Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate gentamicin sulfate across diverse indications, including acute mesenteric ischemia, hereditary ichthyosis, peritoneal dialysis-related infections, acute cholangitis, and cutaneous leishmaniasis. Sponsored by academic medical centers, research organizations, and industry partners, these investigations encompass active recruiting, pending, completed, and terminated statuses. Specific studies include Phase 2 evaluations for ichthyosis and Phase 3 trials for acute mesenteric ischemia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05977400 NOT_YET_RECRUITING
Premature Birth; Antibiotics; Neurodevelopment
Sharp HealthCare
 2024-04 PHASE3
NCT07752849 RECRUITING
Cleft Palate; Unilateral Cleft Palate; Bilateral Cleft Palate; Complete Cleft Palat; Incompelet Cleft Palate
Al-Thawra Modern General Hospital
 2026-08-01
NCT06712641 RECRUITING
Sepsis
University Hospital, Akershus
 2026-04-23 PHASE4
NCT04876131 RECRUITING
Complicated Urinary Tract Infection; Infection; Pediatric Infectious Disease
Murdoch Childrens Research Institute
 2022-05-30 PHASE4
NCT05157126 RECRUITING
Fracture Open Tibia
University of California, San Francisco
 2022-09-01 PHASE4
NCT06814223 RECRUITING
Infection Catheter-Related
Western Galilee Hospital-Nahariya
 2024-10-28 PHASE4
NCT04805164 RECRUITING
Osteomyelitis Chronic
Hospices Civils de Lyon
 2021-10-14
NCT06387147 RECRUITING
Acute Mesenteric Ischemia
Assistance Publique - Hôpitaux de Paris
 2025-01-31 PHASE3
NCT07270380 RECRUITING
Osteomyelitis
Biocomposites Ltd
 2026-06
NCT07220967 RECRUITING
Breast Cancer
Memorial Sloan Kettering Cancer Center
 2025-10-21 PHASE4
NCT07643974 NOT_YET_RECRUITING
Spinal Cord Injury; Neurogenic Bladder (NB); Neurogenic Lower Urinary Tract Dysfunction; Multiple Sclerosis; Spina Bifida; Urinary Tract Infection(UTI)
Medstar Health Research Institute
 2026-08 EARLY_PHASE1
NCT06841003 NOT_YET_RECRUITING
Complicated Appendicitis; Intra-Abdominal Abscess
Spaarne Gasthuis
 2025-02 PHASE3
NCT07655050 RECRUITING
Kidney Calculi; Urolithiasis; Urinary Tract Infections
Hitit University
 2026-06-15
NCT07563504 NOT_YET_RECRUITING
Rupture of Membranes Prior to Onset of Labor
Sarawak General Hospital
 2026-07-01 PHASE4
NCT07311395 RECRUITING
Surgical Site Infection
Western Galilee Hospital-Nahariya
 2025-12-08
NCT05766670 RECRUITING
Open tíbia Fracture; Osteomyelitis Tibia; Tibial Fractures
Wake Forest University Health Sciences
 2024-04-08 PHASE3
NCT06332040 RECRUITING
Catheter Infection
St. Joseph's Hospital and Medical Center, Phoenix
 2023-10-09 PHASE4
NCT04731025 ACTIVE_NOT_RECRUITING
Implant Complication; Implant Infection; Implant Site Infection; Implant Capsular Contracture; Implant Site Pocket Infection; Implant Expulsion; Antibiotic Side Effect
Mikkel Herly
 2021-01-27 PHASE3
NCT07407491 RECRUITING
Acute Cholangitis; Biliary Tract Infection; Biliary Obstruction; Choledocholithiasis; Malignant Biliary Stricture
National University of Malaysia
 2024-07-09 PHASE2
NCT05595603 RECRUITING
Giant Cell Tumor of Bone
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2023-03 PHASE2
NCT06489431 ACTIVE_NOT_RECRUITING
Erectile Dysfunction; Penile Prosthesis; Complications, Infection or Inflammation
Rush University Medical Center
 2023-12-04 PHASE3
NCT06209047 RECRUITING
Bronchiectasis With Acute Exacerbation
Assiut University
 2023-10-15 PHASE4
NCT06362447 NOT_YET_RECRUITING
Ichthyosis
University Hospital, Toulouse
 2024-09 PHASE2
NCT05750966 COMPLETED
Cholangitis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2023-07-19
NCT07470112 ACTIVE_NOT_RECRUITING
Surgical Site Infection (SSI)
Zagazig University
 2025-05-20
NCT05164081 ACTIVE_NOT_RECRUITING
Femoral Neck Fractures; Prosthetic Infection
Umeå University
 2022-01-01 PHASE3
NCT07478874 COMPLETED
Surgical Site Infection (SSI)
Lahore General Hospital
 2025-07-01
NCT06007352 WITHDRAWN
Urinary Tract Infections; Sepsis
Yale University
 2024-10 PHASE2
NCT06332781 COMPLETED
Recurrent Uti
Women and Infants Hospital of Rhode Island
 2025-04-28 PHASE4
NCT05469984 RECRUITING
Preterm Labor With Preterm Delivery; Premature Rupture of Membranes Prolonged
Western Galilee Hospital-Nahariya
 2022-11-25
NCT03132116 COMPLETED
Cat-Scratch Disease
University Hospital, Toulouse
 2017-05-31 PHASE3
NCT05143164 COMPLETED
Peritoneal Dialysis Catheter Exit Site Infection
Singapore General Hospital
 2022-03-11
NCT06792864 ENROLLING_BY_INVITATION
Cranioplasty; Craniotomy; Craniotomy Clipping; Craniotomy Surgery; Craniocerebral Trauma; Craniocerebral Injuries
Universidad Austral de Chile
 2024-07-01 PHASE3
NCT06906354 COMPLETED
Bronchiectasis Adult; Bronchiectasis With Acute Exacerbation
Alexandria University
 2024-11-11
NCT02829060 COMPLETED
Nephrolithiasis; Urinary Tract Infection (UTI); Sepsis
University of California, San Diego
 2016-01
NCT02848820 UNKNOWN
Appendicitis
Ramon Gorter
 2016-12 PHASE4
NCT03845790 COMPLETED
Surgical Site Infection
Poitiers University Hospital
 2019-05-26 PHASE1
NCT06387147 Not yet recruiting
Acute Mesenteric Ischemia
Assistance Publique - Hôpitaux de Paris
 2024-09-01 Phase 3
NCT06143462 UNKNOWN
Vestibular Disorder
Eye & ENT Hospital of Fudan University
 2024-01-01
NCT05051163 UNKNOWN
HIV-1-infection; Malnutrition, Child
Makerere University
 2021-06-14 PHASE2; PHASE3
NCT06168708 UNKNOWN
Post-TURP Infectious Complications
Tanta University
 2023-12-07
NCT05303909 TERMINATED
Healthy Volunteers
Singapore General Hospital
 2022-05-11 PHASE2
NCT04110340 COMPLETED
Plague, Bubonic; Plague, Pneumonic
University of Oxford
 2020-02-15 PHASE3
NCT04041791 COMPLETED
Pneumonia
University of Oxford
 2019-08-19 PHASE3
NCT06362447 Not yet recruiting
Ichthyosis
University Hospital Toulouse
 2024-04-23 Phase 2
NCT04789928 COMPLETED
Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection
Institut Pasteur
 2021-01-05 PHASE1
NCT03392909 UNKNOWN
Recessive Dystrophic Epidermolysis Bullosa
University of Southern California
 2018-07-05 PHASE1; PHASE2
NCT05429671 COMPLETED
Total Knee Arthoplasty
Rothman Institute Orthopaedics
 2022-06-20 PHASE3
NCT04140786 UNKNOWN
Junctional Epidermolysis Bullosa
University of Southern California
 2019-10-31 PHASE1; PHASE2
NCT03503513 COMPLETED
Urinary Tract Infections; Spinal Cord Injuries; Spinal Cord Diseases; Neurogenic Bladder
University of Michigan
 2018-08-24 PHASE2; PHASE3
NCT05287425 COMPLETED
Nasal and Pharyngeal Microbiome
Medical University of Vienna
 2019-08-12 PHASE2
NCT05503147 UNKNOWN
Malnutrition; Anorexia; Cannabis; Aging; Emergency Service, Hospital; Renal Function; Pharmacokinetics
Ove Andersen
 2022-03-24 PHASE1
NCT05702762 UNKNOWN
Urinary Tract Infections
Mercy Health Ohio
 2022-10-01 PHASE2
NCT03838575 UNKNOWN
Surgical Site Infection; Surgical Wound Infection; Surgery--Complications; Surgery
University of Birmingham
 2019-03-01 PHASE3
NCT05251584 UNKNOWN
Peritoneal Dialysis-related Infection
Phramongkutklao College of Medicine and Hospital
 2021-12-01
NCT02701595 COMPLETED
Infective Endocarditis
University Hospital, Tours
 2016-02-29 PHASE3
NCT05593601 Recruiting
Colonization Asymptomatic
Mahidol University
 2022-11-24 Phase 4
NCT04544943 COMPLETED
Atopic Dermatitis
Hoth Therapeutics, Inc.
 2021-05-17 PHASE1
NCT05202158 UNKNOWN
Kidney Stone
Ankara Training and Research Hospital
 2022-02-15
NCT05355610 UNKNOWN
Vestibular Disorder Preservation
Combined Military Hospital Quetta
 2021-04-01
NCT05503147 Recruiting
Malnutrition|Anorexia|Cannabis|Aging|Emergency Service Hospital|Renal Function|Pharmacokinetics
Ove Andersen|University Hospital Bispebjerg and Frederiksberg|North Denmark Regional Hospital|University of Copenhagen|Region Hovedstadens Apotek|Glostrup University Hospital Copenhagen|Hvidovre University Hospital
 2022-03-24 Phase 1
NCT04644627 COMPLETED
Epidermolysis Bullosa
Oslo University Hospital
 2020-12-01 PHASE1; PHASE2
NCT03483363 TERMINATED
Surgical Site Infection
The University of Texas Health Science Center, Houston
 2018-10-09 PHASE4
NCT04246996 COMPLETED
Postoperative Urinary Tract Infection; Pelvic Organ Prolapse; Stress Urinary Incontinence
Kaiser Permanente
 2020-01-29 PHASE2
NCT05251584 Unknown status
Peritoneal Dialysis-related Infection
Phramongkutklao College of Medicine and Hospital|Silpakorn University
 2021-12-01 Not Applicable
NCT03559400 COMPLETED
Open Tibia Fracture
University of California, San Francisco
 2019-11-19
NCT04238923 UNKNOWN
Vascular Diseases; Peripheral Vascular Disease; Surgical Site Infection; Bypass Complication
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2020-05-01 PHASE2; PHASE3
NCT06454643 COMPLETED
Cardiac Infection
Al-Rasheed University College
 2020-01-01
NCT03476941 TERMINATED
Abdominal Abscess
University of Iowa
 2019-04-01 PHASE2
NCT02717871 COMPLETED
Keratitis; Infectious Disease (Manifestation)
University Hospital, Geneva
 2016-03 PHASE3
NCT02415257 WITHDRAWN
Vestibular Schwannoma
Lund University
 2015-04 PHASE4
NCT03526159 RECRUITING
Junctional Epidermolysis Bullosa
University of Southern California
 2018-06-01 PHASE1; PHASE2
NCT03931408 COMPLETED
Neurogenic Bladder; Spinal Cord Injuries
University of Louisville
 2019-02-19 PHASE2
NCT04505748 COMPLETED
Arthroplasty Complications; Total Knee Arthroplasty
University Hospital, Alexandroupolis
 2020-01-01
NCT03294395 COMPLETED
Gonorrhea
Public Health Service of Amsterdam
 2017-09-18 PHASE3
NCT04332809 UNKNOWN
Appendicitis
Mansoura University
 2019-01-01
NCT02865564 COMPLETED
Gastrointestinal Diseases; Colic
University Medical Centre Ljubljana
 2016-11
NCT03560232 TERMINATED
Open Fracture; Post-Op Wound Infection
Mercy Health Ohio
 2018-07-09 PHASE4
NCT03174236 UNKNOWN
Malnutrition Severe; Antibiotic Resistance; Antibiotic Toxicity
University of Oxford
 2017-09-04 PHASE3
NCT03778008 UNKNOWN
Stomatitis
Second Affiliated Hospital of Nanchang University
 2018-12-21 PHASE2
NCT04967859 COMPLETED
Hemodialysis Catheter Infection
Universidade Estadual Paulista Júlio de Mesquita Filho
 2018-07-01 PHASE1
NCT03369093 COMPLETED
Treatment Failure; Lethargy; Altered Mental Status; Convulsion, Non-Epileptic; Hypoxia; Feeding; Difficult, Newborn
International Centre for Diarrhoeal Disease Research, Bangladesh
 2018-01-01
NCT02582099 UNKNOWN
Rhinosinusitis
Mahidol University
 2017-01-01 PHASE4
NCT02477423 COMPLETED
Premature Birth of Newborn; Enterocolitis, Necrotizing
University of Chicago
 2015-07
NCT02379754 WITHDRAWN
Vestibular Schwannoma
Lund University
 2015-01 PHASE4
NCT03632109 TERMINATED
Pharyngeal Gonococcal Infection
University of Washington
 2018-09-17 PHASE2; PHASE3
NCT03492866 UNKNOWN
Hereditary Hypotrichosis Simplex
Tel-Aviv Sourasky Medical Center
 2018-04 PHASE2
NCT03213249 COMPLETED
Breast Implant Infection; Mammoplasty
Washington University School of Medicine
 2017-07-25 PHASE1
NCT03299387 WITHDRAWN
Urinary Tract Infections
Mayo Clinic
 2017-06-28 PHASE4
NCT03638310 COMPLETED
Vestibular Schwannoma; Vestibular Function Disorder
Charles University, Czech Republic
 2016-01-01
NCT03012191 COMPLETED
Recessive Dystrophic Epidermolysis Bullosa
University of Southern California
 2017-02-02 PHASE1; PHASE2
NCT02579161 COMPLETED
Kidney Stones
Northwell Health
 2014-09 PHASE3
NCT02926846 COMPLETED
Peritonitis; Kidney Failure
Alice Ho Miu Ling Nethersole Hospital
 2014-03 PHASE4
NCT02947737 COMPLETED
Burns
Emory University
 2017-02-01
NCT02735317 UNKNOWN
Nasopharyngeal Neoplasms; Stomatitis
Yun-fei Xia
 2016-04 PHASE2
NCT02698735 COMPLETED
Recessive Dystrophic Epidermolysis Bullosa
University of Southern California
 2016-02-25 PHASE1; PHASE2
NCT02384200 COMPLETED
Nephrolithiasis; Urinary Tract Infections
University of California, San Diego
 2015-03 PHASE4
NCT01994993 COMPLETED
Complicated Intra Abdominal Infections
Michael Cohen-Wolkowiez
 2013-12 PHASE2; PHASE3
NCT02898961 COMPLETED
Sepsis
Centre Hospitalier Universitaire de Nīmes
 2014-10 PHASE4
NCT02515448 COMPLETED
Ventilator-associated Pneumonia
Poitiers University Hospital
 2015-10 PHASE1
NCT02427802 COMPLETED
Foot Ulcer, Diabetic; Infection
Innocoll
 2015-05 PHASE3
NCT02447172 COMPLETED
Foot Ulcer, Diabetic; Infection
Innocoll
 2015-06 PHASE3
NCT01951768 COMPLETED
Diabetic Foot Ulcer
University Hospital, Geneva
 2013-09 PHASE4
NCT01790659 COMPLETED
Cutaneous Leishmaniasis
U.S. Army Medical Research and Development Command
 2013-05 PHASE3
NCT01982864 TERMINATED
Renal Failure Chronic Requiring Hemodialysis
University Hospital, Limoges
 2013-10 PHASE4
NCT01988909 COMPLETED
Cutaneous Leishmaniasis
Assistance Publique - Hôpitaux de Paris
 2013-09 PHASE2
NCT02963896 COMPLETED
Vestibular Schwannoma
University Hospital, Motol
 2014-01
NCT01884467 UNKNOWN
Urinary Tract Infections
Gillette Children's Specialty Healthcare
 2013-05 PHASE4
NCT01659866 COMPLETED
Infection
Northwestern University
 2012-08 PHASE4
NCT02479971 COMPLETED
Pain
Hospital General Universitario Elche
 2014-01 PHASE3
NCT00802529 COMPLETED
Meniere's Disease
Imperial College London
 2009-04 PHASE2; PHASE3
NCT01570192 TERMINATED
Bacterial Pneumonia
University of Florida
 2010-09 PHASE2
NCT02399059 COMPLETED
Colorectal Tumors
Hospital General Universitario Elche
 2011-01 PHASE3
NCT01247909 COMPLETED
Infant Bacterial Meningitis
Kamuzu University of Health Sciences
 2010-04 PHASE4
NCT01551394 COMPLETED
Sepsis
PENTA Foundation
 2012-09 PHASE3
NCT02036528 TERMINATED
Diabetic Foot Ulcers
Royer Biomedical, Inc.
 2014-01 PHASE1; PHASE2
NCT02314806 COMPLETED
Breast Cancer
Hospital General Universitario Elche
 2013-01 PHASE3
NCT00751374 UNKNOWN
Rate of Exit Site Infection; Rate of Atypical Mycobacterial Infection; Rate of Peritoneal Dialysis
Kwong Wah Hospital
 2008-09 PHASE4
NCT01761487 UNKNOWN
Carriers of Carbapenem-resistant Klebsiella Pneumonia
Soroka University Medical Center
 2013-01 PHASE4
NCT01140191 TERMINATED
Leishmaniasis, Cutaneous
U.S. Army Medical Research and Development Command
 2013-09 PHASE2
NCT01785641 COMPLETED
Peritonitis
Chulalongkorn University
 2012-12
NCT01333982 COMPLETED
Sepsis
International Centre for Diarrhoeal Disease Research, Bangladesh
 2010-04
NCT01027429 COMPLETED
Neonatal Sepsis; Sepsis; Infection
Aga Khan University
 2009-12 PHASE3
NCT00844337 COMPLETED
Sepsis
Johns Hopkins Bloomberg School of Public Health
 2009-03
NCT00977405 TERMINATED
Superficial Surgical Site Infection
Singapore General Hospital
 2009-09 PHASE2
NCT01287780 COMPLETED
Surgical Wound Infection
Oslo University Hospital
 2011-01 PHASE3
NCT01633762 COMPLETED
Diabetes; Obesity; Osteoporosis; Inflammation
University Hospital, Gentofte, Copenhagen
 2012-04 EARLY_PHASE1
NCT01273818 COMPLETED
Inguinal Hernia
Diskapi Teaching and Research Hospital
 2011-01 PHASE4
NCT00926796 COMPLETED
Gonorrhoea
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-06 PHASE4
NCT01153191 UNKNOWN
Infections
Dallas VA Medical Center
 2010-08
NCT01700504 COMPLETED
Axillary Drainage Volume After Lymph Node Dissection.
Hospital General Universitario Elche
 2011-05 PHASE3
NCT01494350 TERMINATED
Cutaneous Leishmaniasis
U.S. Army Medical Research and Development Command
 2011-12 PHASE2
NCT00879190 COMPLETED
Chorioamnionitis
Stanford University
 2009-05 PHASE2; PHASE3
NCT01429701 COMPLETED
Eczema
EMS
 2012-05 PHASE3
NCT00814905 WITHDRAWN
Chorioamnionitis
United States Naval Medical Center, Portsmouth
 2008-11-18
NCT00638157 TERMINATED
Infective Endocarditis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2009-02-13 PHASE4
NCT01083576 COMPLETED
Leishmaniasis, Cutaneous
U.S. Army Medical Research and Development Command
 2010-03 PHASE2
NCT01032382 COMPLETED
Leishmaniasis, Cutaneous
U.S. Army Medical Research and Development Command
 2010-01 PHASE2
NCT01633294 COMPLETED
Chorioamnionitis; Puerperal Endometritis; Neonatal Early Onset Sepsis; Neonatal Meningitis; Neonatal Pneumonia
Hospital de Santa Maria, Portugal
 2008-10 PHASE2; PHASE3
NCT01378832 COMPLETED
Surgical Site Infection
Universidad Miguel Hernandez de Elche
 2010-01 PHASE3
NCT01148693 COMPLETED
Cholangitis
Tehran University of Medical Sciences
 2009-12
NCT00600483 COMPLETED
Cardiac Surgery; Sternal Wound Infection
Innocoll
 2007-12 PHASE3
NCT00753558 COMPLETED
Carriage of Carbapemen-resistant Klebsialle Pneumoniae
Soroka University Medical Center
 2008-11
NCT00671528 TERMINATED
Dermatitis, Atopic; Eczema, Atopic; Skin Diseases, Eczematous
Organon and Co
 2009-07 PHASE4
NCT00571259 COMPLETED
Bacteremia
Satellite Healthcare
 2003-09 PHASE4
NCT01678365 COMPLETED
Complicated Appendicitis
HaEmek Medical Center, Israel
 2008-07 PHASE4
NCT00658957 TERMINATED
Diabetic Foot Ulcer
Innocoll
 2008-04 PHASE2
NCT00749866 COMPLETED
Bronchiectasis
University of Edinburgh
 2007-05 PHASE4
NCT00451074 COMPLETED
Duchenne Muscular Dystrophy
Nationwide Children's Hospital
 2007-03 PHASE1
NCT00659646 COMPLETED
Diabetic Foot Ulcer
Innocoll
 2008-04 PHASE2
NCT00593567 COMPLETED
Diabetic Foot Ulcer
Innocoll
 2007-12 PHASE2
NCT00600925 COMPLETED
Colorectal Surgery; Surgical Wound Infection
Innocoll
 2008-01 PHASE3
NCT00484055 COMPLETED
Drug Resistance, Bacterial; Postoperative Wound Infection
Region Örebro County
 2007-01
NCT01244256 SUSPENDED
Folliculitis
Azidus Brasil
 2007-04 PHASE2; PHASE3
NCT00657917 TERMINATED
Cutaneous Leishmaniasis
U.S. Army Medical Research and Development Command
 2006-12-20 PHASE2
NCT00490230 COMPLETED
Cutaneous Leishmaniasis; Scar
U.S. Army Medical Research and Development Command
 2007-04
NCT01536795 COMPLETED
Old World Cutaneous Leishmaniasis
U.S. Army Medical Research and Development Command
 2005-10 PHASE2
NCT00304811 COMPLETED
Staphylococcus Aureus
Michael E. DeBakey VA Medical Center
 2006-01 PHASE4
NCT00185991 COMPLETED
Chorioamnionitis
Stanford University
 2004-06
NCT00198601 COMPLETED
Infection
Johns Hopkins Bloomberg School of Public Health
 2003-08 PHASE4
NCT01878643 COMPLETED
Respiratory Infection; Bacterial Resistance; Respiratory Failure
Stony Brook University
 2001-12 EARLY_PHASE1
NCT00396578 COMPLETED
Ventilator Associated Pneumonia; Respiratory Infection; Tracheobronchitis
Stony Brook University
 2003-08 PHASE2
NCT00189384 UNKNOWN
Bacterial Infection; Sepsis; Infant, Newborn
Aga Khan University
 2003-11 PHASE3
NCT00128466 COMPLETED
Plague
Centers for Disease Control and Prevention
 2004-08 PHASE2; PHASE3
NCT00480376 UNKNOWN
Infection
HaEmek Medical Center, Israel
 2007-06 PHASE4
NCT00376428 TERMINATED
Cystic Fibrosis
Assistance Publique - Hôpitaux de Paris
 2003-01 PHASE2
NCT00005574 COMPLETED
Becker Muscular Dystrophy; Duchenne Muscular Dystrophy
National Institute of Neurological Disorders and Stroke (NINDS)
 2000-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2023-08-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gentamicin sulfate irreversibly binds to the bacterial 30S ribosomal subunit, inducing codon misreading and inhibiting functional protein synthesis. This translation disruption compromises bacterial cellular integrity and leads to bactericidal cell death, suppressing bacterial proliferation in clinical conditions such as acute cholangitis and peritoneal dialysis-related infections.

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.