Data updated: May 26, 2026
DESLORATADINE
Respiratory
Approved 2010-02-19
11
Indications
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2010-02-19
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, TABLET, ORALLY DISINTEGRATING
Companies
Sun Pharma TARO ZYDUS PHARMS USA ORBION PHARMS CHARTWELL RX Lupin PERRIGO Dr. Reddy's AJENAT PHARMS REDDYS NATCO PHARMA USA GLENMARK GENERICS
Active Ingredient: DESLORATADINE
Website: ↗
DESLORATADINE Approval History
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 2010 to 2023
May 2023 SUPPL
Label · Labeling
Oct 2019 SUPPL
Label · Labeling
Oct 2019 SUPPL
Label · Labeling
Oct 2019 SUPPL
Label
Oct 2017 SUPPL
Label
May 2016 ORIGINAL
Update
Jun 2015 ORIGINAL
Update
Feb 2015 SUPPL
Label
Feb 2015 SUPPL
Label
May 2014 SUPPL
Mfg
Jan 2014 SUPPL
Label
Dec 2013 SUPPL
Label
Oct 2013 SUPPL
Label
Apr 2012 ORIGINAL
Update
Feb 2012 ORIGINAL
Update
Dec 2011 ORIGINAL
Update
Nov 2011 SUPPL
Label
Nov 2011 SUPPL
Label
Mar 2011 ORIGINAL
Update
Dec 2010 ORIGINAL
Update
Nov 2010 ORIGINAL
Update
Oct 2010 ORIGINAL
Update
What DESLORATADINE Treats
11 FDA approvalsOriginally approved for its first indication in 2010 . Covers 11 distinct patient populations.
- Other (11)
Other
(11 approvals)- • Approved indication (Feb 2010)Letter
- • Approved indication (Jul 2010)Letter
- • Approved indication (Oct 2010)
- • Approved indication (Nov 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Mar 2011)
- • Approved indication (Dec 2011)
- • Approved indication (Feb 2012)
- • Approved indication (Apr 2012)
- • Approved indication (Jun 2015)
- • Approved indication (May 2016)
📋
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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
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.
DESLORATADINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.