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Drug ReportsDesloratadine
Clarinex, Azomyr(desloratadine)
Aerinaze, Aerius, Azomyr, Clarinex, Dasselta, Desloratadine, Neoclarityn (desloratadine) is a small molecule pharmaceutical. Desloratadine was first approved as Azomyr on 2001-01-15. It is used to treat allergic rhinitis perennial, allergic rhinitis seasonal, and urticaria in the USA. It has been approved in Europe to treat allergic rhinitis perennial, allergic rhinitis seasonal, and urticaria. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Clarinex (generic drugs available since 2010-02-19)
Combinations
Clarinex (generic drugs available since 2010-02-19, discontinued: Clarinex d)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Desloratadine
Tradename
Company
Number
Date
Products
CLARINEXOrganonN-021165 RX2001-12-21
1 products, RLD, RS
Show 2 discontinued
Desloratadine
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
CLARINEX-D 12 HOUROrganonN-021313 RX2006-02-01
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
clarinexNew Drug Application2022-11-14
clarinex-d 12 hourNew Drug Application2022-06-01
desloratadineANDA2024-01-19
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AX: Other antihistamines for systemic use in atc
— R06AX27: Desloratadine
HCPCS
No data
Clinical
Clinical Trials
82 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 seasonalD006255EFO_0003956J30—2511119
Allergic rhinitisD065631—J30.9——84—12
UrticariaD014581EFO_0005531L50——27312
Chronic urticariaD000080223—L50.8—224—8
Allergic rhinitis perennialD012221EFO_1001417J30.89——2417
HypersensitivityD006967HP_0012393T78.40111316
AsthmaD001249EFO_0000270J45——1124
Allergic conjunctivitisD003233EFO_0007141H10.44——11—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cold temperatureD003080————1——1
EczemaD004485HP_0000964L30.9——1——1
DermatitisD003872HP_0011123L30.9——1——1
Atopic dermatitisD003876EFO_0000274L20——1——1
Relapsing-remitting multiple sclerosisD020529EFO_0003929———1——1
Chronic progressive multiple sclerosisD020528EFO_0003840———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289———1———1
RhinorrheaD000086722———1———1
Peanut hypersensitivityD021183EFO_0007425——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
FastingD005215EFO_0002756—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RhinitisD012220EFO_0008521J31————44
PruritusD011537HP_0000989L29————22
InflammationD007249MP_0001845—————11
Heat stress disordersD018882—T67.2————11
StrokeD020521EFO_0000712I63.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDesloratadine
INNdesloratadine
Description
Desloratadine is loratadine in which the ethoxycarbonyl group attached to the piperidine ring is replaced by hydrogen. The major metabolite of loratidine, desloratadine is an antihistamine which is used for the symptomatic relief of allergic conditions including rhinitis and chronic urticaria. It does not readily enter the central nervous system, so does not cause drowsiness. It has a role as a H1-receptor antagonist, an anti-allergic agent, a cholinergic antagonist and a drug metabolite.
Classification
Small molecule
Drug classtricyclic histaminic-H1 receptor antagonists, loratadine derivatives (formerly-tadine)
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Structure (InChI/SMILES or Protein Sequence)
Clc1ccc2c(c1)CCc1cccnc1C2=C1CCNCC1
Identifiers
PDB—
CAS-ID100643-71-8
RxCUI—
ChEMBL IDCHEMBL1172
ChEBI ID291342
PubChem CID124087
DrugBankDB00967
UNII IDFVF865388R (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Clarinex – Organon
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Estimated US medical usage
Desloratadine
Total medical expenditures per year (USD, in millions)
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Desloratadine
+
Pseudoephedrine
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 2,200 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,099 adverse events reported
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