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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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Rhofade, Upneeq, Visine (discontinued: Ocuclear, Oxymetazoline)
CombinationsKovanaze
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 & Johnson | N-019407 OTC | 1989-03-31 | 1 products, RLD, RS |
| RHOFADE | Mayne Group | N-208552 RX | 2017-01-18 | 1 products, RLD, RS |
| UPNEEQ | RVL Pharmaceuticals | N-212520 RX | 2020-07-08 | 1 products, RLD, RS |
Show 1 discontinued
Oxymetazoline hydrochloride
+
Tetracaine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| KOVANAZE | St Renatus | N-208032 RX | 2016-06-29 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 7 select original nasal | OTC monograph final | 2019-11-14 |
| afrin | C200263 | 2024-12-06 |
| afrin allergy sinus nasal | C200263 | 2024-12-06 |
| afrin no drip | C200263 | 2024-12-06 |
| afrin no drip night | C200263 | 2024-12-06 |
| afrin no-drip | C200263 | 2024-12-06 |
| afrin nodrip allergy sinus night | C200263 | 2024-12-06 |
| afrin original | C200263 | 2024-12-18 |
| afrin original nasal | C200263 | 2023-11-05 |
| anefrin nasal | C200263 | 2024-09-07 |
Show 131 more
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OXYMETAZOLINE HYDROCHLORIDE, UPNEEQ, RVL PHARMS | |||
| 2023-07-08 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Oxymetazoline Hydrochloride, Upneeq, Rvl Pharms | |||
| 10799481 | 2039-12-16 | U-2849 | |
| 10814001 | 2039-12-16 | DP | |
| 10898573 | 2039-12-16 | DP | |
| 10940138 | 2039-12-16 | U-2849 | |
| 11103482 | 2039-12-16 | DP | |
| 11311515 | 2039-12-16 | DP | |
| 11324722 | 2039-12-16 | U-2849 | |
| 11541036 | 2039-12-16 | DP | |
| 8357714 | 2031-08-26 | U-2849 | |
| 9867808 | 2031-08-26 | U-2849 | |
| 10912765 | 2031-08-26 | U-2849 | |
| Oxymetazoline Hydrochloride, Rhofade, Mayne Pharma | |||
| 9974773 | 2035-06-11 | U-2306 | |
| 10335391 | 2035-06-11 | U-2567 | |
| 10751325 | 2035-06-11 | U-2921 | |
| 11517560 | 2035-06-11 | U-3494 | |
| 8883838 | 2031-12-01 | DP | |
| 7812049 | 2028-05-02 | U-1959 | |
| 8420688 | 2024-08-02 | U-1959 | |
| 8815929 | 2024-01-22 | U-1959 | |
| Oxymetazoline Hydrochloride / Tetracaine Hydrochloride, Kovanaze, St Renatus | |||
| 8580282 | 2030-04-02 | DP | U-1876 |
| 9308191 | 2030-04-02 | DP | U-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
766 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis | D065631 | — | J30.9 | — | 1 | 3 | 1 | — | 5 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | 1 | 3 | 1 | — | 5 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 2 | 1 | — | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vasomotor rhinitis | D012223 | EFO_0007533 | J30.0 | — | — | 1 | — | — | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | 1 | — | — | 1 |
| Human experimentation | D006805 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 2 | — | — | — | — | 2 |
| Pharmacokinetics | D010599 | — | — | 2 | — | — | — | — | 2 |
| Biological availability | D001682 | — | — | 2 | — | — | — | — | 2 |
| Essential hypertension | D000075222 | — | I10 | 1 | — | — | — | — | 1 |
| Chagas disease | D014355 | EFO_0008559 | B57 | 1 | — | — | — | — | 1 |
| Nasal obstruction | D015508 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Oxymetazoline |
| INN | oxymetazoline |
| 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 class | antihistamines/local vasoconstrictors (antazoline type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1 |
Identifiers
| PDB | — |
| CAS-ID | 1491-59-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL762 |
| ChEBI ID | 7862 |
| PubChem CID | 4636 |
| DrugBank | DB00935 |
| UNII ID | 8VLN5B44ZY (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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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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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,817 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,461 adverse events reported
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