Data updated: May 26, 2026
Adstiladrin (nadofaragene firadenovec-vncg)
Approved 2022-12-15
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2022-12-15
- Patent Cliff
- 2034
- Routes
- Intravesical
- Dosage Forms
- For Suspension
Adstiladrin Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2022 to 2022
Dec 2022 ORIGINAL
Update · CBER biologic (Purple Book)
What Adstiladrin Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 2022)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02773849 results posted | rAd-IFN-CS-003 000418 | Ph 3 | completed | ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
Adstiladrin FDA Label Details
Track Adstiladrin 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.