Desloratadine

Overview

Desloratadine is a second generation, tricyclic antihistamine that which has a selective and peripheral H1-antagonist action. It is the active descarboethoxy metabolite of loratidine (a second generation histamine). Desloratidine has a long-lasting effect and does not cause drowsiness because it does not readily enter the central nervous system.

Indication

For the relief of symptoms of seasonal allergic rhinitis, perennial (non-seasonal) allergic rhinitis. Desloratidine is also used for the sympomatic treatment of pruritus and urticaria (hives) associated with chronic idiopathic urticaria.

Associated Conditions

Allergic Rhinitis (AR)
Asthma
Chronic Idiopathic Urticaria
Common Cold
Nasal Congestion
Perennial Allergic Rhinitis (PAR)
Seasonal Allergic Rhinitis
Nasal symptoms
Non-nasal symptoms

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine	2025/04/08	NCT06916884	Phase 3	Recruiting	Laboratorios Silanes S.A. de C.V.
Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.	2024/02/22	NCT06272409	Phase 3	Not yet recruiting	EMS
Antiplatelet Therapy in Chronic Urticaria	2024/02/20	NCT06268470	Phase 2	Active, not recruiting	Chulalongkorn University
Over-the-Counter Antihistamines & Heat Stress	2024/01/22	NCT06217367	Phase 4	Recruiting	Lakehead University
Role of Desloratadine in Reducing Inflammation From Occupational Heat Strain	2022/07/06	NCT05446480	Not Applicable	UNKNOWN	University of Victoria
A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis	2022/02/10	NCT05232825	Phase 3	Active, not recruiting	Hoffmann-La Roche
Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children	2022/01/31	NCT05214911	Phase 3	Completed	Eurofarma Laboratorios S.A.
Influence of Antipruritics on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.	2020/05/22	NCT04399148	Not Applicable	Completed	Universitaire Ziekenhuizen KU Leuven
Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin.	2020/05/22	NCT04399525	Not Applicable	Completed	Universitaire Ziekenhuizen KU Leuven
Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment	2016/01/05	NCT02646020	Phase 2	Completed	Sun Yat-sen University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Clarinex	Organon LLC	78206-188	ORAL	5 mg in 1 1	8/23/2022
DESLORATADINE	Bryant Ranch Prepack	71335-1000	ORAL	5 mg in 1 1	4/19/2019
CLARINEX-D 12 HOUR	Organon LLC	78206-120	ORAL	2.5 mg in 1 1	6/1/2021
DESLORATADINE	Lupin Pharmaceuticals, Inc.	68180-153	ORAL	5 mg in 1 1	1/19/2024
Clarinex	A-S Medication Solutions	50090-0765	ORAL	5 mg in 1 1	1/27/2021
Desloratadine	Virtus Pharmaceuticals	69543-107	ORAL	5 mg in 1 1	8/27/2020
Desloratadine	Sun Pharmaceutical Industries, Inc.	62756-523	ORAL	5 mg in 1 1	5/8/2019
Desloratadine	Belcher Pharmaceuticals,LLC	62250-619	ORAL	5 mg in 1 1	10/5/2023
Clarinex	Rebel Distributors Corp	21695-815	ORAL	5 mg in 1 1	10/30/2008
Clarinex	Organon LLC	78206-119	ORAL	5 mg in 1 1	8/23/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Aerinaze	N.V. Organon,Kloosterstraat 6,5349 AB, Oss,Netherlands	Authorised	7/30/2007
Neoclarityn	N.V. Organon,Kloosterstraat 6,5349 AB Oss,The Netherlands	Authorised	1/15/2001
Desloratadine Actavis	Actavis Group PTC ehf,Dalshraun 1,220 Hafnarfjörður,Iceland	Authorised	1/13/2012
Aerius	N.V. Organon,Kloosterstraat 6,5349 AB, Oss,Netherlands	Authorised	1/15/2001
Desloratadine Teva	Teva B.V,Swensweg 5,2031GA Haarlem,The Netherlands	Authorised	11/24/2011
Desloratadine ratiopharm	Ratiopharm GmbH,Graf-Arco-Str. 3,D-89079 Ulm,Germany	Authorised	1/13/2012
Dasselta	Krka, d.d., Novo mesto,Šmarješka cesta 6,8501 Novo mesto,Slovenia	Authorised	11/28/2011
Azomyr	N.V. Organon,Kloosterstraat 6,5349 AB Oss,The Netherlands	Authorised	1/15/2001

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Aerius D-12 Modified Release Tablets 2.5mg/120mg	Patheon Inc., Whitby Operations	SIN13772P	TABLET, DELAYED RELEASE	2.5mg	3/5/2010
AERIUS ORAL SOLUTION 0.5 mg/ml	Organon Heist bv	SIN12530P	SOLUTION	0.5 mg/mL	4/5/2004
AERIUS TABLET 5 mg	Organon Heist bv	SIN11743P	TABLET, FILM COATED	5 mg	12/26/2001
DESTAVELL FILM-COATED TABLET 5 MG	PT. Novell Pharmaceutical Laboratories	SIN16298P	TABLET, FILM COATED	5 mg	8/13/2021
DESLORATADINE SANDOZ FILM COATED TABLET 5MG	Sandoz Private Limited	SIN15773P	TABLET, FILM COATED	5mg	8/7/2019
DESTACURE SYRUP 2.5 MG/5ML	Gracure Pharmaceuticals Limited	SIN16186P	SYRUP	2.500 mg/5ml	5/10/2021
AIRISTAR FILM-COATED TABLET 5MG	GENEPHARM SA	SIN15938P	TABLET, FILM COATED	5mg	5/11/2020
GLENDES TABLET 5 mg	Glenmark Pharmaceuticals Limited	SIN16670P	TABLET	5 mg	1/5/2023
ALRINAST FILM-COATED TABLET 5MG	İlko İlaç Sanayi ve Ticaret A. Ş.	SIN16170P	TABLET, FILM COATED	5.00mg	4/27/2021

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Desloratadine Capsules	广东九明制药有限公司	国药准字H20138004	化学药品	胶囊剂	5/23/2023
Desloratadine for Suspension	海南普利制药股份有限公司	国药准字H20041111	化学药品	口服混悬剂	9/15/2020
Desloratadine for Suspension	海南普利制药股份有限公司	国药准字H20110018	化学药品	口服混悬剂	9/15/2020
Desloratadine Syrup	成都天之翼尚品医药科技有限公司	国药准字H20183056	化学药品	糖浆剂	3/1/2023
Desloratadine Syrup	国药集团致君（深圳）坪山制药有限公司	国药准字H20213882	化学药品	糖浆剂	11/24/2021
Desloratadine Syrup	江苏广承药业有限公司	国药准字H20183211	化学药品	糖浆剂	4/17/2023
Desloratadine Syrup	湖北康源药业有限公司	国药准字H20183268	化学药品	糖浆剂	3/13/2023
Desloratadine Syrup	万特制药（海南）有限公司	国药准字H20100009	化学药品	糖浆剂	10/23/2019
Desloratadine Tablets	合肥国药诺和药业有限公司	国药准字H20243626	化学药品	片剂	4/30/2024
Desloratadine Tablets	广东怡至药品研究院有限公司	国药准字H20243706	化学药品	片剂	5/15/2024

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
DESLORATADINE GENEPHARM TABLETS 5MG	N/A	SB PHARMA LIMITED	N/A	N/A	9/11/2024
AERIUS D-12 MODIFIED RELEASE TAB	N/A	BAYER HEALTHCARE LIMITED	N/A	N/A	10/30/2009

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DESONEX desloratadine 5 mg tablet film coated blister pack	352515	Bayer Australia Ltd	Medicine	A	1/5/2021
HAYZEP desloratadine 5mg tablets blister pack	172630	Alphapharm Pty Ltd	Medicine	A	6/29/2010
AERIUS FOR CHILDREN SYRUP desloratadine 2.5mg/5mL oral liquid bottle	97260	Bayer Australia Ltd	Medicine	A	9/25/2003
DESDINE FOR CHILDREN desloratadine 2.5mg/5mL oral liquid bottle	233074	Aspen Pharmacare Australia Pty Ltd	Medicine	A	1/21/2015
PHARMACY ACTION 24 HOUR DESLORATADINE ALLERGY RELIEF desloratadine 5mg tablet blister pack	355610	Lupin Australia Pty Limited	Medicine	A	2/25/2021
ADIRAMEDICA DESLORATADINE SYRUP desloratadine 2.5mg/5mL syrup bottle	315084	AdiraMedica Pty Ltd	Medicine	A	3/5/2019
APO-DESLORATADINE 5mg tablets blister pack	202823	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/9/2012
APOHEALTH DESLORATADINE desloratadine 5 mg tablet blister pack (new formulation)	385719	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/16/2022
APO-DESLORATADINE 5mg tablets bottles	202822	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/9/2012
CHEMISTS' OWN DESLORATADINE HAYFEVER & ALLERGY RELIEF desloratadine 5 mg tablet blister pack	327149	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/5/2019

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