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Drug ReportsOxymetazoline
Oxymetazoline
Kovanaze, Rhofade, Upneeq, Visine (oxymetazoline) is a small molecule pharmaceutical. Oxymetazoline was first approved as Ocuclear on 1986-05-30. It is used to treat common cold, conjunctivitis, rhinitis, and sinusitis in the USA. The pharmaceutical is active against alpha-1A adrenergic receptor and alpha-2A adrenergic receptor. In addition, it is known to target 5-hydroxytryptamine receptor 1D, 5-hydroxytryptamine receptor 1B, alpha-2C adrenergic receptor, alpha-1B adrenergic receptor, 5-hydroxytryptamine receptor 2C, alpha-1D adrenergic receptor, and alpha-2B adrenergic receptor.
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5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
eye diseasesD005128
Trade Name
FDA
EMA
Rhofade, Upneeq, Visine (discontinued: Ocuclear, Oxymetazoline)
Combinations
Kovanaze
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Oxymetazoline hydrochloride
Tradename
Company
Number
Date
Products
VISINE L.R.Johnson & JohnsonN-019407 OTC1989-03-31
1 products, RLD, RS
RHOFADEMayne GroupN-208552 RX2017-01-18
1 products, RLD, RS
UPNEEQRVL PharmaceuticalsN-212520 RX2020-07-08
1 products, RLD, RS
Show 1 discontinued
Oxymetazoline hydrochloride
+
Tetracaine hydrochloride
Tradename
Company
Number
Date
Products
KOVANAZESt RenatusN-208032 RX2016-06-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
7 select original nasalOTC monograph final2019-11-14
afrinC2002632024-12-06
afrin allergy sinus nasalC2002632024-12-06
afrin no dripC2002632024-12-06
afrin no drip nightC2002632024-12-06
afrin no-dripC2002632024-12-06
afrin nodrip allergy sinus nightC2002632024-12-06
afrin originalC2002632024-12-18
afrin original nasalC2002632023-11-05
anefrin nasalC2002632024-09-07
Show 126 more
Agency Specific
FDA
EMA
Expiration
Code
OXYMETAZOLINE HYDROCHLORIDE, UPNEEQ, RVL PHARMS
2023-07-08NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Oxymetazoline Hydrochloride, Upneeq, Rvl Pharms
107994812039-12-16U-2849
108140012039-12-16DP
108985732039-12-16DP
109401382039-12-16U-2849
111034822039-12-16DP
113115152039-12-16DP
113247222039-12-16U-2849
115410362039-12-16DP
83577142031-08-26U-2849
98678082031-08-26U-2849
109127652031-08-26U-2849
Oxymetazoline Hydrochloride, Rhofade, Mayne Pharma
99747732035-06-11U-2306
103353912035-06-11U-2567
107513252035-06-11U-2921
115175602035-06-11U-3494
88838382031-12-01DP
78120492028-05-02U-1959
84206882024-08-02U-1959
88159292024-01-22U-1959
Oxymetazoline Hydrochloride / Tetracaine Hydrochloride, Kovanaze, St Renatus
85802822030-04-02DPU-1876
93081912030-04-02DPU-1876
ATC Codes
D: Dermatologicals
— D11: Other dermatological preparations in atc
— D11A: Other dermatological preparations in atc
— D11AX: Other dermatological preparations in atc
— D11AX27: Oxymetazoline
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AA: Sympathomimetics, plain
— R01AA05: Oxymetazoline
— R01AB: Sympathomimetics, combinations excl. corticosteroids
— R01AB07: Oxymetazoline
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GA: Sympathomimetics used as decongestants
— S01GA04: Oxymetazoline
HCPCS
No data
Clinical
Clinical Trials
785 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD013810——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOxymetazoline
INNoxymetazoline
Description
Oxymetazoline is a member of the class of phenols that is 2,4-dimethylphenol which is substituted at positions 3 and 6 by 4,5-dihydro-1H-imidazol-2-ylmethyl and tert-butyl groups, respectively. A direct-acting sympathomimetic with marked alpha-adrenergic activity, it is a vasoconstrictor that is used (generally as the hydrochloride salt) to relieve nasal congestion. It has a role as an alpha-adrenergic agonist, a sympathomimetic agent, a nasal decongestant and a vasoconstrictor agent. It is a member of phenols, a carboxamidine and a member of imidazolines. It is a conjugate base of an oxymetazoline(1+).
Classification
Small molecule
Drug classantihistamines/local vasoconstrictors (antazoline type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1
Identifiers
PDB—
CAS-ID1491-59-4
RxCUI—
ChEMBL IDCHEMBL762
ChEBI ID7862
PubChem CID4636
DrugBankDB00935
UNII ID8VLN5B44ZY (ChemIDplus, GSRS)
Target
Agency Approved
ADRA1A
ADRA1A
ADRA2A
ADRA2A
Organism
Homo sapiens
Gene name
ADRA1A
Gene synonyms
ADRA1C
NCBI Gene ID
Protein name
alpha-1A adrenergic receptor
Protein synonyms
Alpha-1A adrenoceptor, Alpha-1A adrenoreceptor, Alpha-1C adrenergic receptor, Alpha-adrenergic receptor 1c, G protein coupled receptor
Uniprot ID
Mouse ortholog
Adra1a (11549)
alpha-1A adrenergic receptor (Q8BV77)
Alternate
HTR1D
HTR1D
HTR1B
HTR1B
ADRA2C
ADRA2C
ADRA1B
ADRA1B
HTR2C
HTR2C
ADRA1D
ADRA1D
ADRA2B
ADRA2B
Organism
Homo sapiens
Gene name
HTR1D
Gene synonyms
HTR1DA, HTRL
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 1D
Protein synonyms
5-HT-1D, 5-HT-1D-alpha, 5-hydroxytryptamine (serotonin) receptor 1D, G protein-coupled, Serotonin 1D alpha receptor, Serotonin receptor 1D
Uniprot ID
Mouse ortholog
Htr1d (15552)
5-hydroxytryptamine receptor 1D (Q8BUW7)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Rhofade – Aclaris Therapeutics
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Rhofade – Novan
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Tabular view
Estimated US medical usage
Oxymetazoline
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,606 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,967 adverse events reported
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