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Oxymetazoline 0.05%

Phase 2

Nasal Congestion, Nasal Obstruction | Small molecule | ENT |Bayer AG|Last Updated: Jun 8, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Oxymetazoline 0.05% · 1 trial · 1 indication

Phase 2 1
NCT07582328A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy AdultsNasal Congestion, Nasal Obstruction
COMPLETED120 Analytics
PHASE2COMPLETED
A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults
Nasal Congestion, Nasal ObstructionUnlock trial analytics

Study Endpoints

Primary Endpoints

The change from baseline (CFB) in nasal congestion considered by timepoint and difference over 2 hours post-treatment
From baseline to 2 hours post-administration

Subjective feeling of nasal congestion will be evaluated by the 100 mm Visual Analog Score (VAS) (0-100 mm): 0 being completely clear and 100 being completely obstructed.

Secondary Endpoints

Onset of action: Timed frequency using VAS
From baseline to 2 hours post-administration
The change from baseline in Peak Nasal Inspiratory Flow (PNIF) measurement via nasal peak flow by timepoint and averaged over 2 hours post-treatment
From baseline to 2 hours post-administration
Number of participants with adverse events (AEs), serious adverse events (SAEs), and Treatment Emergent AEs (TEAEs)
From baseline to 2 hours post-administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oxymetazoline HCl 0.05% nasal gel low doseEXPERIMENTALParticipants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Oxymetazoline HCl 0.05% nasal gel intermediate doseEXPERIMENTALParticipants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Oxymetazoline HCl 0.05% nasal gel high doseEXPERIMENTALParticipants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.
Placebo nasal gelPLACEBO_COMPARATORParticipants will self-administer placebo nasal gel, once in each nostril.

Interventions

NameTypeDescription
Oxymetazoline HCl 0.05% nasal gelDRUGSingle dose; intranasally, once in each nostril.
Placebo nasal gelDRUGSingle dose; intranasally, once in each nostril.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants, age between 18 to 65 years at the time of signing the informed consent. * Participants in good general health per medical evaluation (medical, allergy, and social history; physical and nasal examinations). * Participants who self-report acute nasa...

Countries:Canada
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Recent Changes (Last 90 Days)

MEDIUMJul 9, 2026NCT07582328TRIAL_REMOVED: changed
MEDIUMJul 9, 2026NCT07582328TRIAL_REMOVED: changed
MEDIUMJul 9, 2026NCT07582328TRIAL_REMOVED: changed

Frequently asked questions about Oxymetazoline 0.05%

What is Oxymetazoline 0.05% used for?

Oxymetazoline 0.05% is a small molecule being developed for the treatment of nasal congestion and nasal obstruction. It is formulated as a nasal gel and is currently in Phase 2 clinical development. The drug is intended for use in the ear, nose, and throat (ENT) therapeutic area.

Who makes Oxymetazoline 0.05%?

Oxymetazoline 0.05% is being developed by Bayer AG, a company listed on the OTC market under the ticker BAYRY. Bayer is conducting clinical trials to evaluate the efficacy and safety of this nasal gel formulation for nasal congestion and obstruction.

What phase is Oxymetazoline 0.05% in?

Oxymetazoline 0.05% is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, involving 120 participants, to assess how well the drug works and how safe it is.

What clinical trials is Oxymetazoline 0.05% in?

Oxymetazoline 0.05% has one completed Phase 2 clinical trial, identified as NCT07582328. This study, titled 'A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults,' enrolled 120 healthy adult participants in Canada. The trial was randomized, double-blind, and placebo-controlled.

Is Oxymetazoline 0.05% the same as Oxymetazoline HCl 0.05%?

Yes, Oxymetazoline 0.05% is the same as Oxymetazoline HCl 0.05%. The clinical trial NCT07582328 refers to the drug as Oxymetazoline HCl 0.05% nasal gel, confirming that the hydrochloride salt form is the active ingredient in this formulation.