OXYMETAZOLINE HYDROCHLORIDE
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2021-10-04
- Routes
- TOPICAL
- Dosage Forms
- CREAM
OXYMETAZOLINE HYDROCHLORIDE Approval History
What OXYMETAZOLINE HYDROCHLORIDE Treats
1 FDA approvalsOriginally approved for its first indication in 2021 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 2021)Letter
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02630121 | PRO00001844 | Ph 4 | recruiting | Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea |
| NCT03954444 results posted | OXY2018-01 | Ph 3 | completed | A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream" |
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.
OXYMETAZOLINE HYDROCHLORIDE FDA Label Details
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RHOFADE
Full clinical data, patents, trials, and competitive landscape for oxymetazoline hydrochloride.
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