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Oxymetazoline

Generic Name
Oxymetazoline
Brand Names
Afrin, Dristan 12-hour Nasal Spray, Kovanaze, Nostrilla, Rhofade, Sinex Long-acting, Upneeq, Zicam Sinus Relief
Drug Type
Small Molecule
Chemical Formula
C16H24N2O
CAS Number
1491-59-4
Unique Ingredient Identifier
8VLN5B44ZY
Background

Oxymetazoline is an imidazole derivative and a potent, direct-acting alpha (α)-adrenergic agonist with affinity to both α- and α-adrenoceptors. Oxymetazoline is available in various formulations with a wide variety of clinical implications. The topical formulation of the drug is used to treat persistent facial redness in adults. As an effective decongestant, oxymetazoline is available in over-the-counter intranasal sprays used to relieve nasal and sinus congestion caused by a wide variety of conditions, such as common cold, hay fever, and upper respiratory allergies. In dentistry, oxymetazoline and tetracaine combination intranasal spray (Kovanaze) is used for regional anesthesia during dental procedures in children and adults. In July 2020, the FDA approved the use of an ophthalmic formulation of oxymetazoline (Upneeq) in adults with acquired blepharoptosis, or ptosis, making it the first FDA-approved medical treatment for this medical condition.

Indication

Oxymetazoline is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

Ophthalmic oxymetazoline is indicated for the treatment of acquired blepharoptosis in adults.

When used in combination with tetracaine intranasally, oxymetazoline is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

Oxymetazoline can be found in over-the-counter nasal products as a nasal decongestant.

For off-label uses, oxymetazoline has been used during nasal intubation and during ear, nose, and throat surgery to improve visualization of the airway and to minimize post-operative bleeding.

Associated Conditions
Acquired Blepharoptosis, Allergic Rhinitis (AR), Nasal Congestion, Postoperative Hemorrhages, Rhinorrhoea, Sinus Congestion, Acute Rhinitis, Persistent facial erythema
Associated Therapies
Airway visualization

Intra-anal Oxymetazoline in Healthy Adult Volunteers

Phase 1
Conditions
Fecal Incontinence
Interventions
First Posted Date
2018-05-18
Last Posted Date
2022-08-02
Lead Sponsor
RDD Pharma Ltd
Target Recruit Count
40
Registration Number
NCT03529487
Locations
🇺🇸

Spaulding Clinical Research, LLC, West Bend, Wisconsin, United States

An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea

Phase 3
Completed
Conditions
Rosacea
Erythema
Interventions
First Posted Date
2017-11-24
Last Posted Date
2021-11-08
Lead Sponsor
Padagis LLC
Target Recruit Count
50
Registration Number
NCT03352323
Locations
🇺🇸

J&S Studies, College Station, Texas, United States

Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery

Phase 4
Completed
Conditions
Endoscopic Sinus Surgery
Nasal Polyps
Interventions
First Posted Date
2017-07-25
Last Posted Date
2021-01-13
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
20
Registration Number
NCT03228914
Locations
🇺🇸

The University of Texas Health Science Center at Houston, Houston, Texas, United States

A Study of Nasal Glucagon in Participants With a Common Cold

Phase 1
Completed
Conditions
Common Cold
Interventions
First Posted Date
2016-05-19
Last Posted Date
2019-09-18
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
36
Registration Number
NCT02778100
Locations
🇨🇦

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mount-Royal, Quebec, Canada

Efficacy and Safety of Pediatric Drugs in Nasal Congestion

Phase 3
Completed
Conditions
Nasal Congestion
Interventions
Drug: Naridrin
Drug: Afrin
First Posted Date
2015-11-10
Last Posted Date
2019-10-16
Lead Sponsor
EMS
Target Recruit Count
292
Registration Number
NCT02601235
Locations
🇧🇷

Faculdade de Medicina do ABC, Santo André, SP, Brazil

Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Not Applicable
Completed
Conditions
Adenoidectomy
Functional Endoscopic Sinus Surgery (FESS)
Turbinate Surgery
Interventions
First Posted Date
2015-05-27
Last Posted Date
2018-09-18
Lead Sponsor
Richard Cartabuke
Target Recruit Count
30
Registration Number
NCT02453841
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Phase 2
Withdrawn
Conditions
Dental Anesthesia
Nasal Surgical Procedures
Intranasal Drug Administration
Interventions
First Posted Date
2014-02-14
Last Posted Date
2015-08-07
Lead Sponsor
Richard Cartabuke
Registration Number
NCT02062996
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

NoAL (HPMC) in Combination With Oxymetazoline in Patients With Allergic Rhinitis

Phase 2
Completed
Conditions
Allergic Rhinitis
Interventions
Drug: Oxymetazoline
Other: Hydroxyl-propyl-methyl cellulose powder
Other: Placebo (lactose powder)
First Posted Date
2013-11-18
Last Posted Date
2015-09-23
Lead Sponsor
Association Asthma, Bulgaria
Target Recruit Count
40
Registration Number
NCT01986582
Locations
🇧🇬

Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma, Sofia, Bulgaria

TransMEM Gas Exchange -- Project 1, Aim 2

Phase 1
Completed
Conditions
Middle Ear Disease
Nasal Allergy
Interventions
Biological: ragweed
Biological: histamine
Drug: pseudoephedrine
Drug: Oxymetazoline
First Posted Date
2013-08-20
Last Posted Date
2020-02-07
Lead Sponsor
Cuneyt M. Alper
Target Recruit Count
84
Registration Number
NCT01925729
Locations
🇺🇸

Middle Ear Physiology Laboratory, University of PIttsburgh, Pittsburgh, Pennsylvania, United States

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