Cysview Kit

(hexaminolevulinate)

Small molecule

PPhotocure

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q4 2028

Recruiting

GIST

NCT02660645

Clinical

Trials by Indication[1]

Bladder Cancer6 trials

Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Withdrawn·GGE Healthcare·Phase 4·NCT00785694

Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer

Completed·GGE Healthcare··NCT00634621·283 enrolled

A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting

Completed·PPhotocure·Phase 3·NCT02560584·304 enrolled

Show 3 more trials

Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer

Completed·PPhotocure·Phase 3·NCT00052637

Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

Completed·PPhotocure·Phase 3·NCT05600322·158 enrolled

Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Completed·EEdward Messing·N/A·NCT03058705·10 enrolled

Cervical Intraepithelial Neoplasia1 trial

Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

Terminated·PPhotocure·Phase 2·NCT00708942·83 enrolled

Intravenous Administration1 trial

An Open-label, Single-dose, Three Period Study to Determine the Pharmacokinetic Parameters of Hexaminolevulinate (HAL) Hydrochloride After Vaginal, Enema and Intravenous Administration of Healthy Female Volunteers

Completed·PPhotocure·Phase 1·NCT01050309·8 enrolled

Colon Cancer1 trial

Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study

Completed·PPhotocure·Phase 1/2·NCT00285701·38 enrolled

High Risk1 trial

An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon

Terminated·PPhotocure·Phase 1/2·NCT01344902·13 enrolled

2 more indications

GIST1 trial

Blue Light Cystoscopy With Cysview® Registry

Recruiting·PPhotocure··NCT02660645·4,400 enrolled

Lichen Planus1 trial

Treatment of Female Genital Erosive Lichen Planus(GELP) With Hexaminolevulinate PDT

Completed·OOslo University Hospital·Phase 2/3·NCT01282515·40 enrolled

Regulatory

FDA Approval Timeline[3]

May 28, 2010

CYSVIEW KIT

NDA NDA022555

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for hexaminolevulinate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — hexaminolevulinate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA022555). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Cysview Kit. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Photocure company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: PPhotocure

Patent Landscape[4]

Patent Cliff

Dec 19, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10556010Dec 19, 2036

11311620Dec 19, 2036

11235168Jan 4, 2038