Clinical Trials

Numerous clinical trials evaluate the therapeutic profile of desloratadine across diverse indications, focusing primarily on allergic conditions—such as seasonal and perennial allergic rhinitis, chronic urticaria, rhinorrhea, and post-nasal drip—alongside exploratory studies in heat illness, rheumatoid arthritis, and ulcerative colitis. Spanning Phase 1 through Phase 4 trials as well as post-marketing surveillance, these studies are sponsored by academic institutions and pharmaceutical entities, with recruitment statuses ranging from planned and active to completed or suspended.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07109817 RECRUITING
Breast Cancer; Peripheral Neuropathy
Montefiore Medical Center
2026-09 PHASE2
NCT07566351 RECRUITING
Rheumatoid Arthritis
Horus University
2026-04-23 PHASE2
NCT07333716 RECRUITING
Ulcerative Colitis (UC); Ulcerative Colitis
Tanta University
2026-01-26 PHASE2
NCT07632872 RECRUITING
Rheumatoid Arthritis (RA); Rheumatoid Arthritis
Horus University
2026-05-23 PHASE2
NCT07486583 NOT_YET_RECRUITING
Chronic Idiopathic Urticaria
Cairo University
2026-04-30 PHASE3
NCT06916884 COMPLETED
Allergic Rhinitis
Laboratorios Silanes S.A. de C.V.
2024-11-11 PHASE3
NCT05214911 COMPLETED
Allergic Rhinitis
Eurofarma Laboratorios S.A.
2024-07-08 PHASE3
NCT06272409 NOT_YET_RECRUITING
Allergic Rhinitis
EMS
2025-02-15 PHASE3
NCT06272409 Not yet recruiting
Allergic Rhinitis
EMS
2025-02-15 Phase 3
NCT06217367 UNKNOWN
Heat Illness; Allergic Rhinitis; Heat Injury; Sudomotor Sympathetic Dysfunction
Lakehead University
2023-12-05 PHASE4
NCT06268470 UNKNOWN
Chronic Urticaria
Chulalongkorn University
2018-06-01 PHASE2
NCT05446480 UNKNOWN
Heat Stress, Exertional; Inflammatory Response; Firefighter Personal Protective Equipment
University of Victoria
2022-07
NCT05232825 COMPLETED
Relapsing Multiple Sclerosis; Primary Progressive Multiple Sclerosis
Hoffmann-La Roche
2022-05-03 PHASE3
NCT02904304 SUSPENDED
Cold
Ache Laboratorios Farmaceuticos S.A.
2020-12 PHASE3
NCT02904304 Suspended
Cold
Ache Laboratorios Farmaceuticos S.A.
2020-12 Phase 3
NCT02646020 COMPLETED
Non-small Cell Lung Cancer
Sun Yat-sen University
2015-12 PHASE2
NCT04399525 COMPLETED
Pruritus
Universitaire Ziekenhuizen KU Leuven
2019-10-28
NCT04399148 COMPLETED
Pruritus
Universitaire Ziekenhuizen KU Leuven
2019-06-11
NCT01529242 TERMINATED
Cutaneous Hypersensitivity
EMS
2014-02 PHASE3
NCT02320396 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
2015-01-09 PHASE3
NCT01529229 COMPLETED
Allergic Rhinitis
EMS
2013-11 PHASE3
NCT00967967 SUSPENDED
Asthma; Rhinitis
Laval University
2009-03
NCT01985789 COMPLETED
Asthma
Don Cockcroft
2013-11 PHASE4
NCT01916980 COMPLETED
Eczema; Dermatitis; Dermal Pruritus
Organon and Co
2013-08-27 PHASE3
NCT01916967 COMPLETED
Urticaria
Organon and Co
2013-08-27 PHASE3
NCT01918033 COMPLETED
Perennial Allergic Rhinitis
Organon and Co
2013-08-20 PHASE3
NCT01940393 COMPLETED
Urticaria
Grupo de Alergología Clínica y Experimental
2013-08 PHASE4
NCT01720485 UNKNOWN
Allergic Rhinitis
EMS
2013-10 PHASE3
NCT01400828 COMPLETED
Seasonal Allergic Rhinitis
Yuhan Corporation
2011-06 PHASE3
NCT02507635 COMPLETED
Allergic Rhinitis
Iuliu Hatieganu University of Medicine and Pharmacy
2009-02 PHASE4
NCT01444196 COMPLETED
Urticaria
Marcus Maurer
2009-08 PHASE4
NCT00598611 COMPLETED
Chronic Urticaria
Charite University, Berlin, Germany
2007-09 PHASE3
NCT00536380 COMPLETED
Chronic Idiopathic Urticaria
Organon and Co
2007-09 PHASE4
NCT00633919 COMPLETED
Allergy
ALK-Abelló A/S
2006-07 PHASE2; PHASE3
NCT00405964 COMPLETED
Allergic Rhinitis
Organon and Co
2006-09 PHASE3
NCT00862225 COMPLETED
Seasonal Allergic Rhinitis
Max Zeller Soehne AG
2008-01 PHASE2
NCT00761527 Completed
Rhinitis Allergic Seasonal|Rhinitis Allergic Perennial|Urticaria
Organon and Co
2008-03 --
NCT00406783 COMPLETED
Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
Organon and Co
2006-08 PHASE3
NCT00600847 COMPLETED
Acquired Cold Urticaria
Charite University, Berlin, Germany
2006-11 PHASE4
NCT00424580 COMPLETED
Asthma
University of Saskatchewan
2007-01
NCT00264303 COMPLETED
Chronic Idiopathic Urticaria
UCB Pharma
2005-12 PHASE4
NCT00359138 COMPLETED
Hypersensitivity
Organon and Co
2006-02 PHASE4
NCT01314352 COMPLETED
Fed
Dr. Reddy's Laboratories Limited
2005-12 PHASE1
NCT01314339 COMPLETED
Fasting
Dr. Reddy's Laboratories Limited
2005-12 PHASE1
NCT00779116 COMPLETED
Allergies
Organon and Co
2005-09 PHASE4
NCT00780403 COMPLETED
Allergies
Organon and Co
2005-08 PHASE4
NCT00160589 COMPLETED
Rhinitis, Allergic, Perennial
UCB Pharma
2005-04 PHASE4
NCT00160537 COMPLETED
Seasonal Allergic Rhinitis
UCB Pharma
2005-05 PHASE4
NCT00816972 COMPLETED
Post-nasal Drip; Seasonal Allergic Rhinitis; Rhinorrhea
Organon and Co
2005-04 PHASE2
NCT00311844 COMPLETED
Conjunctivitis, Allergic
Organon and Co
2005-03-01 PHASE4
NCT00751218 COMPLETED
Urticaria
Organon and Co
2004-05-06 PHASE4
NCT00751166 TERMINATED
Urticaria
Organon and Co
2004-03-01 PHASE4
NCT00795522 COMPLETED
Urticaria
Organon and Co
2003-07 PHASE4
NCT00521170 COMPLETED
Allergy
UCB Pharma
2004-11 PHASE1
NCT00779636 COMPLETED
Allergic Airway Disease
Organon and Co
2003-07-01 PHASE4
NCT00794378 COMPLETED
Allergic Rhinitis
Organon and Co
2004-11 PHASE3
NCT00794794 COMPLETED
Allergic Rhinitis
Organon and Co
2004-11 PHASE3
NCT00783146 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
2004-08-01 PHASE4
NCT00783211 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
2004-08-01 PHASE4
NCT00789152 COMPLETED
Allergic Rhinitis
Organon and Co
2003-12-01 PHASE3
NCT00783354 COMPLETED
Urticaria; Chronic Idiopathic Urticaria
Organon and Co
2003-04-01 PHASE4
NCT00795158 COMPLETED
Urticaria
Organon and Co
2002-11 PHASE3
NCT00757562 COMPLETED
Chronic Idiopathic Urticaria; Atopy
Organon and Co
2002-11-01 PHASE3
NCT01108783 COMPLETED
Seasonal Allergic Rhinitis
Faes Farma, S.A.
2003-04 PHASE3
NCT00794599 COMPLETED
Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis
Organon and Co
2002-12 PHASE4
NCT00805324 COMPLETED
Rhinitis, Allergic, Seasonal; Asthma
Organon and Co
2003-05 PHASE3
NCT00794768 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
2002-11 PHASE4
NCT00817076 COMPLETED
Dermatitis, Atopic
Organon and Co
2003-03 PHASE3
NCT00794495 COMPLETED
Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis
Organon and Co
2002-12 PHASE4
NCT00783133 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
2002-11-01 PHASE4
NCT00805584 COMPLETED
Rhinitis, Allergic, Seasonal
Organon and Co
2003-05 PHASE4
NCT00794846 COMPLETED
Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis
Organon and Co
2002-12 PHASE4
NCT00794248 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
2002-11 PHASE4
NCT00867191 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
2002-02-01 PHASE4
NCT01506050 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2006-01 PHASE1
NCT01506037 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2006-01 PHASE1
NCT01373138 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2006-04 PHASE1
NCT01506791 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
2006-04 PHASE1
NCT00636870 COMPLETED
Allergic Rhinitis
Sanofi
2003-02 PHASE4
NCT00637585 COMPLETED
Allergic Rhinitis
Sanofi
2002-12 PHASE4
NCT00346606 UNKNOWN
Chronic Idiopathic Urticaria; Urticaria
Lotus Pharmaceutical
2006-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Desloratadine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Desloratadine functions as a potent antagonist of the human histamine H1 receptor (IC50 = 51 nM), selectively binding to the receptor to prevent histamine-induced activation of downstream signaling pathways and subsequent proinflammatory mediator release from mast cells and basophils. By suppressing endothelial permeability, mucosal edema, and smooth muscle constriction, this targeted inhibition alleviates allergic symptoms such as rhinorrhea, nasal congestion, and pruritus in clinical conditions including allergic rhinitis and urticaria.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.