Hexaminolevulinate
DRACPC ID DRACPC0022
Active Ingredients Hexaminolevulinate
Description The hexyl ester of 5-aminolevulinic acid (ALA) with photodynamic properties. As a precursor of photoactive porphorins, hexyl 5-aminolevulinate induces the endogenous production of the photosensitizer protoporphyrin IX (PPIX) which accumulates selectively in tumor tissue. When exposed to specific wavelengths of light, PPIX is activated and, depending on the wavelength and/or intensity of light, either fluoresces, thereby allowing tumor imaging, or induces tumor cell apoptosis.
Synonyms HAL; HexvixR; hexyl 5-aminolevulinate; Hexaminolevulinate
Type Small Molecule
Disease Bladder Carcinoma
Classification
Amino acid and derivative
Structure Information
Molecular Formula C11H21NO3
Molecular Weight 215.29
Active Sequence Not available
Sequence Length Not available
Modification Not available
IUPAC Name hexyl 5-amino-4-oxopentanoate
InChI InChI=1S/C11H21NO3/c1-2-3-4-5-8-15-11(14)7-6-10(13)9-12/h2-9,12H2,1H3
InChI_Key RYQOILLJDKPETL-UHFFFAOYSA-N
SMILES O=C(OCCCCCC)CCC(CN)=O
External Codes
PubChem CID 6433083
DrugBank Accession Number DB06261
NCI Thesaurus Code C26654
UNII G7H20TKI67 GSRS
CAS 140898-97-1
Drug approval
Drug indication
Hexaminolevulinate is indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.
| Drug Name | Strength | Dosage Form/Route | Company | Marketing Status | Drug ID | Approval year |
|---|---|---|---|---|---|---|
| Cysview Kit | 100mg/vial | For Solution; Intravesical | Photocure Asa | Prescription | NDA: 022555 | 2010 |
| Cysview | 100mg/vial | Powder For Solution; Intravesical | Photocure Asa | Prescription | DIN: 02436639 | 2015 |
| ClinicalTrials.gov Identifier | Title | Condition or disease | Phase | Purpose |
|---|---|---|---|---|
| NCT00285701 | Early Detection of Pre-malignant and Malignant Conditions in the Colon by Means of Fluorescence Endoscopy Using Local and Oral Sensitisation With Hexaminolevulinate (HAL) - a Dose Finding Study | Colorectal Cancer | Phase 1/2 | Diagnostic |
| NCT01256424 | A Randomized Phase II Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low/Moderate-grade Cervical Intraepithelial Neoplasia (CIN1 or 2) | Cervical Intraepithelial Neoplasia | Phase 2 | Treatment |
| NCT00785694 | Recurrence of Bladder Cancer After Transurethral Resection With Hexvix | Bladder Cancer | Phase 4 | Diagnostic |
| NCT00412971 | A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer | Bladder Cancer | Phase 3 | Diagnostic |
| NCT01303991 | A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer | Intermediate or High-risk Bladder Cancer | Phase 1 | Treatment |
More clinical information is obtained from ClinicalTrials.gov.
