PeptideTrace
ApprovedPolymyxin Antibiotic

Polymyxin B

Poly-Rx, Neosporin (combination), Cortisporin (combination)

A

Evidence Grade A — Regulatory approved. 7061 published studies. 66 registered clinical trials.

66 trials7,061 studiesUSEUCA

Licensed Indications

  • Minor Wound Infection Prevention

User Experience Reports

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Overview

Polymyxin B is a close relative of colistin, used as a last-resort intravenous antibiotic for gram-negative infections resistant to virtually all other drugs. Outside of critical care, most people encounter polymyxin B as an ingredient in over-the-counter antibiotic creams like Neosporin and eye drops like Polytrim — where the tiny amounts applied topically pose no systemic toxicity concerns.

Research Activity

7,061studies
Human 3098
Animal 1729
In-vitro 1289
Reviews 302

7,061 published studies: 3098 human, 1729 animal, 1289 in-vitro, 302 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CAPrescription drug

Summary

Polymyxin B is marketed as Poly-Rx (injection, approved approximately 1964) and is a component of numerous topical products including Neosporin, Cortisporin, and Polytrim. Intravenous polymyxin B and colistin are generally considered interchangeable for systemic infections.

Recent international consensus guidelines recommend targeting specific blood level thresholds for intravenous polymyxin B. Kidney injury rates are comparable to colistin (approximately 40–45%), but polymyxin B may cause more neurotoxicity (all reversible). Outside of critical care, the vast majority of polymyxin B use is in over-the-counter topical antibiotic combinations for minor skin wounds and eye infections, where systemic toxicity is not a concern.

Mechanism of Action

Polymyxin B works through the same fundamental mechanism as colistin — binding to lipid A on the gram-negative bacterial outer membrane, disrupting membrane integrity, and causing cell death. The key pharmacological difference is that polymyxin B is given in its active form, while colistin is given as an inactive prodrug that must be converted in the body. This means polymyxin B reaches effective concentrations more rapidly and predictably, which matters in critically ill patients.

Research Summary

Like colistin, polymyxin B was approved decades before modern trial standards, so its evidence base consists largely of observational data from critically ill patients. Kidney injury occurs in approximately 40-45% of patients receiving intravenous polymyxin B — comparable to colistin — though it may cause more neurological side effects. The pharmacological advantage over colistin is that polymyxin B is administered in its active form, reaching effective blood levels more rapidly and predictably. Colistin is given as an inactive prodrug that must be converted in the body, introducing variability. For critically ill patients, this predictability matters. International guidelines now recommend specific blood level targets for intravenous polymyxin B. No large randomised trials have compared it against newer antibiotics.

Clinical Trials

NCT04352985N/AUnknown

Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19

Spectral Diagnostics (US) Inc.
NCT00000635N/ACompleted

Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine

National Institute of Allergy and Infectious Diseases (NIAID)Completion: 1992-04-01
NCT02825329N/AUnknown

Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock

Spectral Diagnostics (US) Inc.
NCT07431307Phase IINot Yet Recruiting

Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex

BioVersys AGEndpoint: The incidence of treatment-related treatment emergent adverse events (TRTEAEs) in the Safety population, assessed through End of Study (EoS) visit in Part A and Part B.Completion: 2028-07-01
NCT07502144Phase INot Yet Recruiting

A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers

Venus Remedies LimitedEndpoint: Geometric Mean of Fold Changes From Baseline in Six Urinary Kidney Injury Biomarkers (CLU, CysC, KIM-1, NAG, NGAL, OPN), Each Normalized to Urine Creatinine (Composite Measure)Completion: 2026-12-01
View all 66 trials on ClinicalTrials.gov →

Regulatory Timeline

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Related Compounds

Corticotropin

Approved
Repository ACTH Preparation

Corticotropin is marketed as H.P. Acthar Gel (currently ANI Pharmaceuticals). It carries approximately 19 FDA-labelled indications including infantile spasms (its strongest evidence base), nephrotic syndrome, multiple sclerosis relapses, and rheumatic disorders. Acthar Gel has been at the centre of major pricing and legal controversies. The price rose from approximately $40 per vial in 2001 to over $40,000, driven by successive acquisitions and orphan-like positioning despite broad labelling. The former manufacturer Mallinckrodt agreed to a $260 million settlement over antitrust concerns. Clinically, the strongest evidence supports its use in infantile spasms, where it is considered a first-line treatment. For most other indications, debate continues over whether it offers meaningful advantages over far less expensive oral corticosteroids.

Enfuvirtide

Approved
HIV Fusion Inhibitor (Peptide)

Enfuvirtide is marketed as Fuzeon (approved March 2003). It requires twice-daily subcutaneous injections, and injection-site reactions occur in nearly all patients (98%). In clinical trials (TORO-1 and TORO-2), enfuvirtide combined with an optimised background regimen achieved significantly greater viral suppression than background regimen alone in treatment-experienced patients. Enfuvirtide represented a major advance when HIV drug resistance was a more pressing clinical challenge, but its use has declined substantially with the arrival of more convenient oral antiretrovirals. The twice-daily injection burden, injection-site reactions, high cost, and complex manufacturing (it is one of the largest synthetic peptides manufactured at scale) have limited its role to a last-resort option for patients with highly resistant HIV.

Vancomycin

Approved
Glycopeptide Antibiotic

Vancomycin is marketed as Vancocin and Firvanq (approved 1958, with oral solution Firvanq approved 2018). It is the standard treatment for serious MRSA infections (bloodstream infections, endocarditis, pneumonia, bone infections) and is first-line for severe C. difficile colitis. Vancomycin requires therapeutic drug monitoring — blood levels must be checked regularly to ensure the dose is effective without causing kidney damage or hearing loss. The rise of vancomycin-resistant enterococci (VRE) and occasional vancomycin-intermediate S. aureus (VISA) strains represent ongoing challenges. Despite being nearly 70 years old, vancomycin remains irreplaceable for many serious infections, though newer alternatives like daptomycin and the lipoglycopeptides offer advantages in specific settings.