Last reviewed 2026-06-03 · How we verify

Azidobenzylpenicillin (AZIDOCILLIN)

Phase 2 active Small molecule ✓ Verified Jun 2026

Azidobenzylpenicillin (generic name: AZIDOCILLIN) is a azidocillin drug. It is currently in Phase 2 development for Respiratory tract infection.

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

Azidobenzylpenicillin is a small molecule antibiotic. It is also known by various synonyms, including Azidocilina, Azidocillin, and BRL 2534.

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	AZIDOCILLIN
Drug class	azidocillin
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine the bacterial cell wall as a strong, protective shield. Azidocillin blocks the enzymes that help build this shield, causing the bacteria to weaken and eventually die. This allows the body's immune system to fight off the infection more effectively.

Approved indications

Respiratory tract infection

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:

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

Frequently asked questions about Azidobenzylpenicillin

What is Azidobenzylpenicillin?

Azidobenzylpenicillin (AZIDOCILLIN) is a azidocillin drug, indicated for Respiratory tract infection.

How does Azidobenzylpenicillin work?

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

What is Azidobenzylpenicillin used for?

Azidobenzylpenicillin is indicated for Respiratory tract infection.

What is the generic name of Azidobenzylpenicillin?

AZIDOCILLIN is the generic (nonproprietary) name of Azidobenzylpenicillin.

What drug class is Azidobenzylpenicillin in?

Azidobenzylpenicillin belongs to the azidocillin class. See all azidocillin drugs at /class/azidocillin.

What development phase is Azidobenzylpenicillin in?

Azidobenzylpenicillin is in Phase 2.

Drug class: All azidocillin drugs
Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Respiratory tract infection

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