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NVP-NK3398

Development stage: Preclinical
Lead developer: NVP Healthcare
Modality: Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration: Oral

Overview

NVP-NK3398 is a microbiome-based therapeutic candidate being developed by NVP Healthcare for the treatment of Major Depressive Disorder (MDD). The drug utilizes the company's proprietary DuoBiome® technology, which is designed to modulate the gut-brain axis through specific microbial interventions. As of 2024, the program is in the IND-enabling stage, having successfully completed a Pre-IND meeting with the U.S. Food and Drug Administration (FDA). NVP Healthcare aims to submit an Investigational New Drug (IND) application in 2026 to initiate Phase 1/2 clinical trials in the United States.

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