TheraRadar
Data updated: Jun 28, 2026

OXYMETAZOLINE HYDROCHLORIDE · SUN PHARMA CANADA

Generic · see RHOFADE Trial Activity: Declining
Dermatology Approved 1986-05-30

Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies shrinks swollen nasal membranes so you can breathe more freely

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Padagis LLC conducting 1 trials (13%)
12 indications explored (Broad Platform)
→ allergic rhinitis (2 trials)
→ rosacea (1 trials)
→ erythema (1 trials)
NDA
Small Molecule
1
Indication
--
Phase 3 Trials
40
Years on Market

Details

Status
Prescription
First Approved
1986-05-30
Routes
TOPICAL
Dosage Forms
CREAM

Companies

SUN PHARMA CANADA
Active Ingredient: OXYMETAZOLINE HYDROCHLORIDE

OXYMETAZOLINE HYDROCHLORIDE Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
Oct 2021 ORIGINAL
Update
FDA Letter

What OXYMETAZOLINE HYDROCHLORIDE Treats

2 indications

OXYMETAZOLINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as RHOFADE (same active ingredient).

Source: FDA Label
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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"
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

Indications & Usage

Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies shrinks swollen nasal membranes so you can breathe more freely

Looking for the branded version?

RHOFADE

Full clinical data, patents, trials, and competitive landscape for oxymetazoline hydrochloride.

See RHOFADE

Data Sources

FDA Approval: ANDA213584 → Label: DailyMed (2024-12-26) → Trials: ClinicalTrials.gov →

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