Drugs / hexaminolevulinate
hexaminolevulinate
also known as
HAL · Hexvix · Cysview · hexaminolevulinate hydrochloride · Cysview kit · HAL hydrochloride · hexaminoavolunate · hexaminolaevulinate · +5 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CYSVIEW KIT | — | 2018-02-15 | fda.gov ↗ |
| Approved | US (FDA) | CYSVIEW KIT | — | 2010-05-28 | fda.gov ↗ |
Trials 18 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02367547 | Mar 2015 → Sep 2018 | basal cell carcinoma | Joint Authority for Päijät-Häme Social and Health Care | Unknown | No outcome recorded |
| Phase 1/2 | NCT01344902 | Feb → Oct 2009 | colon carcinoma | Photocure | Terminated | No outcome recorded |
| Phase 1/2 | NCT00285701 | Jul 2006 → Nov 2007 | colorectal cancer | Photocure | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07669363 | Jul 2026 → Jun 2029 expected | cervical intraepithelial neoplasia, human papilloma virus infection | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03272659 | Apr → Dec 2018 | colorectal cancer | Dr. Te Vuong | Withdrawn | No outcome recorded |
| Phase 2 | NCT01551407 | Dec 2011 → Jun 2012 | urinary bladder cancer | Photocure | Terminated | No outcome recorded |
| Phase 2 | NCT01256424 | Apr 2011 → Sep 2012 | cervical intraepithelial neoplasia | Photocure | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01282515 | Aug 2011 → Oct 2014 | lichen planus | Oslo University Hospital | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06525571 | Dec 2024 → Jan 2027 expected | urinary bladder cancer | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 3 | NCT05600322 | Nov 2022 → Jul 2023 | urinary bladder cancer | Photocure | Completed | No outcome recorded |
| Phase 3 | NCT04484415 | Nov 2020 → Dec 2023 | cervical intraepithelial neoplasia grade 2/3 | Asieris Pharmaceuticals | Unknown | No outcome recorded |
| Phase 3 | NCT02660190 | Feb 2016 → Dec 2017 | urinary bladder cancer | Jørgen Bjerggaard Jensen | Completed | No outcome recorded |
| Phase 3 | NCT02560584 | Oct 2015 → Apr 2017 | urinary bladder cancer | Photocure | Completed | No outcome recorded |
| Phase 3 | NCT00233402 | Jan 2005 → Jul 2008 | urinary bladder cancer | Photocure | Completed | No outcome recorded |
| Phase 3 | NCT00052637 | Sep 2001 → May 2002 | urinary bladder cancer | Photocure | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05962541 | Dec 2025 → Dec 2028 expected | non-invasive bladder urothelial carcinoma | University of Roma La Sapienza | Recruiting | No outcome recorded |
| Phase 4 | NCT00785694 | Dec 2008 → Aug 2011 | urinary bladder cancer | GE Healthcare | Withdrawn | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03058705 | Nov 2017 → Jul 2018 | urinary bladder cancer | Edward Messing | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01050309 Comparator | Nov → Dec 2009 | — | Photocure | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00369018 Comparator | Aug 2006 → Jul 2009 | dysplasia of cervix | Photocure | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00708942 Comparator | Jan 2009 → Jan 2012 | cervical intraepithelial neoplasia | Photocure | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00412971 Comparator | Apr 2005 → Oct 2008 | urinary bladder cancer | Photocure | Completed | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | hexaminolevulinate | “Cevira, an integrated drug-delivery and light-delivery device for hexaminolevulinate photodynamic therapy” PMID 35667715 ↗ Jun 202212“The drug is hexaminolevulinate hydrochloride (HAL) 5% ointment.” NCT07669363 ↗ “hexaminolevulinate (HAL) photodynamic therapy (PDT)” NCT01256424 ↗ |
| Known as | Cysview | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03272659 ↗ |
| Known as | Cysview kit | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201784 ↗ |
| Known as | HAL | “In this study hexaminolevulinate (HAL) will be administered locally as a photosensitiser, using different doses to find the optimal imaging conditions as well as making patient...” NCT00285701 ↗8“This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm).” NCT00369018 ↗ “Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study.” PMID 35750559 ↗ Jun 2022 “using hexaminolaevulinate (HAL: Hexvix®, Photocure, Norway) for photodynamic diagnosis during 12 months of follow-up.” PMID 21414125 ↗ Mar 2011 “Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application” NCT00708942 ↗ “The drug is hexaminolevulinate hydrochloride (HAL) 5% ointment.” NCT07669363 ↗ “selective photosensitizer precursor hexaminolevulinate (HAL)” PMID 18197583 ↗ Jan 2008 “hexaminolevulinate (HAL) photodynamic therapy (PDT)” NCT01256424 ↗ “Drug: hexaminolevulinate (HAL)” NCT01050309 ↗ |
| Known as | HAL hydrochloride | “Patients received 1 or 2 topical treatments of HAL hydrochloride 0.2%, 1%, 5%, and placebo ointment” PMID 25467012 ↗ Oct 2014 |
| Known as | hexaminoavolunate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02660190 ↗ |
| Known as | hexaminolaevulinate | “using hexaminolaevulinate (HAL: Hexvix®, Photocure, Norway) for photodynamic diagnosis during 12 months of follow-up.” PMID 21414125 ↗ Mar 2011 |
| Known as | Hexaminolevulinate HCL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03058705 ↗ |
| Known as | hexaminolevulinate hydrochloride | “The drug is hexaminolevulinate hydrochloride (HAL) 5% ointment.” NCT07669363 ↗ |
| Known as | Hexvix | “reconstituted hexyl 5-aminolevulinate (Hexvix®)” NCT00052637 ↗ |
| Known as | Hexyl aminolevulinate hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201784 ↗ |
| Known as | Hexylaminolevulinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02367547 ↗ |
| Known as | P-1026 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201784 ↗ |
| Known as | P-1206 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201784 ↗ |
| Modality | Diagnostic / imaging agent | “hexaminolevulinate fluorescence cystoscopy” PMID 20850152 ↗ Sep 2010 |
| Modality | Small molecule | — CHEMBL1201784 ↗ |
| Route | Other | “Patients undergo bladder catheterization and instillation of reconstituted hexyl 5-aminolevulinate (Hexvix®).” NCT00052637 ↗ |