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Our Pipeline

A deep portfolio against drug-resistant infections: one market-ready asset, one preclinical development candidate, and earlier-stage hits behind them.

Programs

Anti-infective programs in development.

Fedora is advancing a diversified portfolio of innovative discovery-, preclinical-, and clinical-stage assets targeting the most urgent unmet needs in infectious diseases, focused on difficult-to-treat, multidrug-resistant bacterial infections where the clinical need and market opportunity are greatest.

These compounds and their uses are investigational and have not all been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview and should not be construed as a recommendation for use of any product for unapproved uses.

NacubactamDBO-class β-lactamase inhibitor · cefepime or aztreonam combination

A broad-spectrum β-lactamase inhibitor from the diazabicyclooctane (DBO) class with a distinct dual mechanism of action that pairs β-lactamase inhibition with direct antibacterial activity against an essential penicillin-binding protein. Used in combination with cefepime or aztreonam, it restores coverage against serious drug-resistant infections, including carbapenem-resistant Enterobacterales (CRE). Phase 3 combination trials completed by co-discoverer Meiji Seika achieved high clinical and microbiological success.

Target / IndicationcUTI, HABP/VABP, cIAI
StagePhase 3 completed
DiscoveryPreclinicalPhase 1Phase 2Phase 3Approval & Launch
FPI-2119First-in-class non-β-lactam PBP inhibitor

A first-in-class, non-β-lactam penicillin-binding protein (PBP) inhibitor derived from the lactivicin family of natural products (an under-explored class) with broad-spectrum activity against multidrug-resistant Gram-negative pathogens, including carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacterales. Efficacious in multiple murine infection models (bacteremia, UTI, thigh, and lung).

Target / IndicationcUTI, HABP/VABP
StageDevelopment candidate · IND-enabling studies planned
DiscoveryPreclinicalPhase 1Phase 2Phase 3Approval & Launch
Other ProgramsHit-to-lead discovery · WHO priority pathogens

Hit-identification and hit-to-lead programs pursuing novel scaffolds and early lead compounds against WHO critical- and high-priority pathogens, including carbapenem-resistant Pseudomonas aeruginosa and Acinetobacter baumannii, multidrug-resistant Neisseria gonorrhoeae, and Mycobacterium tuberculosis.

Target / IndicationHABP/VABP, tuberculosis, STI (gonorrhea)
StageDiscovery (hit-to-lead)
DiscoveryPreclinicalPhase 1Phase 2Phase 3Approval & Launch
Fedora scientist working at the laboratory bench
The science

Advancing the fight against antimicrobial resistance.

Addressing the global antibiotic resistance crisis, Fedora's team is committed to discovering and developing the next generation of antibacterial medicines. Our mission is to protect patients, strengthen healthcare systems, and preserve the effectiveness of antibiotic therapies for decades to come.

Our core programs focus on the discovery and development of innovative treatments targeting Gram-negative pathogens identified by the World Health Organization as critical threats. These include multidrug-resistant Escherichia coli, Klebsiella pneumoniae, Enterobacter species, carbapenem-resistant Enterobacterales, and difficult-to-treat Pseudomonas aeruginosa.

01

The AMR threat

Bacteria continuously evolve to survive medicines that once eliminated them. As resistance spreads, existing antibiotics become less effective, making infections harder to treat and increasing the risk of severe outcomes. The need for new antibacterial therapies is urgent and ongoing.

02

Our β-lactam enhancer

Nacubactam is a next-generation β-lactam enhancer that combines potent β-lactamase inhibition with direct antibacterial activity through binding to penicillin-binding proteins. This dual mechanism represents a novel approach designed to overcome some of the most challenging resistance mechanisms found in Gram-negative pathogens.

03

First-in-class antibacterial agent

FPI-2119 is a first-in-class, non-β-lactam penicillin-binding protein inhibitor derived from the lactivicin family of natural products. It represents an entirely new strategy for targeting bacterial cell-wall synthesis and has demonstrated potent activity against a range of multidrug-resistant pathogens.

Partnering & licensing

Fedora seeks partnerships with industry, academia, and governments to move the pipeline forward.

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