NDAORALSYRUPPriority Review
Approved
Sep 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
4/8 — Partial
Priority Review
CLARINEX (desloratadine) by Merck & Co. is 1 -receptor histamine antagonist activity. First approved in 2004.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLARINEX (desloratadine) is an oral H1-receptor histamine antagonist approved for allergic rhinitis symptom relief. It works by blocking histamine release from mast cells and does not significantly cross the blood-brain barrier, minimizing central nervous system effects. The syrup formulation is available for pediatric and adult populations.
$0.289MPart D
LOE ApproachingMature product entering LOE phase with minimal Part D volume; commercial team likely focused on retention and cost management rather than growth initiatives.
Mechanism of Action
1 -receptor histamine antagonist activity. Receptor binding data indicate that at a concentration of 2 to 3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H 1 receptor. Desloratadine inhibited histamine release from human mast cells in vitro . Results of a…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
Started Dec 2020
150 enrolled
Cold
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment
Started Feb 2014
17 enrolled
Cutaneous Hypersensitivity
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment
Started Nov 2013
210 enrolled
Allergic Rhinitis
Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment
Started Oct 2013
234 enrolled
Allergic Rhinitis
Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions
Started Apr 2006
34 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.