Last reviewed 2026-04-19 · How we verify

APALCILLIN

Phase 2 active Small molecule

APALCILLIN is a apalcillin drug. It is currently in Phase 2 development.

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

Apalcillin is a small molecule antibiotic in the apalcillin class, but its original developer and current owner are unknown. It has a half-life of 1.2 hours, but its bioavailability and FDA approval status are not specified. Apalcillin's target and approved indications are also unknown. Its commercial status is unclear, but it is not listed as off-patent. Further research is needed to determine its safety and efficacy.

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	APALCILLIN
Drug class	apalcillin
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. Apalcillin stops the construction workers from building new walls, which eventually causes the building to collapse and die. This is how apalcillin 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:

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

Frequently asked questions about APALCILLIN

What is APALCILLIN?

APALCILLIN is a apalcillin drug.

How does APALCILLIN work?

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

What drug class is APALCILLIN in?

APALCILLIN belongs to the apalcillin class. See all apalcillin drugs at /class/apalcillin.

What development phase is APALCILLIN in?

APALCILLIN is in Phase 2.

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

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