QLONILIK (clonidine hydrochloride) · CMP DEV LLC
QLONILIK is FDA-approved to treat 4 conditions (same as DURACLON).
Details
- Status
- Prescription
- First Approved
- 2026-07-29
- Routes
- ORAL
- Dosage Forms
- SOLUTION
QLONILIK Approval History
What QLONILIK Treats
4 indicationsQLONILIK is approved for 4 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cancer
- Neuropathic Pain
- Somatic Pain
- Visceral Pain
Same approved indications as DURACLON (same active ingredient).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01439126 results posted | SHN-KAP-401 | Ph 4 | completed | Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder |
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.
QLONILIK FDA Label Details
Indications & Usage
FDA Label (PDF)QLONILIK is FDA-approved to treat 4 conditions — same approved indications as DURACLON.
Track QLONILIK 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.