Clinical Trials

Numerous clinical trials, spanning early phase through Phase 4, investigate histamine and its metabolic pathways across conditions such as allergic rhinitis, pruritus, chronic urticaria, hyper-IgE syndrome, gastroesophageal reflux disease, and small cell lung cancer. Sponsored by academic centers, pharmaceutical corporations, and government entities, these studies encompass active, recruiting, completed, and terminated recruitment stages. Together, they evaluate therapeutic antihistamines, histamine-induced physiological responses, and the compound's role in immune and respiratory diseases.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07785609 NOT_YET_RECRUITING
Advanced Solid Tumors; Malignant Neoplasm
Merck Sharp & Dohme LLC
 2026-09-30 PHASE2
NCT07395882 NOT_YET_RECRUITING
Itching
Aalborg University
 2026-02-15
NCT06406114 RECRUITING
Drug Allergy; Cephalosporin Allergy; Drug Hypersensitivity; Antibiotic Allergy; Beta Lactam Adverse Reaction; Drug-Induced Anaphylaxis; Cephalosporin Reaction
Massachusetts General Hospital
 2025-05-05 PHASE2
NCT07268248 NOT_YET_RECRUITING
Allergic Reaction to Contrast Media; Hypersensitivity Reaction; Computed Tomography; Premedication
Paul Peng, MD PhD MSCR
 2026-06
NCT03647072 RECRUITING
Lymphoma
Sherief Abd-Elsalam
 2018-08-01 PHASE3
NCT05319730 RECRUITING
Esophageal Squamous Cell Carcinoma
Merck Sharp & Dohme LLC
 2023-05-16 PHASE1; PHASE2
NCT05810792 NOT_YET_RECRUITING
Pancreatic Cancer; Surgery; Metastasis; Immunosuppression
Sahlgrenska University Hospital
 2024-04-01 PHASE2
NCT06632405 NOT_YET_RECRUITING
Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2025-04-01 PHASE2
NCT07765979 RECRUITING
Urticaria Chronic
Saglik Bilimleri Universitesi
 2025-11-23
NCT07122973 RECRUITING
Pain; Itch
Aalborg University
 2025-09-17
NCT07203274 NOT_YET_RECRUITING
Itchiness
Aalborg University
 2026-05-01
NCT06152497 RECRUITING
Histamine
University Ghent
 2023-09-01
NCT07247695 RECRUITING
ITCH
Aalborg University
 2025-11-03
NCT07755930 NOT_YET_RECRUITING
Marsili Syndrome
Aalborg University
 2026-08-01
NCT07255092 NOT_YET_RECRUITING
ITCH
Aalborg University
 2025-12-01
NCT07341776 RECRUITING
Anaphylactic Reaction; Anaphylaxis; Allergy in Children; IgE Mediated Food Allergy
Johannes Trueck
 2026-01-26 PHASE4
NCT07632040 ENROLLING_BY_INVITATION
Pediatric Chronic Spontaneous Urticaria
Istanbul University
 2025-11-24
NCT07294326 NOT_YET_RECRUITING
Allergic Rhinitis
China-Japan Union Hospital
 2026-01-01 PHASE4
NCT03770923 RECRUITING
Rheumatoid Arthritis
Sherief Abd-Elsalam
 2018-10-01 PHASE3
NCT07736651 RECRUITING
Psoriasis
Mahmoud Usama Mahmoud Ahmed
 2026-08-01
NCT04612803 WITHDRAWN
Irritable Bowel Syndrome; Dermatographism; Post-prandial Diarrhea
University of Cincinnati
 2020-02-01 PHASE3
NCT07285031 RECRUITING
Histamine; Exercise
University of British Columbia
 2025-12
NCT04699604 COMPLETED
Allergic Asthma
Bridgette Jones
 2021-04-28 PHASE3
NCT04743661 ACTIVE_NOT_RECRUITING
Recurrent Medulloblastoma; Recurrent Ependymoma
Pediatric Brain Tumor Consortium
 2022-04-04 PHASE2
NCT07114107 NOT_YET_RECRUITING
Atopic Rhinitis; Atopic Asthma
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2025-08
NCT07195929 NOT_YET_RECRUITING
Allergic Reactions; Allergic Skin Reaction
Inmunotek S.L.
 2025-11
NCT07017231 ACTIVE_NOT_RECRUITING
Itching
Aalborg University
 2025-05-15
NCT05206227 ACTIVE_NOT_RECRUITING
Postexercise Hypotension
University of Oregon
 2021-07-28 EARLY_PHASE1
NCT06328530 RECRUITING
Histamine; Cowhage
Aalborg University
 2024-04-01
NCT06340438 RECRUITING
Histamine; Cowhage
Aalborg University
 2024-04-27
NCT06503523 RECRUITING
Itch; Pain
Aalborg University
 2024-10-01
NCT06503510 RECRUITING
Itch
Aalborg University
 2025-01-06
NCT06328543 RECRUITING
Histamine; Cowhage
Aalborg University
 2024-11-01
NCT05532566 RECRUITING
Allergic Reaction; Allergic Skin Reaction; Allergy Pollen
Inmunotek S.L.
 2023-01-24
NCT04568902 COMPLETED
Breast Neoplasms
Eisai Co., Ltd.
 2020-09-30 PHASE1
NCT06081946 RECRUITING
Histamine; Cowhage; Sleep Fragmentation
Aalborg University
 2023-12-15
NCT07778472 COMPLETED
Healthy
Palm Beach Atlantic University
 2025-02-24 EARLY_PHASE1
NCT06272032 UNKNOWN
Allergic Rhinitis
Chongqing Medical University
 2023-08-01 EARLY_PHASE1
NCT07397962 COMPLETED
Histamin Intolerance
University of Hohenheim
 2024-05-02
NCT06250400 UNKNOWN
Chronic Spontaneous Urticaria
Hangzhou Grand Biologic Pharmaceutical, Inc.
 2024-03-31 PHASE4
NCT04548999 ACTIVE_NOT_RECRUITING
Multiple Sclerosis
Hoffmann-La Roche
 2020-12-03 PHASE3
NCT07501520 COMPLETED
Multiple Sclerosis (MS) - Relapsing-remitting; Mediterranean Diet
Firat University
 2024-06-15
NCT06957496 COMPLETED
Allergy Pollen; Allergic Reaction; Allergic Skin Reaction
Inmunotek S.L.
 2024-12-09
NCT05832528 UNKNOWN
Functional Gastrointestinal Disorders
Universitaire Ziekenhuizen KU Leuven
 2022-10-03
NCT06154824 COMPLETED
Histamine; Cowhage
Aalborg University
 2023-12-15
NCT06126991 UNKNOWN
Burns
Ruijin Hospital
 2024-01-23 PHASE1; PHASE2
NCT06245564 COMPLETED
Itch
Aalborg University
 2024-08-20
NCT06081998 RECRUITING
Histamine; Cowhage; Sleep Deprivation
Aalborg University
 2023-11-01
NCT04544436 ACTIVE_NOT_RECRUITING
Multiple Sclerosis
Hoffmann-La Roche
 2020-11-26 PHASE3
NCT06470737 COMPLETED
Itch; Pain
Aalborg University
 2024-07-01
NCT06629337 COMPLETED
Prehypertension (elevated Blood Pressure) or Hypertension
California Baptist University
 2024-04-01
NCT07006558 COMPLETED
Histamine Intolerance
AB Biotek
 2023-06-23
NCT05849675 COMPLETED
Anhedonia; Cognitive Function
University of Oxford
 2023-04-01
NCT06281366 Recruiting
Pregnancy Complications
Hospital Universitari Vall d''Hebron Research Institute|DR Healthcare
 2024-02-16 --
NCT05533385 COMPLETED
Allergy Pollen; Allergic Reaction; Allergic Skin Reaction
Inmunotek S.L.
 2023-10-10
NCT05195177 UNKNOWN
Itch
Aalborg University
 2021-11-25
NCT06406153 COMPLETED
Mucopolysaccharidosis Type 1
Cinnagen
 2022-09-10 PHASE3
NCT03554291 COMPLETED
Pulmonary Arterial Hypertension; Right Heart Failure
University of Washington
 2019-05-01 PHASE2
NCT02688985 COMPLETED
Relapsing Multiple Sclerorsis; Multiple Sclerosis, Primary Progressive
Genentech, Inc.
 2016-04-29 PHASE3
NCT05654298 COMPLETED
Migraine
Universitaire Ziekenhuizen KU Leuven
 2022-03-15
NCT05216133 Enrolling by invitation
Airway Disease|Barrett Esophagus|Gastroesophageal Reflux Disease
NYU Langone Health|National Institute for Occupational Safety and Health (NIOSH/CDC)
 2023-03-22 --
NCT02889159 COMPLETED
Photoaged Skin; Normal Skin
University of Michigan
 2016-06-06 PHASE1
NCT05701826 Completed
Skeletal Muscle Relaxation
Fujian Shengdi Pharmaceutical Co. Ltd.
 2023-02-15 Phase 1
NCT01059786 ACTIVE_NOT_RECRUITING
Hairy Cell Leukemia
National Cancer Institute (NCI)
 2010-07-01 PHASE2
NCT01908465 COMPLETED
Irritable Bowel Syndrome (IBS)
KU Leuven
 2013-11 PHASE4
NCT04764383 WITHDRAWN
Multiple Sclerosis
University of Miami
 2022-01-01 PHASE2
NCT05676346 Completed
Lower Urinary Tract Symptoms|Histamine Intolerance
Complexo Hospitalario Universitario de A Coruña
 2022-10-11 --
NCT05369338 COMPLETED
Healthy Volunteers
Medical University of Graz
 2022-05-06
NCT03258593 COMPLETED
Urinary Bladder Neoplasms
National Cancer Institute (NCI)
 2018-06-07 PHASE1
NCT03554473 COMPLETED
Carcinoma, Small Cell; Lung Cancer; Small Cell Lung Cancer
National Cancer Institute (NCI)
 2018-09-11 PHASE1; PHASE2
NCT04672382 COMPLETED
Morphine; Histamine; Cowhage; Isotonic Saline
Aalborg University
 2021-07-01
NCT04554888 COMPLETED
Itch
Aalborg University
 2022-03-01
NCT03050866 UNKNOWN
Circulating Tumor Cell; Metastatic Prostate Cancer
Erasmus Medical Center
 2017-02-21 PHASE2
NCT04700007 COMPLETED
Itch
Aalborg University
 2021-01-18
NCT05131555 COMPLETED
Exercise; Histamine
University Ghent
 2021-08-16
NCT04635254 COMPLETED
Pain, Acute; Itch
Aalborg University
 2020-11-12
NCT01601522 COMPLETED
Peanut Allergy
Hamilton Health Sciences Corporation
 2012-02 PHASE2
NCT04676763 COMPLETED
Skin Diseases
GlaxoSmithKline
 2021-03-02
NCT04711044 COMPLETED
Itch
Aalborg University
 2021-02-01
NCT03943407 WITHDRAWN
Itch
Aalborg University
 2019-11-01
NCT04935515 COMPLETED
COVID -19
Manimarane Arjunan, MD,DM (Cardiology)
 2021-04-15
NCT04588532 COMPLETED
Itch
Aalborg University
 2020-10-01
NCT04540965 COMPLETED
Drug Interaction
Calithera Biosciences, Inc
 2020-09-22 PHASE1
NCT04076865 COMPLETED
Lidocaine; Itch
Aalborg University
 2019-10-15
NCT03266965 COMPLETED
Multiple Sclerosis
University of Miami
 2018-03-23 PHASE1
NCT05022108 COMPLETED
Wounds and Injuries
Universidade do Vale do Sapucai
 2020-04-01 PHASE1
NCT04115462 COMPLETED
Morphine; Itch
Aalborg University
 2020-01-15
NCT04399525 COMPLETED
Pruritus
Universitaire Ziekenhuizen KU Leuven
 2019-10-28
NCT03590912 COMPLETED
Otitis Media With Effusion
Lumbini Medical College
 2018-09-05 PHASE4
NCT05276336 COMPLETED
Allergic Rhinitis
Indonesia University
 2018-07-01 PHASE3
NCT04450134 COMPLETED
Exercise Training; Physical Activity
University Ghent
 2019-10-02
NCT04179461 COMPLETED
Asthma in Children
Children's Hospital Medical Center, Cincinnati
 2018-03-16 PHASE2
NCT04399148 COMPLETED
Pruritus
Universitaire Ziekenhuizen KU Leuven
 2019-06-11
NCT03587220 COMPLETED
Capsaicin; Ultaviolet B Light Burn; Neuropathic Pain; Lidocaine
Aalborg University
 2018-08-01
NCT04058054 COMPLETED
Hypersensitivity
KeraNetics, LLC
 2019-07-29
NCT03826004 COMPLETED
Efficacy and Safety
Chinese Academy of Medical Sciences, Fuwai Hospital
 2019-02-20
NCT03576053 COMPLETED
Itch; Thermal Stimulation; Histamine; Cowhage; Serotonine
Aalborg University
 2018-07-01
NCT03805035 COMPLETED
Pain
China Medical University Hospital
 2019-01-24
NCT04396977 COMPLETED
Pruritus
Universitaire Ziekenhuizen KU Leuven
 2019-02-28
NCT03583567 COMPLETED
Protamine Adverse Reaction
Mahidol University
 2018-09-05 PHASE4
NCT01925729 COMPLETED
Middle Ear Disease; Nasal Allergy
Cuneyt M. Alper
 2013-10-01 PHASE1
NCT04399213 COMPLETED
Pruritus
Universitaire Ziekenhuizen KU Leuven
 2019-01-15
NCT03040401 UNKNOWN
Leukemia, Myelomonocytic, Chronic
Vastra Gotaland Region
 2017-02-15 PHASE1; PHASE2
NCT03145012 COMPLETED
Cancer
Nova Scotia Health Authority
 2018-05-01 PHASE4
NCT02527122 COMPLETED
Immune System Diseases
Inmunotek S.L.
 2016-07-21
NCT02047136 TERMINATED
Diet Modification; Chronic Urticaria
Hong Kong Sanatorium & Hospital
 2013-09
NCT02418312 COMPLETED
Peptic Ulcer
Kaohsiung Veterans General Hospital.
 2012-01
NCT02882217 COMPLETED
Asthma
EURRUS Biotech GmbH
 2016-08 PHASE1
NCT02604199 TERMINATED
Hepatitis B
Arrowhead Pharmaceuticals
 2015-09 PHASE2
NCT02738008 TERMINATED
Hepatitis B
Arrowhead Pharmaceuticals
 2016-03 PHASE2
NCT02577029 TERMINATED
Hepatitis B; Hepatitis D
Arrowhead Pharmaceuticals
 2015-12 PHASE2
NCT02604212 TERMINATED
Hepatitis B
Arrowhead Pharmaceuticals
 2015-11 PHASE2
NCT02797522 TERMINATED
Hepatitis B
Arrowhead Pharmaceuticals
 2016-06 PHASE1
NCT01112722 COMPLETED
Osteoarthritis of the Knee
Apimeds, Inc.
 2013-12 PHASE3
NCT01946295 UNKNOWN
Schizophrenia
Jesper Ekelund
 2014-03 PHASE2; PHASE3
NCT02769910 COMPLETED
Pruritus
Hjalte Holm Andersen
 2016-05 PHASE1; PHASE2
NCT02364453 COMPLETED
Migraine Without Aura
Song Guo
 2015-02
NCT02613910 TERMINATED
Pemphigus
GlaxoSmithKline
 2015-12-23 PHASE3
NCT01777464 TERMINATED
House Dust Mite Allergy
Universitaire Ziekenhuizen KU Leuven
 2012-11
NCT04631276 COMPLETED
Healthy Subjects
Taisho Pharmaceutical Co., Ltd.
 2014-12-11 PHASE1
NCT02512653 COMPLETED
Allergy to Tree Pollen
Laboratorios Leti, S.L.
 2015-11 PHASE2
NCT01989897 WITHDRAWN
Allergic Rhinitis
Bryan Martin, DO
 2013-03 PHASE1; PHASE2
NCT03509766 COMPLETED
Allergic Rhinitis; Asthma; Food Allergy; Skin Testing
Johns Hopkins University
 2014-01
NCT02561429 COMPLETED
Immediate Hypersensitivity
Mahidol University
 2013-07
NCT01392859 COMPLETED
Asthma; Allergic Asthma; Non-allergic Asthma
Children's Mercy Hospital Kansas City
 2011-06 PHASE2; PHASE3
NCT02506998 COMPLETED
Allergic Rhinoconjunctivitis
National Polytechnic Institute, Mexico
 2013-08 PHASE2
NCT02142712 COMPLETED
Acute Cerebrovascular Accident; Cerebral Edema
University of Florida
 2014-12 PHASE2
NCT01984528 COMPLETED
Allergy to Alternaria Fungus
Laboratorios Leti, S.L.
 2014-02 PHASE2
NCT01984541 COMPLETED
Allergy to Pollen
Laboratorios Leti, S.L.
 2014-03 PHASE2
NCT01347996 COMPLETED
Acute Myeloid Leukemia
Cytovia, Inc.
 2009-07 PHASE4
NCT01985789 COMPLETED
Asthma
Don Cockcroft
 2013-11 PHASE4
NCT01675349 COMPLETED
Allergy to Chenopodium Album
Laboratorios Leti, S.L.
 2012-11 PHASE2
NCT01937494 COMPLETED
Asthma; Bronchial Hyperresponsiveness
Centre Hospitalier Universitaire Saint Pierre
 2013-05
NCT01981499 TERMINATED
Migraine
Pfizer
 2014-01 PHASE1
NCT01937078 COMPLETED
Dyskinesia
University Health Network, Toronto
 2011-04 PHASE2
NCT01963741 COMPLETED
Allergic Rhinitis; Asthma
Guangzhou Institute of Respiratory Disease
 2012-11
NCT01940393 COMPLETED
Urticaria
Grupo de Alergología Clínica y Experimental
 2013-08 PHASE4
NCT01661777 WITHDRAWN
Eustachian Tube Dysfunction; Endolymphatic Hydrops
Vanderbilt University
 2012-08
NCT01833156 COMPLETED
Lymphedema
Nij Smellinghe Hosptial
 2013-03
NCT00886795 COMPLETED
Urticaria
Johns Hopkins University
 2009-05 PHASE1; PHASE2
NCT01382940 COMPLETED
Rheumatoid Arthritis
Hoffmann-La Roche
 2011-07-26 PHASE4
NCT00771875 COMPLETED
Graft Rejection
University of Cincinnati
 2008-09 PHASE2
NCT01380678 UNKNOWN
Pterygium; Inflammation
Khon Kaen University
 2009-01 PHASE3
NCT01264939 COMPLETED
Chronic Idiopathic Urticaria
Genentech, Inc.
 2011-02 PHASE3
NCT01689363 COMPLETED
Allergic Skin Reaction
Amphastar Pharmaceuticals, Inc.
 2012-09 PHASE2
NCT01673529 COMPLETED
Dermatitis, Atopic
GlaxoSmithKline
 2012-07-17 PHASE1
NCT01737931 COMPLETED
Healthy
Otsuka Pharmaceutical Co., Ltd.
 2012-08 PHASE1
NCT01597752 COMPLETED
Allergy to Mites
Laboratorios Leti, S.L.
 2012-04 PHASE2
NCT01407835 COMPLETED
Allergy to Grass Pollen (Dactylis Glomerata)
Laboratorios Leti, S.L.
 2011-10 PHASE2
NCT01408238 COMPLETED
Allergy to Grass Pollen (Secale Cereale)
Laboratorios Leti, S.L.
 2011-10 PHASE2
NCT01430117 COMPLETED
Allergy to Grass Pollen
Laboratorios Leti, S.L.
 2011-10 PHASE2
NCT00565175 COMPLETED
Schizophrenia
Jesper Ekelund
 2008-01 PHASE4
NCT01586091 COMPLETED
Pruritus; Chronic Urticaria; Allergic Rhinitis
Charite University, Berlin, Germany
 2011-02 PHASE4
NCT01402141 COMPLETED
Healthy Subjects
Chonbuk National University Hospital
 2010-10 PHASE2; PHASE3
NCT00527878 TERMINATED
JOB's Syndrome; Hyper-IgE Recurrent Infection Syndrome; Immune Deficiency
National Institute of Allergy and Infectious Diseases (NIAID)
 2007-09 PHASE2
NCT01194986 COMPLETED
Brain Distribution of [11C]AZ12807110 and AZD5213
AstraZeneca
 2010-11 PHASE1
NCT00719472 COMPLETED
Non-Hodgkin's Lymphoma
Genentech, Inc.
 2008-07 PHASE3
NCT01292070 TERMINATED
Cat Allergy
National Institute of Allergy and Infectious Diseases (NIAID)
 2011-03 EARLY_PHASE1
NCT01507792 COMPLETED
Cough; Laryngeal Disease; Bronchial Disease; Iron Deficiency
University of Turin, Italy
 2002-01
NCT01128556 COMPLETED
Histamine Responsive Allergy Patients
North Texas Institute for Clinical Trials
 2010-04 PHASE4
NCT00917488 COMPLETED
Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic
Laboratorios Leti, S.L.
 2009-05 PHASE2
NCT00949754 COMPLETED
Osteoarthritis of the Knee
Apimeds, Inc.
 2009-10 PHASE2
NCT00675090 COMPLETED
Alzheimer's Disease
GlaxoSmithKline
 2008-02-21 PHASE1
NCT00775658 COMPLETED
Allergic Rhinitis; Allergic Conjunctivitis
Vanderbilt University Medical Center
 2008-01
NCT00809692 WITHDRAWN
Histamine Biotransformation
Children's Mercy Hospital Kansas City
 2007-09
NCT00630383 WITHDRAWN
Multiple Sclerosis
University of Nottingham
 2008-02 PHASE2
NCT00537355 COMPLETED
Rhinitis, Allergic, Seasonal
Dynavax Technologies Corporation
 2007-09 PHASE2
NCT00474513 COMPLETED
Mild Cognitive Impairment; Dementia
GlaxoSmithKline
 2007-03 PHASE1
NCT01719133 COMPLETED
Allergic Rhinitis
Anergis
 2008-02 PHASE1
NCT00366080 TERMINATED
Narcolepsy
GlaxoSmithKline
 2006-11 PHASE2
NCT02318043 COMPLETED
Asthma
Guangzhou Institute of Respiratory Disease
 2007-01
NCT00387413 COMPLETED
Hyperalgesia
GlaxoSmithKline
 2006-10-02 PHASE1
NCT00387738 TERMINATED
Rhinitis, Allergic, Seasonal
Dynavax Technologies Corporation
 2006-04 PHASE2
NCT00208065 COMPLETED
Migraine; Sinusitis
Clinvest
 2004-05 PHASE4
NCT00150761 COMPLETED
Anti-allergic Agents
UCB Pharma
 2004-07 PHASE4
NCT00154024 COMPLETED
Healthy Subjects
Technische Universität Dresden
 2003-03
NCT00637585 COMPLETED
Allergic Rhinitis
Sanofi
 2002-12 PHASE4
NCT01068223 COMPLETED
Histamine Induced Itch
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-02 PHASE1
NCT00000363 COMPLETED
Otitis Media
National Institute on Deafness and Other Communication Disorders (NIDCD)
 PHASE3
NCT00253942 UNKNOWN
Persons With Mild to Moderate Knee Osteoarthritis
Rheumatology Therapeutics Medical Center
 2005-11 PHASE3
NCT00039234 UNKNOWN
Melanoma (Skin); Metastatic Cancer
Maxim Pharmaceuticals
 2002-09 PHASE3
NCT00003991 COMPLETED
Leukemia
Maxim Pharmaceuticals
 1998-07 PHASE3
NCT00005038 UNKNOWN
Kidney Cancer
The Christie NHS Foundation Trust
 1999-06 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Histamine selectively binds to and activates H1 and H2 G-protein-coupled receptors, triggering downstream phosphoinositide hydrolysis, intracellular calcium mobilization, and cyclic AMP elevation. This receptor activation induces smooth muscle contraction, increased vascular permeability, and gastric acid secretion, which directly correlates with its involvement in clinical trials evaluating allergic rhinitis, pruritus, and gastrointestinal physiological responses.

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.