Blacksmith Medicines receives FDA qualified infectious disease product and fast track designation for FG-2101, a novel antibiotic targeting LpxC

Blacksmith Medicines

13 October 2025 - Blacksmith Medicines announced today that the US FDA has granted qualified infectious disease product 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 multi-drug-resistant strains.

Read Blacksmith Medicines press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track