Clinical Trials

Numerous clinical trials evaluate indomethacin across early through late development phases, assessing its therapeutic efficacy for post-endoscopic retrograde cholangiopancreatography pancreatitis, neonatal patent ductus arteriosus, migraine headaches, and cervical insufficiency. These protocols—encompassing active, completed, and withdrawn recruitment statuses—include targeted evaluations of optimal suppository dosing for pancreatitis prevention and pharmacokinetics in premature infants. Sponsored by diverse academic medical centers and industry entities, these studies reflect a broad research profile.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07661498 NOT_YET_RECRUITING
Pancreatitis Biliary; Pancreatitis Acute Biliary; Pancreatitis; Post-ERCP Pancreatitis; Post-ERCP Acute Pancreatitis; Post-ERCP Adverse Events
University of California, San Francisco
 2026-07 PHASE4
NCT07218653 NOT_YET_RECRUITING
Metabolic Syndrome
University of Wisconsin, Madison
 2026-09 EARLY_PHASE1
NCT00262470 ACTIVE_NOT_RECRUITING
Tachycardia; Chronic Orthostatic Intolerance
Satish R. Raj
 1997-04 PHASE1; PHASE2
NCT07330284 RECRUITING
Pancreatitis; ERCP Surgery
University of Kansas Medical Center
 2025-12-05
NCT07560566 RECRUITING
Hepato Cellular Carcinoma (HCC); Hand Foot Skin Syndrome
National Taiwan University Hospital
 2025-12-09 PHASE2
NCT06572917 NOT_YET_RECRUITING
Extreme Prematurity; Intraventricular Hemorrhage; Morbidity;Newborn
University of British Columbia
 2025-11-01 PHASE2
NCT07247682 NOT_YET_RECRUITING
Post-ERCP Pancreatitis
The First Affiliated Hospital of Anhui Medical University
 2025-12-01 PHASE4
NCT07776561 RECRUITING
Post-ERCP Pancreatitis; Pancreatitis
Westmead Hospital
 2026-06-01
NCT03547232 RECRUITING
Acute Pancreatitis; Complication; Mortality Rate; Organ Failure, Multiple
Peking Union Medical College Hospital
 2024-12-01 PHASE4
NCT07495111 RECRUITING
Cholelithiasis Associated With Common Bile Duct Stones
Qilu Hospital of Shandong University
 2025-12-01
NCT07536425 NOT_YET_RECRUITING
Pain; Oocyte Retrieval
Western Galilee Hospital-Nahariya
 2026-04-13 PHASE4
NCT06837831 RECRUITING
Rectal Cancer, Radiotherapy; Anal Pain; Acute Radiation Dermatitis; Anal Canal
Qianfoshan Hospital
 2026-02-01
NCT07792668 NOT_YET_RECRUITING
Hysterosalpingography-Related Pain; Infertility
Balikesir University
 2026-09-01 PHASE3
NCT03713879 RECRUITING
Post ERCP Pancreatitis
Chinese University of Hong Kong
 2019-03-21 PHASE3
NCT07607990 RECRUITING
Prostate Cancer (Post Prostatectomy); Perioperative Anesthetic; Catheter-related Bladder Discomfort (CRBD)
Zhejiang University
 2026-01-01
NCT07071441 RECRUITING
ERCP; Pancreatitis; Non-steroidal Anti-inflammatory (NSAID); Indomethacin; Diclofenac
Air Force Military Medical University, China
 2025-06-01
NCT05252754 RECRUITING
Post-ERCP Acute Pancreatitis
Johns Hopkins University
 2023-01-18 PHASE3
NCT07088757 RECRUITING
Post-ERCP Pancreatitis
Changhai Hospital
 2025-09-15 PHASE4
NCT06623513 NOT_YET_RECRUITING
Pancreatitis, Acute; Cholangiopancreatography, Endoscopic Retrograde
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
 2024-10-01 PHASE2
NCT02205762 ACTIVE_NOT_RECRUITING
Langerhans Cell Histiocytosis
North American Consortium for Histiocytosis
 2016-11-02 PHASE2; PHASE3
NCT05538247 COMPLETED
Healthy
Mayo Clinic
 2023-04-13 EARLY_PHASE1
NCT07680985 COMPLETED
Adenomyosis
Wenzhou People's Hospital
 2023-07-20
NCT05035407 TERMINATED
Kita-kyushu Lung Cancer Antigen 1, Human
National Cancer Institute (NCI)
 2022-03-08 PHASE1
NCT02858310 COMPLETED
Papillomavirus Infections; Cervical Intraepithelial Neoplasia; Carcinoma In Situ; Vulvar Neoplasms; Vulvar Diseases
National Cancer Institute (NCI)
 2017-01-27 PHASE1; PHASE2
NCT05572788 UNKNOWN
Pancreatic Cyst; Pancreatitis, Acute
Orlando Health, Inc.
 2022-09-26
NCT06253702 COMPLETED
Cerebrovascular Disorders
University of Wisconsin, Madison
 2024-07-24 PHASE4
NCT04265053 COMPLETED
Cerebral Arterial Diseases
University of Wisconsin, Madison
 2021-04-12 EARLY_PHASE1
NCT07173179 COMPLETED
Post-ERCP Acute Pancreatitis
Duzce University
 2023-01-01 PHASE4
NCT05664074 COMPLETED
Post-ERCP Acute Pancreatitis
David Vitale MD
 2022-11-07 PHASE4
NCT06433453 UNKNOWN
Ovulation Disorder
University of Saskatchewan
 2024-04-22 PHASE4
NCT07599605 COMPLETED
Pancreatitis; ERCP
Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
 2024-03-04 PHASE3
NCT05999708 WITHDRAWN
Colitis, Ulcerative
GlaxoSmithKline
 2023-10-31 PHASE1
NCT05132829 UNKNOWN
Preterm Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Physiological Effects of Drugs; Uterine Cervical Incompetence; Anti-Bacterial Agents; Azithromycin; Cefazolin
Thomas Jefferson University
 2021-12-20 PHASE4
NCT05381428 COMPLETED
Pancreatitis, Acute
Azienda USL Reggio Emilia - IRCCS
 2022-05-13 PHASE3
NCT03648437 TERMINATED
Patent Ductus Arteriosus
University of Oulu
 2018-09-03 PHASE1
NCT05947461 TERMINATED
Post-ERCP Acute Pancreatitis; NSAIDs; Indomethacin; Diclofenac; Endoscopic Retrograde Cholangiopancreatography
Air Force Military Medical University, China
 2023-06-01
NCT05007522 COMPLETED
COVID-19 Respiratory Infection
Sen-Jam Pharmaceutical
 2022-05-03 PHASE3
NCT05857514 UNKNOWN
Post-ERCP Acute Pancreatitis
Moti Lal Nehru Medical College
 2023-05-10
NCT04404686 UNKNOWN
Obstetric Labor, Premature
Hadassah Medical Organization
 2020-10 PHASE2; PHASE3
NCT02935205 UNKNOWN
Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer
Mamta Parikh
 2017-01-17 PHASE1; PHASE2
NCT05722548 UNKNOWN
Pancreatectomy
Shanghai Jiao Tong University School of Medicine
 2023-02-01 PHASE2
NCT05637281 UNKNOWN
Acute Pancreatitis; Systemic Inflammatory Response Syndrome
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2022-12-11
NCT06031363 COMPLETED
Pancreatitis; Cholangiopancreatography, Endoscopic Retrograde; Indomethacin
The First Affiliated Hospital of Soochow University
 2022-11-01
NCT04726085 TERMINATED
Preterm Labor
Woman's
 2021-02-01
NCT03267680 TERMINATED
Cervical Squamous Cell Carcinoma In Situ; Vulvar High Grade Squamous Intraepithelial Lesion
University of Southern California
 2017-11-08 PHASE2
NCT04207060 COMPLETED
Chronic Pancreatitis
Mayo Clinic
 2020-07-15 PHASE1; PHASE2
NCT02476279 COMPLETED
Post-ERCP Pancreatitis
Medical University of South Carolina
 2015-09 PHASE3
NCT06031363 Completed
Pancreatitis|Cholangiopancreatography Endoscopic Retrograde|Indomethacin
The First Affiliated Hospital of Soochow University
 2022-11-01 Not Applicable
NCT04425993 UNKNOWN
Post-ERCP Acute Pancreatitis
Air Force Military Medical University, China
 2020-07-01
NCT05109143 COMPLETED
Pancreatoduodenectomy
Institute of Liver and Biliary Sciences, India
 2020-10-17
NCT02884219 COMPLETED
Patent Ductus Arteriosus
Radboud University Medical Center
 2016-12-23
NCT02609386 COMPLETED
Squamous Cell Carcinoma of the Oral Cavity
Brooklyn ImmunoTherapeutics, LLC
 2016-01-11 PHASE2
NCT01869361 WITHDRAWN
Preterm Labor
MetroHealth Medical Center
 2020-08-01 EARLY_PHASE1
NCT03643900 COMPLETED
Post-ERCP Pancreatitis; Pancreatitis, Acute Necrotizing
First People's Hospital of Hangzhou
 2018-08-08
NCT04025177 WITHDRAWN
Patent Ductus Arteriosus After Premature Birth
University of Manitoba
 2020-01 PHASE2
NCT04964180 COMPLETED
Post-Operative Pain
South Valley University
 2020-05-01
NCT04821323 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-03-10 EARLY_PHASE1
NCT04821323 Completed
Healthy
Janssen Research & Development LLC
 2021-03-10 Early Phase 1
NCT04145336 UNKNOWN
Post-ERCP Acute Pancreatitis
Air Force Military Medical University, China
 2019-10-15
NCT03662269 UNKNOWN
Refractory Chronic Cough
The First Affiliated Hospital of Guangzhou Medical University
 2018-10-22 PHASE3
NCT04344457 UNKNOWN
COVID-19
Perseverance Research Center, LLC
 2020-04-16 PHASE1; PHASE2
NCT01265849 COMPLETED
Squamous Cell Carcinoma of the Oral Cavity; Squamous Cell Carcinoma of the Soft Palate
CEL-SCI Corporation
 2010-12 PHASE3
NCT03985969 COMPLETED
Drug-drug Interaction
Genfit
 2019-09-23 PHASE1
NCT02620761 TERMINATED
Patent Ductus Arteriosus (PDA); Acute Kidney Injury (AKI)
Medical College of Wisconsin
 2019-02-06 PHASE2; PHASE3
NCT04025177 Withdrawn
Patent Ductus Arteriosus After Premature Birth
University of Manitoba|St. Boniface Hospital|Health Sciences Centre Winnipeg Manitoba|University at Buffalo
 2020-01 Phase 2
NCT01744314 UNKNOWN
Elbow Trauma Requiring Operative Management
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2012-11
NCT02221219 COMPLETED
Intraventricular Hemorrhage; Periventricular Leukomalacia; Brain Injury; Renal Injury
Hong Huang
 2014-08 PHASE1; PHASE2
NCT02438371 TERMINATED
Preterm Labor
The University of Texas Health Science Center, Houston
 2015-05 PHASE4
NCT03473665 TERMINATED
Ankylosing Spondylitis; Axial Spondyloarthritis
Columbia University
 2018-03-01 PHASE4
NCT02692391 COMPLETED
Acute Pancreatitis
University of Pittsburgh
 2013-07 PHASE3
NCT02797067 COMPLETED
Pancreatitis
Changhai Hospital
 2016-05-31 PHASE4
NCT02959112 TERMINATED
Pancreatitis, Acute
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2016-05
NCT03967483 Unknown status
Headache Migraine
Anne Ducros|French Society for the Study of Migraine Headache
 2019-06-01 --
NCT03562624 COMPLETED
Contraception
Bayer
 2018-06-22 PHASE2
NCT02950259 COMPLETED
Breast Neoplasm; Breast Neoplasm, Male; Triple Negative Breast Cancer
Providence Health & Services
 2017-02-09 PHASE1
NCT03129945 COMPLETED
Obstetric Labor, Premature
University of California, Irvine
 2017-01-17
NCT02653638 COMPLETED
Cerebrovascular Circulation
University of Wisconsin, Madison
 2016-06 EARLY_PHASE1
NCT03712241 COMPLETED
Healthy
Kowa Research Institute, Inc.
 2018-10-04 PHASE1
NCT03708458 UNKNOWN
Post-ERCP Pancreatitis
Grigore T. Popa University of Medicine and Pharmacy
 2017-04-01 PHASE4
NCT02849990 COMPLETED
Stage III Prostate Adenocarcinoma AJCC v7; Stage III Prostate Cancer AJCC v7; Stage IV Prostate Adenocarcinoma AJCC v7; Stage IV Prostate Cancer AJCC v7
University of Washington
 2017-03-09 PHASE2
NCT03533803 COMPLETED
Difficult Embryo Transfer
Cairo University
 2018-06-02 PHASE3
NCT03537144 TERMINATED
Patent Ductus Arteriosus
University of Tennessee
 2016-06 PHASE3
NCT02603822 COMPLETED
Impaired Small Intestinal Permeability
Mayo Clinic
 2015-08 PHASE1
NCT03597867 COMPLETED
Ocular Inflammation
University of Trieste
 2018-04-25 PHASE3
NCT03620825 COMPLETED
Dehydration; Indomethacin
Örebro University, Sweden
 2018-03-17
NCT01912716 COMPLETED
Post-ERCP Pancreatitis
Indiana University
 2013-07 PHASE2; PHASE3
NCT02947932 UNKNOWN
Pancreatitis, Acute; Gastrointestinal Disease
First Affiliated Hospital Xi'an Jiaotong University
 2016-12 PHASE4
NCT03629600 COMPLETED
Post-ERCP Acute Pancreatitis
Post Graduate Institute of Medical Education and Research, Chandigarh
 2017-10-15 PHASE2; PHASE3
NCT02964403 UNKNOWN
Pancreatitis, Acute
First Affiliated Hospital Xi'an Jiaotong University
 2016-12 PHASE4
NCT03057769 TERMINATED
Pancreatitis; Endoscopic Retrograde Cholangiopancreatography
Air Force Military Medical University, China
 2017-02-01
NCT02111707 COMPLETED
Acute Pancreatitis
University of Alberta
 2014-04 PHASE4
NCT01719926 COMPLETED
Colorectal Neoplasms; Esophageal Neoplasms; Ovarian Neoplasms
UMC Utrecht
 2012-09 PHASE1
NCT05584254 COMPLETED
Elderly; Bowel Symptoms; Prebiotics
Örebro University, Sweden
 2015-04-01
NCT00223691 COMPLETED
Autonomic Failure; Orthostatic Hypotension
Vanderbilt University
 2002-03 PHASE1
NCT02368795 UNKNOWN
Pancreatitis
Tehran University of Medical Sciences
 2015-02
NCT02633969 COMPLETED
Pain, Postoperative
Iroko Pharmaceuticals, LLC
 2015-12 PHASE2
NCT03261635 COMPLETED
Macular Edema
Università degli Studi di Brescia
 2016-01-07 PHASE4
NCT02116309 COMPLETED
Post-ERCP Acute Pancreatitis
Johns Hopkins University
 2014-08
NCT01733485 COMPLETED
Asthma; Electrophilic Fatty Acids
Sally E. Wenzel MD
 2011-10 PHASE1
NCT02711358 COMPLETED
Family Planning
Assiut University
 2016-03 PHASE4
NCT03582332 COMPLETED
Axial Spondyloarthritis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2016-01-02 PHASE4
NCT02641561 COMPLETED
Post-ERCP Acute Pancreatitis
The Cooper Health System
 2014-10 PHASE3
NCT01360034 UNKNOWN
Obstetric Labor, Premature
Saint Thomas Hospital, Panama
 2015-12 PHASE3
NCT02642601 UNKNOWN
Difficult Embryo Transfer
Cairo University
 2014-03 PHASE2; PHASE3
NCT02002650 COMPLETED
Post-ERCP Acute Pancreatitis
Air Force Military Medical University, China
 2013-12
NCT02577809 COMPLETED
Post-operative Pain
University of Witwatersrand, South Africa
 2015-07 PHASE4
NCT01848665 COMPLETED
Healthy Males; Neuromuscular Function
Brock University
 2013-05 PHASE4
NCT01830335 COMPLETED
Healthy Males; Neuromuscular Function
Brock University
 2013-04 PHASE4
NCT00466128 UNKNOWN
Preterm Premature Rupture of Membranes
Thomas Jefferson University
 2007-04 PHASE2
NCT02110810 COMPLETED
Post ERCP Acute Pancreatitis
Instituto Mexicano del Seguro Social
 2014-01 PHASE3
NCT01774604 TERMINATED
Post-ERCP Acute Pancreatitis
Dartmouth-Hitchcock Medical Center
 2013-01 PHASE3
NCT02361645 COMPLETED
Vitreous Inflammation
Università degli Studi di Brescia
 2014-03 PHASE3
NCT01957215 COMPLETED
Ankle Sprain
GlaxoSmithKline
 2013-10 PHASE4
NCT01577121 COMPLETED
Preterm Labor With Intact Membranes
Sara Varea
 2012-04 PHASE2
NCT01884272 COMPLETED
Gout
Ardea Biosciences, Inc.
 2013-06 PHASE1
NCT01114516 COMPLETED
Cervical Insufficiency
Northwestern University
 2010-03
NCT01742689 UNKNOWN
Renal Colic; Pain
Tehran University of Medical Sciences
 2012-03 PHASE3
NCT00750581 TERMINATED
Patent Ductus Arteriosus
University of Calgary
 2008-08 PHASE2; PHASE3
NCT00486824 COMPLETED
Obstetric Labor, Premature
Stanford University
 2007-04 PHASE1; PHASE2
NCT00478335 COMPLETED
Nephrogenic Diabetes Insipidus
University of Colorado, Denver
 2007-05
NCT01626118 COMPLETED
Other Acute Postoperative Pain
Iroko Pharmaceuticals, LLC
 2012-05 PHASE3
NCT00728117 COMPLETED
Patent Ductus Arteriosus
University of California, San Francisco
 2008-07
NCT01070745 WITHDRAWN
Patent Ductus Arteriosus
Shaare Zedek Medical Center
 2010-06 PHASE2
NCT01722110 COMPLETED
Fed
IPCA Laboratories Ltd.
 2012-04 PHASE1
NCT01543685 COMPLETED
Other Acute Postoperative Pain
Iroko Pharmaceuticals, LLC
 2012-02 PHASE3
NCT00033917 COMPLETED
Intraventricular Hemorrhage (IVH); Bleeding in the Brain; Prematurity; Very Low Birth Weight Infants
Yale University
 1989-09 PHASE3
NCT01758913 COMPLETED
Patent Ductus Arteriosus
Taipei Medical University Hospital
 2007-02
NCT01280006 COMPLETED
Obstructive Sleep Apnea; Hypertension; Cardiovascular Diseases; Stroke
University of Calgary
 2011-01 PHASE1; PHASE2
NCT00727740 COMPLETED
Pancreatitis
Yale University
 2005-08
NCT00820612 TERMINATED
Post-ERCP Pancreatitis
University of Michigan
 2009-01 PHASE4
NCT00997581 WITHDRAWN
Acute Gout
Dartmouth-Hitchcock Medical Center
 2010-04 PHASE2
NCT00210470 COMPLETED
Squamous Cell Carcinoma of the Head and Neck
Brooklyn ImmunoTherapeutics, LLC
 2005-07 PHASE2
NCT00616382 UNKNOWN
Patent Ductus Arteriosus
Shaare Zedek Medical Center
 2008-03 PHASE2
NCT00855920 COMPLETED
Acute Gout Flare
Regeneron Pharmaceuticals
 2009-03 PHASE3
NCT00549549 COMPLETED
Arthritis, Gouty
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2008-02 PHASE3
NCT00964431 COMPLETED
Dental Pain
Iroko Pharmaceuticals, LLC
 2009-08 PHASE2
NCT00226122 COMPLETED
Enuresis
University of Aarhus
 2003-01 PHASE4
NCT00722033 UNKNOWN
Regional Blood Flow; Premature Birth; Electroencephalography
Pontificia Universidad Catolica de Chile
 2008-08 PHASE2
NCT00904904 COMPLETED
Cataract; Inflammation
Bausch & Lomb Incorporated
 2008-04 PHASE4
NCT00470743 WITHDRAWN
Ductus Arteriosus, Patent; Very Low Birth Weight Infants
KK Women's and Children's Hospital
 2007-05 PHASE4
NCT00811057 COMPLETED
Preterm Labor
University of Mississippi Medical Center
 2004-06
NCT00462111 COMPLETED
Healthy
Sint Maartenskliniek
 2007-04 PHASE4
NCT00858195 COMPLETED
Inflammation
Sandoz
 2006-06 PHASE1
NCT00187447 COMPLETED
Patent Ductus Arteriosus
University of California, San Francisco
 2003-08 PHASE2
NCT00149149 COMPLETED
Healthy
Imperial College London
 2005-05-01 PHASE1
NCT00116623 TERMINATED
Labor, Premature
University of Pennsylvania
 2003-02 PHASE4
NCT00142558 COMPLETED
Acute Gout
Organon and Co
 2005-01-01 PHASE4
NCT00002796 TERMINATED
Mucinous Adenocarcinoma of the Colon; Mucinous Adenocarcinoma of the Rectum; Recurrent Colon Cancer; Recurrent Rectal Cancer; Signet Ring Adenocarcinoma of the Colon; Signet Ring Adenocarcinoma of the Rectum; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer
National Cancer Institute (NCI)
 1997-05 PHASE1; PHASE2
NCT02183168 COMPLETED
Spondylitis, Ankylosing
Boehringer Ingelheim
 2001-07-01 PHASE3
NCT01073670 COMPLETED
Hemorrhage
Queen's University
 2000-08 PHASE4
NCT02183155 COMPLETED
Healthy
Boehringer Ingelheim
 2000-05 PHASE4
NCT00009646 COMPLETED
Infant, Very Low Birth Weight; Infant, Premature; Ductus Arteriosus, Patent
NICHD Neonatal Research Network
 1993-11 PHASE3
NCT00000494 COMPLETED
Cardiovascular Diseases; Defect, Congenital Heart; Ductus Arteriosus, Patent; Heart Diseases
National Heart, Lung, and Blood Institute (NHLBI)
 1978-09 PHASE3
NCT00275730 COMPLETED
Ocular Physiology; Regional Blood Flow
Medical University of Vienna
 2006-01
NCT00473980 COMPLETED
Colorectal Cancer
Göteborg University
 1998-12 PHASE4
NCT00554476 TERMINATED
Lateral Epicondylitis
Azad University of Medical Sciences
 2003-01 PHASE4
NCT00170781 COMPLETED
Acute Gouty Arthritis
Novartis
 2005-06 PHASE4
NCT00002535 COMPLETED
Melanoma (Skin)
St. Luke's Medical Center
 1993-07 PHASE2
NCT00432081 COMPLETED
Alzheimer Disease
Radboud University Medical Center
 2000-05 PHASE3
NCT00485160 COMPLETED
Patent Ductus Arteriosus
Shaare Zedek Medical Center
 2002-02 PHASE3
NCT00239512 TERMINATED
Ductus Arteriosus, Patent; Preterm Infants
China Medical University Hospital
 2005-03
NCT00347035 TERMINATED
Glaucoma
Federal University of São Paulo
 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-06-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indomethacin acts as a nonselective inhibitor of cyclooxygenase-1 (COX1) and cyclooxygenase-2 (COX2), binding these enzyme active sites to prevent the conversion of arachidonic acid into pro-inflammatory prostaglandins. This enzymatic blockade suppresses downstream inflammatory signaling cascades and fever responses, providing clinical efficacy in reducing swelling and preventing complications such as post-ERCP pancreatitis.

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.