962541","phase":"PHASE4","title":"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)","status":"RECRUITING","sponsor":"University of Roma La Sapienza","startDate":"2025-12-22","conditions":"Non-muscle-invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma, High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma","enrollment":327},{"nctId":"NCT02660645","phase":"","title":"Blue Light Cystoscopy With Cysview® Registry","status":"RECRUITING","sponsor":"Photocure","startDate":"2014-04","conditions":"Bladder Cancer","enrollment":4400},{"nctId":"NCT06525571","phase":"PHASE3","title":"Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2024-12-20","conditions":"Bladder Cancer","enrollment":200},{"nctId":"NCT05600322","phase":"PHASE3","title":"Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer","status":"COMPLETED","sponsor":"Photocure","startDate":"2022-11-03","conditions":"Bladder Cancer","enrollment":158},{"nctId":"NCT06548438","phase":"PHASE4","title":"The Impact of PDD During TURB for NMIBC","status":"NOT_YET_RECRUITING","sponsor":"A.O.U. Città della Salute e della Scienza","startDate":"2024-09-01","conditions":"Bladder Cancer","enrollment":300},{"nctId":"NCT03272659","phase":"PHASE2","title":"The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics","status":"WITHDRAWN","sponsor":"Dr. Te Vuong","startDate":"2018-04-01","conditions":"Colorectal Cancer, Photodynamic Diagnosis","enrollment":""},{"nctId":"NCT03058705","phase":"NA","title":"Near Infrared Fluorescence Imaging for Bladder Cancer Detection","status":"COMPLETED","sponsor":"Edward Messing","startDate":"2017-11-28","conditions":"Bladder Cancer","enrollment":10},{"nctId":"NCT02560584","phase":"PHASE3","title":"A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting","status":"COMPLETED","sponsor":"Photocure","startDate":"2015-10-01","conditions":"Bladder Cancer","enrollment":304},{"nctId":"NCT01256424","phase":"PHASE2","title":"Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia","status":"COMPLETED","sponsor":"Photocure","startDate":"2011-04","conditions":"Cervical Intraepithelial Neoplasia","enrollment":262},{"nctId":"NCT00785694","phase":"PHASE4","title":"Recurrence of Bladder Cancer After Transurethral Resection With Hexvix","status":"WITHDRAWN","sponsor":"GE Healthcare","startDate":"2008-12","conditions":"Bladder Cancer","enrollment":""},{"nctId":"NCT00634621","phase":"","title":"Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer","status":"COMPLETED","sponsor":"GE Healthcare","startDate":"2008-02","conditions":"Bladder Cancer","enrollment":283},{"nctId":"NCT00052637","phase":"PHASE3","title":"Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer","status":"COMPLETED","sponsor":"Photocure","startDate":"2001-09","conditions":"Bladder Cancer","enrollment":""},{"nctId":"NCT00233402","phase":"PHASE3","title":"Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy","status":"COMPLETED","sponsor":"Photocure","startDate":"2005-01","conditions":"Bladder Cancer","enrollment":789},{"nctId":"NCT00412971","phase":"PHASE3","title":"A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer","status":"COMPLETED","sponsor":"Photocure","startDate":"2005-04","conditions":"Bladder Cancer","enrollment":233},{"nctId":"NCT00708942","phase":"PHASE2","title":"Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1","status":"TERMINATED","sponsor":"Photocure","startDate":"2009-01","conditions":"Cervical Intraepithelial Neoplasia","enrollment":83},{"nctId":"NCT01551407","phase":"PHASE2","title":"Detection of Bladder Tumors After 30 Min Instillation of Hexvix","status":"TERMINATED","sponsor":"Photocure","startDate":"2011-12","conditions":"Bladder Cancer","enrollment":38}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":15,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"HAL 5% with illumination","genericName":"HAL 5% with illumination","companyName":"Photocure","companyId":"photocure","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}