Drug intelligence / Profile preview

NGM313

Development stage
Phase 2
Lead developer
KdT Ventures
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Subcutaneous Injection
01

Overview

NGM313 is a humanized monoclonal antibody that acts as a selective agonist of the β-Klotho/FGFR1c receptor complex. By binding to a unique epitope on β-Klotho, it selectively activates FGFR1c signaling—one of the metabolic pathways utilized by FGF21-based ligand therapies—without activating other FGF receptors such as FGFR2c, FGFR3c, or FGFR4[2][7]. This mechanism results in potent insulin-sensitizing effects and significant reductions in liver fat content and key metabolic parameters. Originally developed for metabolic diseases including nonalcoholic steatohepatitis (NASH), type 2 diabetes, and obesity[5][4], NGM313 has demonstrated clinical proof-of-concept for target engagement and favorable tolerability in over 300 subjects[3]. While its development for common metabolic diseases was discontinued after Phase 2 trials due to efficacy thresholds not being met[9], it is now being repurposed by KdT Ventures for evaluation in rare disease indications.

Other names
MK-3655MK3655MK 3655NGM 313NGM313NGM-313
02

Targets

FGFR1 (Fibroblast growth factor receptor 1)

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