VISTIDE (cidofovir)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1996-06-26
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
VISTIDE Approval History
What VISTIDE Treats
2 FDA approvalsOriginally approved for its first indication in 1996 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jun 1996)
- • Approved indication (Mar 1999)Label
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07387367 ENOVIA | BCV-PA02 | Ph 3 | recruiting | A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT |
| NCT01295645 | 2010-0518 NCI-2011-00250 | Ph 2 | active not recruiting | Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis |
| NCT02931539 results posted | SHP620-303 2015-004725-13 | Ph 3 | completed | Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir |
| NCT02567149 | Version 1.0 | Ph 2 | withdrawn | Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population. |
| NCT01816646 | 2012-0903 NCI-2013-02184 | Ph 1 | completed | Intravesical Cidofovir for Hemorrhagic Cystitis |
| NCT02976987 | CHUB-POST-Colvir II | Ph 2 | completed | A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions. |
| NCT02515877 HPV-RX | 2007-005505-21 2007/1297 | Ph 1 | completed | Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VISTIDE FDA Label Details
Track VISTIDE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment