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Acetoxymethyl Benzylpenicillanate (PENAMECILLIN)

Phase 2 active Small molecule

Acetoxymethyl Benzylpenicillanate (generic name: PENAMECILLIN) is a penamecillin drug. It is currently in Phase 2 development.

Penamecillin works by inhibiting the synthesis of the bacterial cell wall, ultimately leading to bacterial cell death.

Penamecillin, also known as Acetoxymethyl Benzylpenicillanate, is a small molecule antibiotic belonging to the penicillin class. Its mechanism of action involves inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death. However, due to limited available information, its target, approved indications, pharmacokinetic properties, and commercial status remain unknown. Further research is necessary to fully understand its clinical applications and safety profile. As a result, it is not possible to provide a comprehensive summary of its use in clinical practice.

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 namePENAMECILLIN
Drug classpenamecillin
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhasePhase 2

Mechanism of action

Imagine the bacterial cell wall as a strong, protective shield. Penamecillin disrupts the process of building this shield, causing the bacterial cell to weaken and eventually die. This is a crucial step in treating bacterial infections.

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:

Frequently asked questions about Acetoxymethyl Benzylpenicillanate

What is Acetoxymethyl Benzylpenicillanate?

Acetoxymethyl Benzylpenicillanate (PENAMECILLIN) is a penamecillin drug.

How does Acetoxymethyl Benzylpenicillanate work?

Penamecillin works by inhibiting the synthesis of the bacterial cell wall, ultimately leading to bacterial cell death.

What is the generic name of Acetoxymethyl Benzylpenicillanate?

PENAMECILLIN is the generic (nonproprietary) name of Acetoxymethyl Benzylpenicillanate.

What drug class is Acetoxymethyl Benzylpenicillanate in?

Acetoxymethyl Benzylpenicillanate belongs to the penamecillin class. See all penamecillin drugs at /class/penamecillin.

What development phase is Acetoxymethyl Benzylpenicillanate in?

Acetoxymethyl Benzylpenicillanate is in Phase 2.

Related

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