Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 evaluate neomycin sulfate across diverse indications, including intestinal decolonization of multidrug-resistant bacteria, bacterial conjunctivitis, pediatric bowel preparation, contact dermatitis diagnostic testing, and virus-related neoplasms using gene marking. Sponsored by academic and health institutions such as Mahidol University, McMaster University, and Baylor College of Medicine, these studies encompass completed, recruiting, and terminated recruitment statuses. Together, they highlight the drug's role as a therapeutic antibacterial agent, an oral bowel preparation component, and a diagnostic tool.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07549828 NOT_YET_RECRUITING
Acne; Atopic Dermatitis; Seborrheic Dermatitis; Psoriasis; Healthy Subjects (HS)
National Taiwan University Hospital
 2026-04-01
NCT06747611 RECRUITING
Alopecia Areata; Alopecia Totalis; Alopecia Universalis
University of Minnesota
 2025-08-21 PHASE2
NCT07180615 NOT_YET_RECRUITING
Surgical Site Infection; Colon Surgery; Surgical Site Infections
Universität Luzern
 2026-06-01 PHASE4
NCT04729322 ACTIVE_NOT_RECRUITING
Metastatic Colorectal Adenocarcinoma; Metastatic Small Intestinal Adenocarcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IV Small Intestinal Adenocarcinoma AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8
M.D. Anderson Cancer Center
 2021-02-22 PHASE2
NCT06148025 RECRUITING
Vaccine Response Impaired
South Australian Health and Medical Research Institute
 2023-11-23 PHASE4
NCT07490054 RECRUITING
Chronic Heart Failure
Melana Yuzefpolskaya, MD
 2025-09-01 PHASE1
NCT03663504 ACTIVE_NOT_RECRUITING
Elective Colon Surgery
Ottawa Hospital Research Institute
 2018-10-23 PHASE4
NCT07698938 COMPLETED
Teste the Safety of (Polymyxin B Sulfate 500,000 IU, Bacitracin Zinc 40,000 IU, Neomycin Sulfate 0.35g Neomycin Base) Intranasally
Hospital Universitario Dr. Jose E. Gonzalez
 2025-02-13
NCT03593252 UNKNOWN
Colostomy; Hirschsprung Disease - Pull Through; Necrotizing Enterocolitis; Inflammatory Bowel Diseases; Meconium Ileus; Bowel Obstruction; Elective Surgery
McMaster University
 2022-01-01
NCT05593601 UNKNOWN
Colonization, Asymptomatic
Mahidol University
 2022-11-24 PHASE4
NCT05874219 COMPLETED
Hemodialysis Complication; Hemodialysis Catheter Infection
Future University in Egypt
 2023-04-10 PHASE2; PHASE3
NCT05999955 COMPLETED
Rhinosinusitis; Rhinitis
Huro Biotech Joint Stock Company
 2022-12-29
NCT03856671 COMPLETED
Surgical Site Infection; Postoperative Complications; Bowel Preparation; Oral Antibiotics; Colorectal Cancer
Third Affiliated Hospital, Sun Yat-Sen University
 2019-01-17
NCT05593601 Recruiting
Colonization Asymptomatic
Mahidol University
 2022-11-24 Phase 4
NCT03557008 COMPLETED
Rabies Human
Emory University
 2018-07-05 PHASE4
NCT03476317 COMPLETED
Crohn Disease
Children's Hospital of Philadelphia
 2018-07-12 PHASE2
NCT03042091 UNKNOWN
Colorectal Neoplasms; Diverticulitis; Inflammatory Bowel Diseases; Surgical Site Infection
Thomas Jefferson University
 2016-09 EARLY_PHASE1
NCT02765256 COMPLETED
Crohn's Disease
University of Pennsylvania
 2016-08 PHASE2
NCT02652637 UNKNOWN
Colorectal Surgery
Helsinki University Central Hospital
 2016-03 PHASE4
NCT02730962 TERMINATED
Pre-Diabetes
University of Minnesota
 2016-06 PHASE2
NCT02472600 UNKNOWN
Intestinal Colonization With Multidrug-resistant Bacteria
Stephen Harbarth
 2016-02 PHASE2
NCT02154061 COMPLETED
Influenza
Emory University
 2015-04
NCT02682485 WITHDRAWN
Anastomotic Leak; Rectal Cancer
University of Chicago
 2017-03-03 PHASE2
NCT01798537 UNKNOWN
Bacteremia Associated With Intravascular Line; Ventilator Associated Pneumonia; Bacteremia
Rambam Health Care Campus
 2013-06 PHASE2; PHASE3
NCT02344732 COMPLETED
Corneal Diseases
Universiti Sains Malaysia
 2013-10
NCT00062868 COMPLETED
Hodgkin Disease; Non Hodgkin Lymphoma; Lymphoepithelioma; Leiomyosarcoma
Baylor College of Medicine
 2003-09 PHASE1
NCT01638429 COMPLETED
Diabetes; Obesity
Cedars-Sinai Medical Center
 2012-04 EARLY_PHASE1
NCT02001909 COMPLETED
Neoplasms
Bayer
 2013-12 PHASE1
NCT00945334 COMPLETED
Constipation-predominant Irritable Bowel Syndrome
Mark Pimentel, MD
 2009-08
NCT00166868 COMPLETED
Biliary Atresia
National Taiwan University Hospital
 2003-12
NCT00058617 COMPLETED
Epstein-Barr Virus-Related Hodgkin Lymphoma; Epstein-Barr Virus-Related Non-Hodgkin Lymphoma; EBV Positive Plasma Cell Neoplasm
Baylor College of Medicine
 1996-01 PHASE1
NCT00857688 COMPLETED
Aphtous Ulcers
Azidus Brasil
 2011-05 PHASE3
NCT01227863 UNKNOWN
Bacterial Conjunctivitis; Acute
Azidus Brasil
 2011-02 PHASE3
NCT00997139 COMPLETED
Nasal Carriers of Staphylococcus Aureus
Northwestern University
 2009-09
NCT01097811 UNKNOWN
Hepatic Encephalopathy; Hypertension, Portal; Liver Cirrhosis
UPECLIN HC FM Botucatu Unesp
 2008-06
NCT02444481 COMPLETED
Vaginitis
Laboratoire Innotech International
 2009-04 PHASE4
NCT00355602 COMPLETED
Colitis, Ulcerative
University of Dundee
 2006-07
NCT00795951 Completed
Dermatitis Contact
Allerderm
 2008-11 Phase 4
NCT00058773 TERMINATED
Hodgkin Disease; Non-Hodgkins Lymphoma
Baylor College of Medicine
 1996-01 PHASE1
NCT00058617 Completed
Epstein-Barr Virus-Related Hodgkin Lymphoma|Epstein-Barr Virus-Related Non-Hodgkin Lymphoma|EBV Positive Plasma Cell Neoplasm
Baylor College of Medicine|The Methodist Hospital Research Institute|Center for Cell and Gene Therapy Baylor College of Medicine
 1996-01 Phase 1
NCT00534391 UNKNOWN
Hordeolum
Chulalongkorn University
 2007-09 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-04-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an aminoglycoside antibiotic, neomycin sulfate binds directly to the 16S rRNA component of the bacterial 30S ribosomal subunit, causing mistranslation and mRNA misreading during protein synthesis. This biochemical disruption leads to the accumulation of nonfunctional proteins and cellular envelope damage, ultimately driving bactericidal activity against susceptible Gram-positive and Gram-negative pathogens evaluated in clinical studies for conditions such as bacterial conjunctivitis and intestinal bacterial colonization.

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.