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 49m ago · AI intelligence enriched 3h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLARINEX (desloratadine) is an oral H1-receptor histamine antagonist approved for allergic rhinitis and urticaria. It works by blocking histamine at the H1 receptor with minimal blood-brain barrier penetration, reducing allergic symptoms without significant sedation. The syrup formulation enables dosing flexibility across age groups.
$0.3MPart D
LOE ApproachingProduct nearing LOE with minimal Part D claims indicates a mature, stable market with contracted team footprint and limited growth investment.
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 Extended-release Tablets Under Fed Conditions
Started Apr 2006
44 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.