Overview
Hexaminolevulinate is an optical imaging drug. In solution form it is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. On May 28, 2010, the U.S. Food and Drug Administration (FDA) granted approval for hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Hexaminolevulinate is manufactured under the brand Cysview® by Photocure ASA. In Europe, Hexaminolevulinate is marketed under the brand Hexvix®.
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.
Associated Conditions
- Bladder Carcinoma
- Carcinoma in situ of urinary bladder
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/29 | Phase 3 | Recruiting | |||
2023/07/27 | Phase 4 | Not yet recruiting | University of Roma La Sapienza | ||
2022/10/31 | Phase 3 | Completed | Photocure | ||
2017/09/05 | Phase 2 | Withdrawn | Dr. Te Vuong | ||
2017/02/23 | Not Applicable | Completed | Edward Messing | ||
2016/01/21 | N/A | Recruiting | Photocure | ||
2015/09/25 | Phase 3 | Completed | Photocure | ||
2011/04/29 | Phase 1 | Terminated | Photocure | ||
2011/01/25 | Phase 2 | Completed | Oslo University Hospital | ||
2010/01/15 | Phase 1 | Completed | Photocure |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution vial plus diluent vial | 318359 | Medicine | A | 4/7/2020 |
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