Last reviewed 2026-05-27 · How we verify

Blautix

4D pharma plc · Phase 2 active Biologic ✓ Verified May 2026

Blautix is a Biologic drug developed by 4D pharma plc. It is currently in Phase 2 development. Also known as: MRx1234, Blautia Hydrogenotrophica.

Blautix is a treatment being studied for Irritable Bowel Syndrome in a Phase II clinical trial. The trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of repeated oral administration of Blautix.

Likelihood of approval

15.3% 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).

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	Blautix
Also known as	MRx1234, Blautia Hydrogenotrophica
Sponsor	4D pharma plc
Modality	Biologic
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Trial for New Treatment of Adult Participants With Irritable Bowel Syndrome (PHASE2)

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:

Blautix CI brief — competitive landscape report
Blautix updates RSS · CI watch RSS
4D pharma plc portfolio CI

Frequently asked questions about Blautix

What is Blautix?

Blautix is a Biologic drug developed by 4D pharma plc.

Who makes Blautix?

Blautix is developed by 4D pharma plc (see full 4D pharma plc pipeline at /company/4d-pharma-plc).

Is Blautix also known as anything else?

Blautix is also known as MRx1234, Blautia Hydrogenotrophica.

What development phase is Blautix in?

Blautix is in Phase 2.

Manufacturer: 4D pharma plc — full pipeline
Therapeutic area: All drugs in Other
Also known as: MRx1234, Blautia Hydrogenotrophica

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