Drug intelligence / Profile preview

blautix

Development stage
Phase 2
Lead developer
4D pharma
Modality
Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Oral
01

Overview

Blautix (MRx1234) is an orally administered, single-strain live biotherapeutic product (LBP) containing the bacterium *Blautia hydrogenotrophica*. [1, 5] It was developed by 4D Pharma, which was later acquired by CJ Bioscience, for the treatment of irritable bowel syndrome (IBS), including both constipation-predominant (IBS-C) and diarrhea-predominant (IBS-D) subtypes. [1, 13] The proposed mechanism involves modulating the gut microbiome to restore homeostasis, thereby addressing symptoms like altered bowel habits and visceral hypersensitivity. [2, 4, 7] In a Phase 2 clinical trial, Blautix was administered as an oral capsule and demonstrated a statistically significant improvement in bowel habit compared to placebo, though the composite primary endpoint that also included abdominal pain was not met. [1, 5, 9] The drug was found to be well-tolerated with a safety profile comparable to placebo. [3]

Brand names
Blautix
Other names
Blautia hydrogenotrophica

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