GANZYK-RTU (ganciclovir)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2017-02-17
- Patent Cliff
- 2034
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
GANZYK-RTU Approval History
What GANZYK-RTU Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05578820 | NTI1GSA | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid |
| NCT03699254 CYTOCOR | CYTOCOR 2018-003300-39 | Ph 3 | completed | Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients. |
| NCT03004261 | CMV-CTL-201609 | Ph 4 | completed | CMV-CTL for the Treatment of CMV Infection After HSCT |
| NCT02152358 PTH | 20126003312-30 2012-003312-30 | Ph 4 | completed | PTH - Preemptive Treatment for Herpesviridae |
| 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 |
| NCT01185223 CONVINCE | ML 22371 | Ph 3 | terminated | Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation |
| NCT00917826 | P2 L-D AB | Ph 2 | terminated | Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies |
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.
GANZYK-RTU FDA Label Details
GANZYK-RTU Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for GANZYK-RTU
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 1 active patents
Trial Analysis
- • 7 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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