Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate loratadine for indications such as perennial allergic rhinitis, uremic pruritus in chronic kidney disease, pegfilgrastim-induced pain, and heat injury. Sponsored by academic institutions (e.g., King Edward Medical University and Thammasat University) and commercial entities (e.g., Bayer and Xian-Janssen Pharmaceutical), these studies encompass diverse recruitment statuses, including completed, recruiting, not yet recruiting, unknown, withdrawn, and terminated protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07661459 | RECRUITING | Solid Tumors |
Val Adams |
2026-06-26 | PHASE2 |
| NCT05263206 | RECRUITING | Pruritus |
Sanofi |
2022-02-15 | PHASE3 |
| NCT07300735 | RECRUITING | Hematologic Malignancy; Neutropenia; Bone Pain |
Alexandria University |
2025-03-01 | |
| NCT07532993 | NOT_YET_RECRUITING | Allergic Rhinitis (AR) |
Liaquat National Hospital & Medical College |
2026-09 | PHASE4 |
| NCT07101445 | RECRUITING | Multiple Myeloma |
Emory University |
2025-09-24 | PHASE4 |
| NCT05421416 | RECRUITING | Stem Cell Transplant Complications |
AHS Cancer Control Alberta |
2024-11-28 | PHASE2 |
| NCT04211259 | RECRUITING | Plasma Cell Myeloma |
Rutgers, The State University of New Jersey |
2022-04-18 | EARLY_PHASE1 |
| NCT07575464 | NOT_YET_RECRUITING | Auricular Acupressure; Wind-Heat Urticaria; Traditional Medicine |
University of Medicine and Pharmacy at Ho Chi Minh City |
2026-05-01 | |
| NCT06955741 | COMPLETED | Healthy Volunteer |
Bristol-Myers Squibb |
2025-05-05 | PHASE1 |
| NCT07380178 | COMPLETED | Rhinitis, Allergic, Perennial |
Universitas Sebelas Maret |
2025-04-01 | |
| NCT06250400 | UNKNOWN | Chronic Spontaneous Urticaria |
Hangzhou Grand Biologic Pharmaceutical, Inc. |
2024-03-31 | PHASE4 |
| NCT06531707 | UNKNOWN | Common Cold |
Laboratorios Silanes S.A. de C.V. |
2024-05-20 | PHASE3 |
| NCT06019728 | COMPLETED | Fabry's Disease |
Sanofi |
2023-11-10 | PHASE4 |
| NCT06265077 | COMPLETED | Breast Cancer; Filgrastim Adverse Reaction |
Noha Mansour |
2024-02-01 | PHASE1; PHASE2 |
| NCT06217367 | UNKNOWN | Heat Illness; Allergic Rhinitis; Heat Injury; Sudomotor Sympathetic Dysfunction |
Lakehead University |
2023-12-05 | PHASE4 |
| NCT05243706 | UNKNOWN | Vinca Alkaloid Adverse Reaction |
Ain Shams University |
2022-03-01 | PHASE3 |
| NCT05190627 | UNKNOWN | Lymphangioleiomyomatosis |
Institut d'Investigació Biomèdica de Bellvitge |
2021-11-01 | PHASE2 |
| NCT05750875 | COMPLETED | Pruritus; Uremia; Chronic Kidney Diseases |
King Edward Medical University |
2022-05-01 | PHASE4 |
| NCT05043350 | COMPLETED | Covid19 |
Ain Shams University |
2021-09-13 | PHASE2; PHASE3 |
| NCT05750875 | Completed | Pruritus|Uremia|Chronic Kidney Diseases |
King Edward Medical University |
2022-05-01 | Phase 4 |
| NCT05265910 | COMPLETED | Allergic Conjunctivitis |
Andover Research Eye Institute |
2021-12-14 | PHASE4 |
| NCT05243706 | Unknown status | Vinca Alkaloid Adverse Reaction |
Ain Shams University |
2022-03-01 | Phase 3 |
| NCT04248712 | TERMINATED | Eosinophilic Esophagitis |
Mayo Clinic |
2020-07-10 | PHASE2 |
| NCT02495077 | COMPLETED | Kidney Transplant |
National Institute of Allergy and Infectious Diseases (NIAID) |
2015-11-02 | PHASE2 |
| NCT04645979 | Completed | Rhinitis Allergic |
Bayer |
2020-11-11 | -- |
| NCT04162795 | COMPLETED | Allergic Rhinitis |
Bayer |
2019-11-12 | PHASE4 |
| NCT03883386 | TERMINATED | Bone Pain |
University of Michigan |
2019-06-24 | PHASE2 |
| NCT02478398 | COMPLETED | Rhinitis, Allergic, Seasonal |
Merck Sharp & Dohme LLC |
2015-07-20 | PHASE3 |
| NCT03517943 | COMPLETED | Clinical Pharmacology |
Bayer |
2018-04-24 | PHASE1 |
| NCT03517930 | COMPLETED | Clinical Pharmacology |
Bayer |
2018-04-17 | PHASE1 |
| NCT03443843 | COMPLETED | Rhinitis, Allergic |
Bayer |
2018-02-21 | PHASE4 |
| NCT02392039 | TERMINATED | Lymphoma |
M.D. Anderson Cancer Center |
2015-12-14 | EARLY_PHASE1 |
| NCT03196531 | COMPLETED | Healthy |
Xian-Janssen Pharmaceutical Ltd. |
2017-11-07 | PHASE1 |
| NCT02653339 | UNKNOWN | Rhinitis, Allergic, Perennial |
Peking Union Medical College Hospital |
2016-06 | |
| NCT03376594 | COMPLETED | Allergic Rhinitis |
Thammasat University |
2017-07-30 | PHASE2 |
| NCT03640273 | COMPLETED | Allergic Rhinitis; Adverse Drug Event; Quality of Life |
Thammasat University |
2017-11-23 | PHASE2 |
| NCT02576808 | COMPLETED | Rhinitis,Allergic |
Thai Traditional Medical Knowledge Fund |
2015-10 | PHASE2 |
| NCT03151720 | COMPLETED | Healthy |
Xian-Janssen Pharmaceutical Ltd. |
2017-06-01 | PHASE1 |
| NCT03004131 | COMPLETED | Seasonal Allergic Rhinitis |
MEDA Pharma GmbH & Co. KG |
2017-01-07 | PHASE4 |
| NCT02339714 | COMPLETED | Rhinitis, Allergic, Perennial |
Zhao Hong |
2015-03 | PHASE2 |
| NCT02583594 | COMPLETED | Progressive Multiple Sclerosis |
Genzyme, a Sanofi Company |
2015-12-06 | PHASE1 |
| NCT03372473 | COMPLETED | Asthma in Children |
Innovacion y Desarrollo de Estrategias en Salud |
2016-01-10 | PHASE3 |
| NCT02593747 | COMPLETED | Histamine H1 Antagonists, Non-Sedating |
Bayer |
2015-12 | PHASE1 |
| NCT01700192 | COMPLETED | Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal |
ALK-Abelló A/S |
2013-01 | PHASE3 |
| NCT01712009 | COMPLETED | Bone Pain in Stage I - III Breast Cancer |
Amgen |
2012-11-01 | PHASE2 |
| NCT02513290 | COMPLETED | Allergic Rhinitis |
Universidade do Sul de Santa Catarina |
2013-08 | PHASE4 |
| NCT02007434 | COMPLETED | Moderate or Severe Submental Fullness |
Kythera Biopharmaceuticals |
2013-12 | PHASE3 |
| NCT01390441 | TERMINATED | Rheumatoid Arthritis |
Merck Sharp & Dohme LLC |
2011-07 | PHASE1 |
| NCT01311336 | UNKNOWN | Pegfilgrastim-induced Back and Leg Pain |
University of Vermont |
2011-05 | PHASE2 |
| NCT01673620 | COMPLETED | Allergic Rhinitis |
Organon and Co |
2012-07-04 | PHASE3 |
| NCT01228630 | COMPLETED | Perennial Allergic Rhinitis |
Azidus Brasil |
2011-08 | PHASE3 |
| NCT01469234 | COMPLETED | Rhinitis |
Bayer |
2011-10 | PHASE4 |
| NCT01413958 | COMPLETED | Seasonal Allergic Rhinitis |
Bayer |
2011-08 | PHASE3 |
| NCT01330017 | COMPLETED | Rhinitis; Seasonal Rhinitis |
Bayer |
2011-03 | PHASE2 |
| NCT01055756 | WITHDRAWN | Allergic Rhinitis |
Azidus Brasil |
2010-01 | PHASE3 |
| NCT00550550 | COMPLETED | Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy |
ALK-Abelló A/S |
2007-11 | PHASE3 |
| NCT00562159 | COMPLETED | Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy |
ALK-Abelló A/S |
2007-11 | PHASE3 |
| NCT00481676 | COMPLETED | Chronic Urticaria |
Novartis |
2007-05 | PHASE2 |
| NCT00730912 | COMPLETED | Perennial Allergic Rhinitis |
Merck Sharp & Dohme LLC |
2008-06 | PHASE4 |
| NCT00721331 | COMPLETED | Atopic Dermatitis |
Zalicus |
2008-07 | PHASE1 |
| NCT00561717 | COMPLETED | Seasonal Allergic Rhinitis |
Bayer |
2007-10 | PHASE4 |
| NCT00423995 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2006-11-01 | PHASE3 |
| NCT00963573 | COMPLETED | Rhinitis |
Merck Sharp & Dohme LLC |
2003-09 | PHASE4 |
| NCT00776282 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2006-07 | |
| NCT00776217 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2006-06 | |
| NCT00319995 | COMPLETED | Rhinitis, Allergic, Seasonal |
Organon and Co |
2006-03-01 | PHASE3 |
| NCT00946608 | COMPLETED | Allergy |
Sandoz |
2005-06 | PHASE1 |
| NCT00525382 | COMPLETED | Urticaria |
UCB Pharma |
2003-08 | PHASE3 |
| NCT00524836 | COMPLETED | Rhinitis; Allergic; Perennial |
UCB Pharma |
2003-09 | PHASE3 |
| NCT00525278 | COMPLETED | Rhinitis; Allergic; Seasonal |
UCB Pharma |
2003-08 | PHASE3 |
| NCT00837915 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2002-06 | |
| NCT00845546 | COMPLETED | Healthy |
Ranbaxy Laboratories Limited |
2002-06 | |
| NCT00963469 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2001-08 | PHASE3 |
| NCT02932774 | COMPLETED | Allergic Rhinitis; Hay Fever; SAR; Rhinitis, Allergic, Seasonal |
Johnson & Johnson Consumer and Personal Products Worldwide |
2001-03 | PHASE4 |
| NCT00972738 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2001-04 | PHASE3 |
| NCT00960141 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2000-08 | PHASE3 |
| NCT00979901 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
2000-03 | PHASE3 |
| NCT00963599 | COMPLETED | Seasonal Allergic Rhinitis |
Organon and Co |
1999-09 | PHASE3 |
| NCT03855228 | COMPLETED | Rhinitis, Allergic |
Organon and Co |
1995-03-01 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-08-14)
Check the
Loratadine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.