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Blacksmith Medicines’ FG-2101 Receives QIDP and Fast Track Designations from FDA for Gram-Negative Infections

15 Oct 2025
Admin
News Article

Blacksmith Medicines’ FG-2101 Receives QIDP and Fast Track Designations from FDA for Gram-Negative Infections

First-in-class LpxC inhibitor targets multidrug-resistant bacteria

Cambridge, MA, Blacksmith Medicines, Inc., a biopharmaceutical company focused on developing therapies targeting metalloenzymes, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for FG-2101, a novel small-molecule LpxC inhibitor in development for serious infections caused by Gram-negative bacteria, including multidrug-resistant strains.

“We are pleased to receive these designations for FG-2101, a first-in-class antibiotic addressing urgent public health needs and national security threats.”

Zachary Zimmerman, Ph.D., CEO and co-founder of Blacksmith Medicines.

FDA Designations and Benefits

Both QIDP and Fast Track designations aim to accelerate the development of therapies for serious or life-threatening infections. Key benefits include:

Fast Track: Expedited review to bring medicines for serious conditions to patients more quickly.
Priority Review: FDA target review time reduced to 6 months versus the standard 10+ months.
Extended Market Exclusivity: QIDP designation provides an additional 5 years of market protection.

FG-2101 is currently supported under a contract with NIAID (75N93022C00060).

FG-2101 and LpxC Inhibition

LpxC, a zinc-dependent hydrolase, is highly conserved across Gram-negative bacteria and absent in human cells and Gram-positive bacteria. Inhibiting LpxC results in potent, selective killing of Gram-negative pathogens while sparing beneficial microbiome bacteria, helping reduce risks of opportunistic infections like C. difficile.

Previous LpxC inhibitors suffered from poor drug-like properties, limiting efficacy. Using its proprietary chemistry platform, Blacksmith has developed non-hydroxamate LpxC inhibitors that are safe, effective in preclinical models, and active against multidrug-resistant Gram-negative “superbugs.”

Blacksmith’s Metalloenzyme Platform

Blacksmith Medicines specializes in metal-dependent enzymes, which constitute over 30% of known enzymes across all major classes. The company’s platform integrates:

A proprietary fragment library of metal-binding pharmacophores (MBPs)
A metalloenzyme genome database with disease associations
A custom metallo-CRISPR library for target validation
Advanced computational modeling tools for structure-based drug design
A robust IP estate covering bioinorganic, medicinal, and computational chemistry approaches

This platform enables rapid design of potent, selective inhibitors that interact precisely with metal ions in enzyme active sites.

About Blacksmith Medicines

Blacksmith Medicines is a pioneering biopharmaceutical company developing therapies for diseases driven by metalloenzymes. The company has executed strategic collaborations with Basilea Pharmaceutica, Cyteir Therapeutics, Eli Lilly, Roche, and Zoetis, and received non-dilutive federal funding from CARB-X and NIH/NIAID.

Investors include Eli Lilly, Evotec, MP Healthcare Partners, MagnaSci Ventures, and Alexandria Venture Investments.