FDA’s designation provides FG-2101 with an additional five years of market exclusivity and priority review
SAN DIEGO, Oct. 13, 2025 /PRNewswire/ — Blacksmith Medicines, Inc. (Blacksmith), a leading biopharma dedicated to discovering and developing medicines targeting metalloenzymes, announced today that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and the Fast Track Designation under the Generating Antibiotic Incentives Now (GAIN) Act for FG-2101. This novel small molecule inhibitor of LpxC is in development for the treatment of serious infections caused by Gram-negative bacteria including multidrug-resistant strains.
“We are pleased to receive the QIDP and Fast Track designations for FG-2101 as a first-in-class, Gram-negative antibiotic addressing serious unmet needs of public health and national security,” said Zachary Zimmerman, Ph.D., CEO and co-founder of Blacksmith.
The QIDP and Fast Track designations were created as part of the Food and Drug Administration Safety and Innovation Act, FDASIA (June 2012), Title VIII – Generating Antibiotic Incentives Now (GAIN), to create incentives for the development of antibacterial drug products that treat serious or life-threatening infections. These designations by the FDA offer several benefits including:
- Fast Track Designation – Designed to expedite the review of new medicines for treating serious diseases like life-threatening infections and provide a more rapid path to market creating faster access to patients
- Priority Review – Under Priority Review, the FDA will complete application review in 6 months versus the standard 10+ months
- Extended Market Exclusivity – QIDP designation provides an additional 5 years of market exclusivity and rewards companies for developing drugs to treat serious infectious diseases
The FG-2101 program is currently supported under a contract with NIAID (75N93022C00060).
About LpxC
LpxC, a zinc hydrolase, is an attractive and highly sought-after antibiotic target – it is conserved across Gram-negative bacteria and not found in Gram-positive bacteria or human cells. Inhibiting LpxC results in potent killing of Gram-negative bacteria with the benefit of sparing Gram-positive bacteria, such as those residing in the protective microbiome of the gut, which help to deter opportunistic C. difficile infections.
Other LpxC inhibitors have been evaluated by biopharma in the past, but chemistry limitations (e.g. hydroxamic acid) have yielded ineffective compounds that suffer from poor drug-like properties. Thus, there are no approved therapeutics targeting LpxC. Blacksmith, using its proprietary chemistry platform, has developed novel non-hydroxamate inhibitors of LpxC that are safe and effective in animal models of Gram-negative infection and are able to kill Gram-negative ‘superbugs’ where other antibiotics are ineffective.
About metalloenzymes and the Blacksmith platform
Metalloenzymes utilize a metal ion cofactor in the enzyme active site to perform essential biological functions. This diverse class of targets has historically been difficult to drug due to small molecule chemistry limitations that have plagued the industry. The Blacksmith metalloenzyme platform has solved this problem by leveraging the following:
- A large proprietary fragment library of metal-binding pharmacophores (MBPs);
- A comprehensive database containing a full characterization of the metalloenzyme genome including functions, metal cofactors, and associations to disease;
- A first-of-its-kind metallo-CRISPR library of custom single guide RNAs;
- An industry-leading metalloenzyme computational toolkit for docking, modeling and structure-based drug design; and
- A robust and blocking intellectual property estate covering bioinorganic, medicinal, and computational chemistry approaches for metalloenzyme-targeted medicines.
About Blacksmith Medicines
At Blacksmith Medicines, we are developing medicines targeting metal-dependent enzymes. Over 30% of known enzymes are metalloenzymes, covering all major enzyme classes: oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases. Metal ions, including magnesium, zinc, iron, manganese and copper, are the essential ingredient in these metalloenzymes. We recognized a large unmet need for new chemical matter and innovative approaches to drug this important class of enzymes. Our purpose-built platform for metalloenzyme-targeted medicines combines, for the first time in industry, a focused library of metal-binding pharmacophores with proprietary computational modeling approaches to rapidly and rationally design small molecule inhibitors that interact with key metal ions in the enzyme’s active site. Our comprehensive knowledge of the metal environment and key active site interactions enables Blacksmith to rapidly build potent and selective inhibitors in a stepwise and predictable manner.
Blacksmith has executed strategic drug discovery collaborations with Basilea Pharmaceutica International Ltd., Cyteir Therapeutics Inc., Eli Lilly and Company (Lilly), Hoffmann-La Roche Ltd., and Zoetis LLC., and has been awarded non-dilutive Federal funding agreements with CARB-X and NIH/NIAID. Blacksmith investors include Lilly, Evotec A.G., MP Healthcare Partners, MagnaSci Ventures, and Alexandria Venture Investments.
For further information, please visit the company’s website www.BlacksmithMedicines.com and LinkedIn
Media Contact:
Amy Conrad
Juniper Point
[email protected]
858-366-3243
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SOURCE Blacksmith Medicines
