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Data updated: Jul 17, 2026

CLARINEX (desloratadine) · Merck

Respiratory Approved 2001-12-21
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
1
Priority Reviews
24
Years on Market

Details

Status
Prescription
First Approved
2001-12-21
Routes
Oral, ORAL
Dosage Forms
Tablet, SYRUP, SOLUTION, TABLET, ORALLY DISINTEGRATING, TABLET

Companies

Merck
Active Ingredient: DESLORATADINE

CLARINEX Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
53 FDA actions from 2001 to 2019
Mar 2019 SUPPL
Label · Labeling
FDA Letter Label
Mar 2019 SUPPL
Label · Labeling
FDA Letter Label
Jun 2016 SUPPL
Mfg · Manufacturing (CMC)

What CLARINEX Treats

4 FDA approvals

Originally approved for its first indication in 2001 . Covers 4 distinct patient populations.

  • Other (4)
📋

Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT07566351 MDP.26.03.216 Ph 2 recruiting Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis
NCT07486583 MD-142-2025 Ph 3 not yet recruiting Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.
NCT07333716 UC 12/2025 TRop1 Ph 2 recruiting Desloratadine in Patients With Ulcerative Colitis
NCT05214911 DESPRED EF177 Ph 3 completed Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children
NCT06916884 DESCUBRA SIL-30810-III-23(1) Ph 3 recruiting Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
NCT01916967 results posted 4117-201 132243 Ph 3 completed An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
NCT02646020 EGFR-TKIs TAPE001 Ph 2 completed Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment
NCT02507635 535 Ph 4 completed Anti-inflammatory H1 Antihistamines Allergic Rhinitis
NCT01985789 PHPY2013/14 Ph 4 completed Anti-histamines and Methacholine Challenges.
NCT01400828 YCD159 Ph 3 completed Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
NCT01940393 GACE-01 Ph 4 completed Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria
NCT01444196 AECUDATT 2008-005746-22 2008-005746-22 Ph 4 completed Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CLARINEX FDA Label Details

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Data Sources

FDA Approval: NDA021297 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.