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)
Mechanism and Biochemical Profile
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>).