Funding Objective: The NIARR is issuing this Request for Proposals (RFP) to support the advancement of novel antimicrobial agents that specifically target WHO priority multi-drug resistant (MDR) pathogens, excluding tuberculosis.

Eligible Phases: This grant is specifically structured to fund Investigational New Drug (IND)-enabling studies, First-in-Human (Phase I) trials, and/or initial Proof-of-Concept (Phase IIa) efficacy trials.

Recipient Eligibility: Applications are accepted from U.S. and international academic institutions, non-profit research hospitals, and for-profit biopharmaceutical companies with robust preclinical data packages. The Principal Investigator (PI) must be able to demonstrate significant experience in drug development and clinical trial management.

Award Structure: Grants will be awarded as a cooperative agreement (U-award), requiring active collaboration and participation with NIARR scientific staff.

Financial Details: The maximum award ceiling is $10 Million USD per project over a period of up to four years. Funds are released based on the successful achievement of pre-defined clinical milestones (e.g., successful dosing of the first cohort, completion of Phase I safety review).

Required Documentation: Submissions must include detailed preclinical toxicology and pharmacology data, a comprehensive clinical trial protocol (or draft), an updated regulatory submission strategy (e.g., FDA/EMA), and a clear commercialization plan to ensure eventual patient access.

Impact Metric: A key evaluation criterion is the potential of the compound to demonstrate a novel Mechanism of Action (MOA) that circumvents existing resistance pathways.