Last reviewed 2026-04-20 · How we verify

Fedacilina (METAMPICILLIN)

Phase 2 active Small molecule

Fedacilina (generic name: METAMPICILLIN) is a metampicillin drug. It is currently in Phase 2 development.

Fedacilina works by inhibiting the bacterial enzyme transpeptidase, which is essential for bacterial cell wall synthesis.

Fedacilina (Metampicillin) is a small molecule antibiotic in the penicillin class. It is used to treat various bacterial infections, although its specific indications are not well-documented. The commercial status of Fedacilina is unclear, and it may be available as a generic or patented product. As a penicillin antibiotic, Fedacilina works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death. However, more information is needed to provide a comprehensive summary.

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	METAMPICILLIN
Drug class	metampicillin
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine the bacterial cell wall like a brick wall. Fedacilina blocks the enzyme that helps hold the bricks together, causing the wall to weaken and eventually collapse, ultimately killing the bacterial cell.

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:

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

Frequently asked questions about Fedacilina

What is Fedacilina?

Fedacilina (METAMPICILLIN) is a metampicillin drug.

How does Fedacilina work?

Fedacilina works by inhibiting the bacterial enzyme transpeptidase, which is essential for bacterial cell wall synthesis.

What is the generic name of Fedacilina?

METAMPICILLIN is the generic (nonproprietary) name of Fedacilina.

What drug class is Fedacilina in?

Fedacilina belongs to the metampicillin class. See all metampicillin drugs at /class/metampicillin.

What development phase is Fedacilina in?

Fedacilina is in Phase 2.

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

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