Last reviewed 2026-05-28 · How we verify

Bactofen (BENZOXONIUM CHLORIDE)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 24/100

Bactofen (generic name: BENZOXONIUM CHLORIDE) is a benzoxonium chloride drug. It is currently in Phase 2 development.

Bactofen works by disrupting bacterial cell membranes, ultimately leading to cell death.

Bactofen is a medication that has been studied in clinical trials for ocular imaging, specifically using the slit lamp model SL-D-301 and the digital camera attachment DC-4. The exact mechanism of action and indications for Bactofen are not specified in the provided information, but it has been used in a completed clinical trial for ocular imaging.

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	BENZOXONIUM CHLORIDE
Drug class	benzoxonium chloride
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine a strong detergent that breaks down the protective layer around bacteria, causing them to die. This is essentially how Bactofen works, but instead of a detergent, it's a small molecule that interacts with the bacterial cell membrane. By disrupting this membrane, Bactofen prevents bacteria from functioning properly and ultimately kills them.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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:

Bactofen CI brief — competitive landscape report
Bactofen updates RSS · CI watch RSS

Frequently asked questions about Bactofen

What is Bactofen?

Bactofen (BENZOXONIUM CHLORIDE) is a benzoxonium chloride drug.

How does Bactofen work?

Bactofen works by disrupting bacterial cell membranes, ultimately leading to cell death.

What is the generic name of Bactofen?

BENZOXONIUM CHLORIDE is the generic (nonproprietary) name of Bactofen.

What drug class is Bactofen in?

Bactofen belongs to the benzoxonium chloride class. See all benzoxonium chloride drugs at /class/benzoxonium-chloride.

What development phase is Bactofen in?

Bactofen is in Phase 2.

Drug class: All benzoxonium chloride drugs
Therapeutic area: All drugs in Infectious Disease

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