Last reviewed 2026-05-26 · How we verify

SULBENICILLIN

Phase 2 active Small molecule ✓ Verified May 2026 Quality 29/100

SULBENICILLIN is a sulbenicillin drug. It is currently in Phase 2 development.

Sulbenicillin works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.

Sulbenicillin is a small molecule antibiotic. It is also known by various synonyms, including alpha-sulfobenzylpenicillin, D-(-)-sulbenicillin, sulbenicilina, and others.

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	SULBENICILLIN
Drug class	sulbenicillin
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like buildings, and bacteria are like construction workers. Sulbenicillin stops the construction workers from building new walls, which eventually causes the building to collapse and die. This is how sulbenicillin kills bacteria.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

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

Frequently asked questions about SULBENICILLIN

What is SULBENICILLIN?

SULBENICILLIN is a sulbenicillin drug.

How does SULBENICILLIN work?

Sulbenicillin works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.

What drug class is SULBENICILLIN in?

SULBENICILLIN belongs to the sulbenicillin class. See all sulbenicillin drugs at /class/sulbenicillin.

What development phase is SULBENICILLIN in?

SULBENICILLIN is in Phase 2.

Drug class: All sulbenicillin drugs
Therapeutic area: All drugs in Infectious Disease

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