Clinical Trials

Fexofenadine HCl has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, focusing on seasonal allergic rhinitis, chronic urticaria, pruritus, and its use as a probe drug in drug interaction and hemodialysis pharmacokinetic evaluations. Sponsored by academic medical centers and major pharmaceutical corporations, these protocols encompass completed, active, recruiting, and terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05263206 RECRUITING
Pruritus
Sanofi
 2022-02-15 PHASE3
NCT07526558 NOT_YET_RECRUITING
Post-tick Bite Illness; Mast Cell Stabilizer
University of North Carolina, Chapel Hill
 2026-04-30 PHASE2
NCT06152497 RECRUITING
Histamine
University Ghent
 2023-09-01
NCT06548204 RECRUITING
ST-segment Elevation Myocardial Infarction (STEMI)
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-01-20 PHASE2
NCT06785298 RECRUITING
Parkinson Disease
Tanta University
 2024-12-10 PHASE2; PHASE3
NCT07381803 RECRUITING
Zhejiang University
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-01-27 PHASE3
NCT02966665 RECRUITING
Chronic Obstructive Pulmonary Disease; Pulmonary Artery Hypertension; Heart Failure; Hypertension
Russell Richardson
 2008-09 PHASE1
NCT07118215 COMPLETED
Healthy Volunteers
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
 2025-09-29 PHASE1
NCT04688788 ACTIVE_NOT_RECRUITING
Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis
Rigshospitalet, Denmark
 2021-04-28 PHASE3
NCT05720455 COMPLETED
Rhinitis Allergic
Sanofi
 2025-06-15 PHASE4
NCT05264025 RECRUITING
Rheumatoid Arthritis
October 6 University
 2022-06-01 PHASE1; PHASE2
NCT07487909 COMPLETED
Healthy
Sen-Jam Pharmaceutical
 2025-09-30 PHASE1; PHASE2
NCT05118672 COMPLETED
Cold; Flu Symptom
Eurofarma Laboratorios S.A.
 2025-03-26 PHASE3
NCT04534153 COMPLETED
The Impact of Excipients on Drug Absorption
University of California, San Francisco
 2023-01-31 EARLY_PHASE1
NCT06779253 COMPLETED
Healthy Subjects
Abbisko Therapeutics Co, Ltd
 2025-03-14 PHASE1
NCT06205381 COMPLETED
Healthy Participants
Aeovian Pharmaceuticals, Inc.
 2024-01-31 PHASE1
NCT06019728 COMPLETED
Fabry's Disease
Sanofi
 2023-11-10 PHASE4
NCT06466421 COMPLETED
Uremic Pruritus; Chronic Kidney Disease-associated Pruritus; Hemodialysis; End-stage Renal Disease; Renal Replacement Therapy; ESRD
Tanta University
 2024-07-01 PHASE4
NCT04726345 COMPLETED
Nephrolithiasis
Columbia University
 2021-06-29 PHASE2
NCT06284902 COMPLETED
Healthy Volunteers
Opella Healthcare Group SAS, a Sanofi Company
 2024-02-23 PHASE1
NCT03720366 COMPLETED
Leukemia, Myeloid, Acute
Celgene
 2018-10-04 PHASE1
NCT05932277 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2023-06-29 PHASE1
NCT05692154 COMPLETED
Seasonal Allergic Rhinitis
Opella Healthcare Group SAS, a Sanofi Company
 2023-01-23 PHASE3
NCT05461456 COMPLETED
Atopic Dermatitis; Atopic Dermatitis Eczema; Atopic Rash; Rash; Pruritus; Urticaria; Urticaria Chronic; Psoriasis; Psoriasis Vulgaris; Skin Rash; Skin Inflammation; Eczema
OrchestratePharma GmbH
 2022-04-01 PHASE1
NCT04224428 COMPLETED
Diabetic Kidney Disease
Tanta University
 2020-01-01 PHASE3
NCT03994731 COMPLETED
Gout
Amgen
 2019-06-13 PHASE4
NCT03078777 UNKNOWN
Hemodialysis
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2017-11-29 PHASE4
NCT04450134 COMPLETED
Exercise Training; Physical Activity
University Ghent
 2019-10-02
NCT03933007 TERMINATED
Gout Flare
Assistance Publique - Hôpitaux de Paris
 2019-09-10 PHASE4
NCT03796377 Completed
Drug Interaction Study
Insel Gruppe AG University Hospital Bern|Bayer
 2019-02-13 Phase 1
NCT03425097 TERMINATED
Gastroesophageal Reflux
Stanford University
 2018-02-07 PHASE2
NCT03664882 COMPLETED
Rhinitis Seasonal
Sanofi
 2018-09-17 PHASE3
NCT03078777 Unknown status
Hemodialysis
Lawson Health Research Institute
 2017-11-29 Phase 4
NCT03183297 UNKNOWN
Veisalgia
Sen-Jam Pharmaceutical
 2017-08 PHASE1
NCT02908750 COMPLETED
Non Small Cell Lung Cancer
AstraZeneca
 2017-03-02 PHASE1
NCT03108274 COMPLETED
Healthy
Alexion Pharmaceuticals, Inc.
 2017-04-18 PHASE1
NCT03012763 COMPLETED
Pharmacokinetics; Magnetic Resonance Imaging; Administration, Oral
University Medicine Greifswald
 2016-04 PHASE1
NCT01852318 UNKNOWN
Uremic Pruritus
National Taiwan University Hospital
 2014-04 PHASE4
NCT02551536 COMPLETED
Allergic Rhinitis
Indira Gandhi Medical College, Shimla
 2014-04 PHASE4
NCT02391688 COMPLETED
Drug Interaction
Jules Desmeules
 2014-11 PHASE1
NCT02157558 COMPLETED
Drug Interactions
Lexicon Pharmaceuticals
 2014-07 PHASE1
NCT02175485 COMPLETED
Rhinitis Allergic
Sanofi
 2014-06 PHASE4
NCT01940393 COMPLETED
Urticaria
Grupo de Alergología Clínica y Experimental
 2013-08 PHASE4
NCT02056743 COMPLETED
Healthy
Chonbuk National University Hospital
 2013-09 PHASE1
NCT01856348 COMPLETED
Physiological Effects of Vitamin D
University of Zurich
 2013-05 PHASE1
NCT01767272 COMPLETED
Healthy
Damanhour University
 2012-12
NCT01469234 COMPLETED
Rhinitis
Bayer
 2011-10 PHASE4
NCT01586091 COMPLETED
Pruritus; Chronic Urticaria; Allergic Rhinitis
Charite University, Berlin, Germany
 2011-02 PHASE4
NCT01683552 COMPLETED
ITCH
Campus Bio-Medico University
 2010-09 PHASE2
NCT01244230 COMPLETED
Atopic Dermatitis
Sanofi
 2010-11 PHASE2; PHASE3
NCT01244217 COMPLETED
Rhinitis Perennial
Sanofi
 2010-10 PHASE2; PHASE3
NCT01306721 COMPLETED
Rhinitis Seasonal
Sanofi
 2011-02 PHASE3
NCT01888718 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2011-02 PHASE1
NCT01172522 COMPLETED
Edema
The Connecticut Sinus Center, PC
 2010-09 PHASE2
NCT01298505 TERMINATED
Healthy
Pfizer
 2010-06-04 PHASE1
NCT01033396 COMPLETED
Allergic Rhinitis
Pfizer
 2010-01 PHASE2
NCT01526213 COMPLETED
Food-drug Interaction
University of North Carolina, Chapel Hill
 2009-09
NCT02171546 TERMINATED
Healthy
Boehringer Ingelheim
 2007-11 PHASE1
NCT00502775 COMPLETED
Rhinitis, Allergic, Seasonal
GlaxoSmithKline
 2007-08 PHASE4
NCT01133483 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2007-04 PHASE1
NCT00435461 COMPLETED
Rhinitis, Allergic, Seasonal
GlaxoSmithKline
 2006-12-20 PHASE4
NCT01133470 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2007-02 PHASE1
NCT00783211 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2004-08-01 PHASE4
NCT00783146 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2004-08-01 PHASE4
NCT00741897 COMPLETED
Rhinitis, Allergic, Perennial
Sanofi
 2002-03 PHASE4
NCT00045955 COMPLETED
Asthma
Sanofi
 2002-02 PHASE3
NCT00649376 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2003-10 PHASE1
NCT00647985 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2003-11 PHASE1
NCT00044824 COMPLETED
Asthma
Sanofi
 2002-02 PHASE3
NCT00044811 COMPLETED
Asthma
Sanofi
 2002-03 PHASE3
NCT00794768 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2002-11 PHASE4
NCT00783133 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2002-11-01 PHASE4
NCT00794248 COMPLETED
Seasonal Allergic Rhinitis
Organon and Co
 2002-11 PHASE4
NCT00542607 COMPLETED
Rhinitis, Allergic, Seasonal
UCB Pharma
 2002-09 PHASE4
NCT01066754 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-04 PHASE1
NCT01066767 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2002-04 PHASE1
NCT00835276 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-03 PHASE1
NCT00835640 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2002-01 PHASE1
NCT00636870 COMPLETED
Allergic Rhinitis
Sanofi
 2003-02 PHASE4
NCT00637455 COMPLETED
Seasonal Allergic Rhinitis
Sanofi
 2003-09 PHASE4
NCT00261079 COMPLETED
Pruritus
Handok Inc.
 2005-04 PHASE4
NCT00637611 COMPLETED
Seasonal Allergic Rhinitis
Sanofi
 2003-02 PHASE4
NCT00638118 COMPLETED
Allergic Rhinitis
Sanofi
 2003-02 PHASE4
NCT00547768 COMPLETED
Allergy
Sanofi
 2002-11 PHASE4
NCT00420082 COMPLETED
Seasonal Allergic Rhinitis
Faes Farma, S.A.
 2006-10 PHASE2
NCT00637884 COMPLETED
Cat Induced Allergic Rhinitis
Sanofi
 2003-11 PHASE4
NCT00637585 COMPLETED
Allergic Rhinitis
Sanofi
 2002-12 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-07-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fexofenadine functions as a selective peripheral histamine H1 receptor antagonist that selectively binds to the receptor and blocks histamine-mediated downstream signal transduction in vascular and immune cells. By suppressing histamine-induced endothelial permeability, smooth muscle constriction, and sensory nerve stimulation, this blockade inhibits acute inflammatory responses to relieve symptoms of seasonal allergic rhinitis, chronic urticaria, and pruritus.

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>).

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