Last reviewed 2026-05-14 · How we verify

erythromycin [Eritex]

Hoffmann-La Roche · Phase 3 active Small molecule

erythromycin [Eritex] is a macrolide antibiotic Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Acute bacterial exacerbation of chronic bronchitis, Acute bacterial sinusitis, Community-acquired pneumonia.

Erythromycin inhibits protein synthesis by binding to the 50S subunit of the bacterial ribosome.

Erythromycin inhibits protein synthesis by binding to the 50S subunit of the bacterial ribosome. Used for Acute bacterial exacerbation of chronic bronchitis, Acute bacterial sinusitis, Community-acquired pneumonia.

Likelihood of approval

63.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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.
Big-pharma sponsor +3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	erythromycin [Eritex]
Sponsor	Hoffmann-La Roche
Drug class	macrolide antibiotic
Target	50S ribosomal subunit
Modality	Small molecule
Therapeutic area	Infectious diseases
Phase	Phase 3

Mechanism of action

This action prevents the elongation of peptide chains, ultimately leading to the death of the bacterial cell. Erythromycin is a bacteriostatic agent, meaning it does not kill bacteria directly but rather inhibits their growth and replication.

Approved indications

Acute bacterial exacerbation of chronic bronchitis
Acute bacterial sinusitis
Community-acquired pneumonia
Pharyngitis and tonsillitis caused by Streptococcus pyogenes
Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes

Common side effects

Nausea
Vomiting
Abdominal pain
Diarrhea
Headache

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

erythromycin [Eritex] CI brief — competitive landscape report
erythromycin [Eritex] updates RSS · CI watch RSS
Hoffmann-La Roche portfolio CI

Frequently asked questions about erythromycin [Eritex]

What is erythromycin [Eritex]?

erythromycin [Eritex] is a macrolide antibiotic drug developed by Hoffmann-La Roche, indicated for Acute bacterial exacerbation of chronic bronchitis, Acute bacterial sinusitis, Community-acquired pneumonia.

How does erythromycin [Eritex] work?

Erythromycin inhibits protein synthesis by binding to the 50S subunit of the bacterial ribosome.

What is erythromycin [Eritex] used for?

erythromycin [Eritex] is indicated for Acute bacterial exacerbation of chronic bronchitis, Acute bacterial sinusitis, Community-acquired pneumonia, Pharyngitis and tonsillitis caused by Streptococcus pyogenes, Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes.

Who makes erythromycin [Eritex]?

erythromycin [Eritex] is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

What drug class is erythromycin [Eritex] in?

erythromycin [Eritex] belongs to the macrolide antibiotic class. See all macrolide antibiotic drugs at /class/macrolide-antibiotic.

What development phase is erythromycin [Eritex] in?

erythromycin [Eritex] is in Phase 3.

What are the side effects of erythromycin [Eritex]?

Common side effects of erythromycin [Eritex] include Nausea, Vomiting, Abdominal pain, Diarrhea, Headache.

What does erythromycin [Eritex] target?

erythromycin [Eritex] targets 50S ribosomal subunit and is a macrolide antibiotic.

Drug class: All macrolide antibiotic drugs
Target: All drugs targeting 50S ribosomal subunit
Manufacturer: Hoffmann-La Roche — full pipeline
Therapeutic area: All drugs in Infectious diseases
Indication: Drugs for Acute bacterial exacerbation of chronic bronchitis
Indication: Drugs for Acute bacterial sinusitis
Indication: Drugs for Community-acquired pneumonia

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