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Mycifradin

(Neomycin)

ApprovedSmall molecule

PPharmacia and Upjohn

Neomycin is an antibiotic used to treat bacterial infections, particularly ear and eye infections, and is also used to reduce bacteria in the intestines before surgery or to help treat certain liver conditions.[2] Mycifradin is currently approved and in use across 14 indications[4].[1]

Mycifradin is one of 292 small molecule programs targeting Bacterial Disease. It is currently in Approved.

14

Indications

22

Total Trials

4

Active Trials

291

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Bacterial DiseaseActive, not recruiting

PneumoniaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Prediabetes SyndromeApproved

EncephalopathyActive, not recruiting

Eye InfectionActive, not recruiting

Biliary AtresiaActive, not recruiting

OsteomyelitisApproved

Rectum CancerApproved

Ulcerative ColitisActive, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

PneumoniaPreclinical

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Prediabetes SyndromeApproved

Approved

EncephalopathyPreclinical

Active, not recruiting

Eye InfectionApproved

Active, not recruiting

Biliary AtresiaPreclinical

Active, not recruiting

OsteomyelitisApproved

Approved

Rectum CancerApproved

Approved

Ulcerative ColitisPreclinical

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

152 competitors in Pneumonia

#DrugCompanyPhaseTrials

Mycifradin

PPharmacia and Upjohn

Primaquine

Innohep

Jazz Pharmaceuticals

Plaquenil

Jazz Pharmaceuticals

Acanya

Avlosulfon

AAlmirall, S.A.

Zantac 150

Cancidas

FFresenius Kabi Taiwan Ltd.

Pepcid

Aciphex

Akero Therapeutics

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 1Recruiting

Chronic Heart Failure

NCT07490054

Phase 2Active, not recruiting

Metastatic Colorectal Cancer

NCT04729322

Q4 2028

ApprovedRecruiting

Vaccine Response Impaired

NCT06148025

Q2 2029

Post-ApprovalNot yet recruiting

Colon Surgery

NCT07180615

Clinical

Trials by Indication[1]

Antibiotics3 trials

Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics

Completed·EEmory University·N/A·NCT02154061·33 enrolled

Responses to Rabies Vaccine in Adults With or Without Antibiotics

Completed·EEmory University·Phase 4·NCT03557008·37 enrolled

Do Topical Antibiotics Improve Skin Graft Results?

Completed·LLAMB Project··NCT07286851·142 enrolled

Colorectal Surgery2 trials

Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery

Unknown status·TThomas Jefferson University·Phase 1·NCT03042091·224 enrolled

Bowel Preparation in Elective Pediatric Colorectal Surgery

Unknown status·MMcMaster University·N/A·NCT03593252·81 enrolled

Crohn's Disease2 trials

Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Completed·—·Phase 2·NCT03476317·10 enrolled

Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Completed·UUniversity of Pennsylvania·Phase 2·NCT02765256·8 enrolled

Complication1 trial

SURGIcal COmplication and MIcrobiome ChangeS in Colorectal Surgery

Unknown status·—··NCT05779254·100 enrolled

Colon Surgery1 trial

Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery

Not yet recruiting·—·Phase 4·NCT07180615·458 enrolled

13 more indications

Ulcerative Colitis1 trial

Antibiotics for the Treatment of Ulcerative Colitis

Completed·UUniversity of Dundee·N/A·NCT00355602·40 enrolled

Colonization1 trial

Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin

Unknown status·MMahidol University·Phase 4·NCT05593601·60 enrolled

Pneumonia1 trial

Efficacy of Intestinal Decontamination in Patients Colonized by Carbapenem-resistant Klebsiella Pneumoniae and Colistin

Completed·MMaimónides Biomedical Research Institute of Córdoba··NCT02604849·44 enrolled

Antibiotic-resistant Bacteria1 trial

Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy

Unknown status·SStephen Harbarth·Phase 2·NCT02472600·39 enrolled

Encephalopathy1 trial

Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

Unknown status·UUPECLIN HC FM Botucatu Unesp·N/A·NCT01097811·20 enrolled

Irritable Bowel Syndrome1 trial

Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome

Completed·MMark Pimentel, MD·N/A·NCT00945334·37 enrolled

Tics1 trial

Effect of Neomycin on the Pharmacokinetics of Regorafenib

Completed· Bayer logo

Bayer·Phase 1·NCT02001909·27 enrolled

Metastatic Colorectal Cancer1 trial

Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04729322·15 enrolled

Biliary Atresia1 trial

Use of Probiotics to Prevent Cholangitis in Children With Biliary Atresia After the Kasai Portoenterostomy

Completed·NNational Taiwan University Hospital·N/A·NCT00166868·30 enrolled

Metabolic Syndrome1 trial

Interventional Bioremediation of Microbiota in Metabolic Syndrome

Terminated·UUniversity of Minnesota·Phase 2·NCT02730962·12 enrolled

Chronic Heart Failure1 trial

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure

Recruiting·MMelana Yuzefpolskaya, MD·Phase 1·NCT07490054·40 enrolled

Vaccine Response Impaired1 trial

A Human Experimental Medicine Study to Assess Whether the Gut Microbiota Regulates Specific and Non-specific Immune Responses to Vaccination

Recruiting·SSouth Australian Health and Medical Research Institute·Approved·NCT06148025·348 enrolled

Unspecified1 trial

Role of Methane in Glycemic Control

Completed·—·Phase 1·NCT01638429·11 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

MYCIFRADIN

NDA NDA050285

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Neomycin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mycifradin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Neomycin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Neomycin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050285). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pharmacia and Upjohn company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPharmacia and Upjohn

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