Last reviewed 2026-05-28 · How we verify

polymixin/bacitracin

Vanderbilt University Medical Center · Phase 3 active Small molecule Under review Quality 0/100

polymixin/bacitracin is a Polymyxin antibiotic Small molecule drug developed by Vanderbilt University Medical Center. It is currently in Phase 3 development for Treatment of infections caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Klebsiella-Enterobacter species..

Polymyxin B and bacitracin work together to inhibit bacterial cell wall synthesis and disrupt bacterial cell membranes.

Polymixin/bacitracin is a topical antibiotic used to treat various conditions, including blood stream infections and skin diseases, as well as prevent central line infections in intensive care units. It works by inhibiting C55-isoprenyl pyrophosphate, a protein involved in bacterial cell wall synthesis.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	polymixin/bacitracin
Sponsor	Vanderbilt University Medical Center
Drug class	Polymyxin antibiotic
Modality	Small molecule
Therapeutic area	Infectious disease
Phase	Phase 3

Mechanism of action

Polymyxin B binds to the bacterial cell membrane, causing a disruption in the cell membrane's structure and function. Bacitracin inhibits the synthesis of the bacterial cell wall by inhibiting the enzyme responsible for the formation of the cell wall. This combination of actions results in the death of the bacterial cell.

Approved indications

Treatment of infections caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Klebsiella-Enterobacter species.

Common side effects

Nephrotoxicity
Ototoxicity
Neuromuscular blockade

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

polymixin/bacitracin CI brief — competitive landscape report
polymixin/bacitracin updates RSS · CI watch RSS
Vanderbilt University Medical Center portfolio CI

Frequently asked questions about polymixin/bacitracin

What is polymixin/bacitracin?

polymixin/bacitracin is a Polymyxin antibiotic drug developed by Vanderbilt University Medical Center, indicated for Treatment of infections caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Klebsiella-Enterobacter species..

How does polymixin/bacitracin work?

Polymyxin B and bacitracin work together to inhibit bacterial cell wall synthesis and disrupt bacterial cell membranes.

What is polymixin/bacitracin used for?

polymixin/bacitracin is indicated for Treatment of infections caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Klebsiella-Enterobacter species..

Who makes polymixin/bacitracin?

polymixin/bacitracin is developed by Vanderbilt University Medical Center (see full Vanderbilt University Medical Center pipeline at /company/vanderbilt-university-medical-center).

What drug class is polymixin/bacitracin in?

polymixin/bacitracin belongs to the Polymyxin antibiotic class. See all Polymyxin antibiotic drugs at /class/polymyxin-antibiotic.

What development phase is polymixin/bacitracin in?

polymixin/bacitracin is in Phase 3.

What are the side effects of polymixin/bacitracin?

Common side effects of polymixin/bacitracin include Nephrotoxicity, Ototoxicity, Neuromuscular blockade.

Drug class: All Polymyxin antibiotic drugs
Manufacturer: Vanderbilt University Medical Center — full pipeline
Therapeutic area: All drugs in Infectious disease
Indication: Drugs for Treatment of infections caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Klebsiella-Enterobacter species.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing