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oxymetazoline

Trade name: ocuclear

Small moleculeapproved

Approved

May 30, 1986

Oxymetazoline is an adrenergic alpha-agonist, direct acting sympathomimetic, used as a vasoconstrictor to relieve nasal congestion The sympathomimetic action of oxymetazoline constricts the smaller arterioles of the nasal passages, producing a prolonged (up to 12 hours), gentle and decongesting effect. Oxymetazoline elicits relief of conjunctival hyperemia by causing vasoconstriction of superficial conjunctival blood vessels. The drug's action has been demonstrated in acute allergic conjunctivitis and in chemical (chloride) conjunctivitis. Oxymetazoline is self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Oxymetazoline is available over-the-counter as a topical decongestant in the form of oxymetazoline hydrochloride in nasal sprays such as Afrin, Operil, Dristan, Dimetapp, oxyspray, Facimin, Nasivin, Nostrilla, Sudafed OM, Vicks Sinex, Zicam, SinuFrin, and Mucinex Full Force. Due to its vasoconstricting properties, oxymetazoline is also used to treat nose bleeds and eye redness. — NCATS

Clinical trial activity

69 trials · 69 clinical orgs · 11 marketing orgs

Phase 1
15
Phase 2
33
Phase 3
15
Phase 4
16

Earliest trial started Mar 1, 2002 (NCT00223691)

Timeline

1980s

  1. May 30, 1986

    Schering-Plough — Earliest FDA Approval

  2. May 30, 1986

    Bayer — NDA Secondary Org

  3. May 30, 1986

    Schering-Plough — NDA Organization

  4. Mar 31, 1989

    Johnson and Johnson — NDA Secondary Org

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2012

    St. Renatus, LLC — Earliest Phase 3 Sponsor(trial)

  2. Jun 29, 2016

    St. Renatus, LLC — Marketing Organization

  3. Jun 29, 2016

    St. Renatus, LLC — NDA Secondary Org

  4. Jan 18, 2017

    Aclaris Therapeutics, Inc. — NDA Secondary Org

  5. Jan 18, 2017

    Epi Health — Marketing Organization

  6. Jan 18, 2017

    Epi Health — NDA Secondary Org

  7. Jan 18, 2017

    Mayne Pharma — Marketing Organization

2020s

  1. Jul 8, 2020

    Osmotica Pharmaceutical — Marketing Organization

  2. Jul 8, 2020

    Osmotica Pharmaceutical — NDA Secondary Org

  3. Apr 6, 2021

    Taro Pharmaceuticals — Marketing Organization

  4. Oct 4, 2021

    Sun Pharmaceuticals — Marketing Organization

  5. Oct 28, 2022

    Teva — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMay 30, 1986

Chemistry & pharmacology

Loading structure…

SMILES

Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1
Mol. weight
260.38 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 2-(4-tert-butyl-2,6-dimethyl-3-hydroxybenzyl)-2-imidazoline
  • 2-(4-tert-butyl-2,6-dimethyl-3-hydroxybenzyl)-2-imidazoline
  • 3-[(4,5-dihydro-1h-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethylphenol
  • 3-[(4,5-dihydro-1h-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethylphenol
  • 6-t-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol
  • 6-t-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol
  • 6-tert-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol
  • 6-tert-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol
  • afrazine
  • afrazine
  • navasin
  • ocuclear
  • ocuclear
  • ocuclear
  • oximetazoline hcl
  • oximetazoline hcl
  • oximetazolinum
  • oximetazolinum
  • oxylazine
  • oxymatazoline
  • oxymetazolina
  • oxymetazolina
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline
  • oxymetazoline chloride
  • oxymetazoline chloride
  • oxymetazoline hcl
  • oxymetazoline hcl
  • oxymetazoline hcl
  • oxymetazoline hydrochloride
  • oxymetazoline hydrochloride
  • oxymetazoline hydrochloride
  • oxymetazoline hydrochloride
  • oxymetazolinum
  • oxymetazolinum
  • oxymethazoline
  • oxymethazoline
  • oxymethazoline
  • oxymetozoline
  • oxymetozoline
  • rhinofrenol
  • rhinolitan
  • rvl-1201
  • sch-9384
  • sch-9384

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07168148Phase 2Nov 10, 2025Washington University in St. Louis
NCT06911216Early Phase 1 (Phase 1)Mar 17, 2025Santen Inc.
NCT06514612Phase 3Nov 1, 2024Santen Inc.
NCT06683651Phase 3Oct 22, 2024Santen Inc.
NCT06830109Phase 2Oct 15, 2024Washington University in St. Louis
NCT06874244Early Phase 1 (Phase 1)Aug 1, 2024Louisiana State University
NCT05945615Phase 3Jan 31, 2024Pennsylvania State University
NCT06789549Phase 2Jan 1, 2024Padjadjaran University
NCT05715346Phase 1/Phase 2 (Phase 2)Feb 28, 2023Levation Pharma, Ltd.
NCT05556148Phase 4Nov 7, 2022Healeon Medical Inc
NCT06480071N/AJan 13, 2022University of Gothenburg
NCT05006911Phase 1Aug 14, 2021Optall Vision
NCT05001243Phase 1Aug 10, 2021Optall Vision
NCT04831047Phase 4Jun 8, 2021University of Miami
NCT04712799Phase 4Jan 13, 2021Sorlandet Hospital HF
NCT05348148N/AJun 16, 2020Camillians Saint Mary's Hospital Luodong
NCT04104789Phase 2Nov 30, 2019Virginia Commonwealth University
NCT04105985Phase 2Nov 30, 2019Virginia Commonwealth University
NCT03962634Phase 2Aug 31, 2019Virginia Commonwealth University
NCT03954444Phase 3Apr 15, 2019Actavis, Teva
Showing 20 of 69 trials
Page 1 / 4

Organizations

Research & Development (69)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
St. Renatus, LLCFor profit9932008
Rho, Inc.For profit8022008
Triligent InternationalFor profit6022012
Osmotica PharmaceuticalFor profit4422013
AllerganFor profit3322014
Santen Inc.For profit3322024
University of PittsburghAcademic/Hospital3122012
Virginia Commonwealth UniversityAcademic/Hospital3312019
Analytical Bio-Chemistry Laboratories, Inc.For profit2012013
Ground Zero PharmaceuticalsFor profit2012008
ICONFor profit2012007
Louisiana State UniversityAcademic/Hospital2222018
Lumbini Medical CollegeAcademic/Hospital2212018
Mayo ClinicAcademic/Hospital2212013
Ohio State UniversityAcademic/Hospital2222014
Optall VisionFor profit2212021
RDD Pharma LtdFor profit2222014
University of DundeeAcademic/Hospital2212008
University of South FloridaAcademic/Hospital2222005
Washington University in St. LouisAcademic/Hospital2212024
69 organizations
Page 1 / 4

Marketing (16)

OrganizationOrg typeRelationshipDate
Aclaris Therapeutics, Inc.For profitNDA2Jan 18, 2017
BayerFor profitNDA2May 30, 1986
Epi HealthFor profitMKTGJan 18, 2017
Epi HealthFor profitNDA2Jan 18, 2017
Johnson and JohnsonFor profitNDA2Mar 31, 1989
Mayne PharmaFor profitMKTGJan 18, 2017
Osmotica PharmaceuticalFor profitMKTGJul 8, 2020
Osmotica PharmaceuticalFor profitSYNJul 8, 2020
Osmotica PharmaceuticalFor profitNDA2Jul 8, 2020
Schering-PloughFor profitNDAMay 30, 1986
St. Renatus, LLCFor profitMKTGJun 29, 2016
St. Renatus, LLCFor profitNDA2Jun 29, 2016
Sun PharmaceuticalsFor profitMKTGOct 4, 2021
Taro PharmaceuticalsFor profitSYNOct 4, 2021
Taro PharmaceuticalsFor profitMKTGApr 6, 2021
TevaFor profitMKTGOct 28, 2022