Last reviewed 2026-06-02 · How we verify

Azidamphenicol (AZIDAMFENICOL)

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

Azidamphenicol (generic name: AZIDAMFENICOL) is a azidamfenicol drug. It is currently in Phase 2 development.

Azidamfenicol works by binding to the 50S ribosomal subunit of bacteria, preventing the formation of peptide bonds and thereby inhibiting protein synthesis.

Azidamfenicol is a small molecule antibiotic. It is also known by several other names, including Posifenicol, Azidanfenicol, Azidoamfenicol, and Azidamfenicol.

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	AZIDAMFENICOL
Drug class	azidamfenicol
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like factories that make proteins to keep you healthy. Bacteria are like tiny factories that make proteins too, but they're bad for you. Azidamfenicol is like a special tool that blocks the bacteria's factories from making proteins, which ultimately kills them.

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:

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

Frequently asked questions about Azidamphenicol

What is Azidamphenicol?

Azidamphenicol (AZIDAMFENICOL) is a azidamfenicol drug.

How does Azidamphenicol work?

Azidamfenicol works by binding to the 50S ribosomal subunit of bacteria, preventing the formation of peptide bonds and thereby inhibiting protein synthesis.

What is the generic name of Azidamphenicol?

AZIDAMFENICOL is the generic (nonproprietary) name of Azidamphenicol.

What drug class is Azidamphenicol in?

Azidamphenicol belongs to the azidamfenicol class. See all azidamfenicol drugs at /class/azidamfenicol.

What development phase is Azidamphenicol in?

Azidamphenicol is in Phase 2.

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

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