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Xylometazoline

Phase 3

Common Cold | Small molecule | Infectious Disease |Novartis AG|Trials Updated: May 3, 2007

Xylometazoline development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 2007

Xylometazoline target and mechanism

Molecular targetADRA1A, ADRA2A, ADRA2C, ADRA1D, ADRA1B, ADRA2B
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Xylometazoline clinical trials

Xylometazoline · 1 trial · 1 indication

Phase 3 1
NCT00452270Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common ColdCommon Cold
COMPLETED60 Analytics
PHASE3COMPLETED
Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold
Common ColdUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the decongestant effect of xylometazoline in subjects with
common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.

Secondary Endpoints

To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
and duration of relief of nasal obstruction
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
XylometazolineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Over 18 years * Have had moderate common cold symptoms for less than 36 hours. Exclusion Criteria: * Congested/runny nose for more than two continuous weeks in the previous 12 months * Deviated septum or nasal polyps * Recent use of antibiotics * Recent sinusitis Other prot...

Countries:United Kingdom
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Frequently asked questions about Xylometazoline

What is xylometazoline used for?

Xylometazoline is used for the common cold, where it acts as a nasal decongestant. It is a small molecule developed by Novartis AG under the ticker NVS. A Phase 3 trial studied its decongestant effect, timing of effect, and impact on sleep and general well-being in adults with a common cold.

How does xylometazoline work?

Xylometazoline is an agonist at the alpha-adrenergic receptors ADRA1A, ADRA1B, ADRA1D, ADRA2A, ADRA2B, and ADRA2C. By activating these receptors it produces a decongestant effect, which is the basis for its use in the common cold. It is a small molecule in the infectious disease therapeutic area.

Who makes xylometazoline?

Novartis AG, which trades under the ticker NVS, is the developer of xylometazoline. The company ran the Phase 3 clinical program evaluating the drug in subjects with a common cold.

What phase is xylometazoline in?

Xylometazoline is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and is not described as approved by the FDA.

What clinical trials is xylometazoline in?

Xylometazoline has been studied in one Phase 3 trial, NCT00452270, titled Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold. That trial is completed, enrolled 60 participants, was randomized and double blind, and was conducted in the United Kingdom.