CLARINEX-D 12 HOUR (desloratadine)
Clarinex-D 12 Hour is a combination medication used for adults and adolescents 12 years of age and older who suffer from seasonal allergic rhinitis. It helps patients with both nasal and non-nasal allergy symptoms, including persistent nasal congestion. This extended-release tablet is used when a patient requires the dual action of an antihistamine and a nasal decongestant.
How CLARINEX-D 12 HOUR Works
This medication works by targeting two different pathways. Desloratadine blocks H1 histamine receptors and inhibits the release of histamine from mast cells, while pseudoephedrine acts on the nasal mucosa as a sympathomimetic amine to reduce congestion.
Details
- Status
- Prescription
- First Approved
- 2006-02-01
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
CLARINEX-D 12 HOUR Approval History
What CLARINEX-D 12 HOUR Treats
2 indicationsCLARINEX-D 12 HOUR is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Seasonal Allergic Rhinitis
- Nasal Congestion
CLARINEX-D 12 HOUR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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-D 12 HOUR FDA Label Details
Indications & Usage
FDA Label (PDF)CLARINEX-D 12 HOUR is indicated for the treatment of Seasonal Allergic Rhinitis; Nasal Congestion.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.