Last reviewed 2026-05-28 · How we verify

E. coli ETVAX

Scandinavian Biopharma AB · Phase 2 active Biologic Under review

E. coli ETVAX is a Biologic drug developed by Scandinavian Biopharma AB. It is currently in Phase 2 development for Prevention of E. coli infections.

ETVAX is a vaccine that stimulates the immune system to produce antibodies against E. coli.

The ETVAX vaccine is being studied for its safety, tolerability, and immunogenicity in preventing Escherichia coli diarrhea, specifically Enterotoxigenic Escherichia coli (ETEC) infections. The vaccine is being tested in a randomized, double-blind, placebo-controlled trial in Bangladesh.

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	E. coli ETVAX
Sponsor	Scandinavian Biopharma AB
Modality	Biologic
Therapeutic area	Infectious Diseases
Phase	Phase 2

Mechanism of action

ETVAX works by introducing a weakened form of E. coli to the body, which triggers an immune response and helps the body produce antibodies to fight off future E. coli infections.

Approved indications

Prevention of E. coli infections

Common side effects

Injection site pain

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

E. coli ETVAX CI brief — competitive landscape report
E. coli ETVAX updates RSS · CI watch RSS
Scandinavian Biopharma AB portfolio CI

Frequently asked questions about E. coli ETVAX

What is E. coli ETVAX?

E. coli ETVAX is a Biologic drug developed by Scandinavian Biopharma AB, indicated for Prevention of E. coli infections.

How does E. coli ETVAX work?

ETVAX is a vaccine that stimulates the immune system to produce antibodies against E. coli.

What is E. coli ETVAX used for?

E. coli ETVAX is indicated for Prevention of E. coli infections.

Who makes E. coli ETVAX?

E. coli ETVAX is developed by Scandinavian Biopharma AB (see full Scandinavian Biopharma AB pipeline at /company/scandinavian-biopharma-ab).

What development phase is E. coli ETVAX in?

E. coli ETVAX is in Phase 2.

What are the side effects of E. coli ETVAX?

Common side effects of E. coli ETVAX include Injection site pain.

Manufacturer: Scandinavian Biopharma AB — full pipeline
Therapeutic area: All drugs in Infectious Diseases
Indication: Drugs for Prevention of E. coli infections

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