Data updated: Mar 10, 2026
NUZOLVENCE
ZOLIFLODACIN
Approved 2025-12-12
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2025-12-12
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION
NUZOLVENCE Approval History
Loading approval history...
What NUZOLVENCE Treats
1 FDA approvalsOriginally approved for its first indication in 2025 .
- Other (1)
🔬
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.
NUZOLVENCE FDA Label Details
ProNUZOLVENCE Patents & Exclusivity
Latest Patent: Jan 2034
Exclusivity: Dec 2035
Patents (6 active)
Exclusivity
NCE
Until Dec 2030
GAIN
Until Dec 2035
Source: FDA Orange Book
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.