FDA Opens Second 2026 Funding Round for Minor Species Drug Development
The FDA has announced a second application period for grants supporting animal drug development for minor species and uncommon diseases, offering up to $750,000 per project to overcome financial barriers in veterinary pharmaceutical development.
Addressing Unmet Medical Needs
The Minor Use and Minor Species (MUMS) grant program provides crucial funding for drug development projects that would otherwise lack economic incentive. The program targets uncommon diseases in major species like horses, dogs, cats, cattle, pigs, turkeys, and chickens, as well as treatments for minor species with limited market potential.
Individual awards can reach $250,000 per year, with maximum funding of $500,000 over two years for routine studies and $750,000 over three years for toxicology studies. This funding structure acknowledges the extended development timelines often required for specialized animal health products.
Legislative Foundation
The program stems from the Minor Use and Minor Species Animal Health Act of 2004, which created innovative pathways to bring products to market for small populations. Before this legislation, veterinary pharmaceutical companies rarely attempted to develop drugs for limited markets due to financial constraints.
The MUMS Act provides several incentives beyond grant funding, including conditional approval pathways that allow products to reach market with preliminary efficacy data while comprehensive studies continue.
Program Impact and Success Stories
Since inception, the MUMS grant program has provided $8.4 million in support across 72 studies spanning diverse species and conditions. Funded projects have addressed critical gaps in veterinary therapeutics across multiple sectors.
Notable successes include treatments for parasitic and bacterial diseases in fish species, essential for sustainable aquaculture operations. The program has also supported development of cancer treatments for companion animals, addressing conditions where few treatment options previously existed.
Eligibility and Application Process
Only sponsors with FDA-designated MUMS drugs or their research partners are eligible to apply. This requirement ensures funding reaches projects with established regulatory pathways and genuine commitment to bringing products to market.
The application timeline runs through January 2026, with optional letters of intent due December 26, 2025, and final applications due January 30, 2026. Applications must be submitted through either the NIH ASSIST system or Grants.gov.
Species-Specific Challenges
Minor species drug development faces unique regulatory and scientific challenges. Unlike major species with extensive safety databases, minor species often lack established dosing regimens, safety margins, and efficacy benchmarks. FDA’s Center for Veterinary Medicine works with sponsors to develop appropriate study designs for these populations.
The program recognizes that one-size-fits-all approaches rarely work for minor species. Flexible regulatory frameworks allow sponsors to propose innovative study designs tailored to specific species biology and husbandry practices.
Economic Barriers in Veterinary Drug Development
Traditional pharmaceutical development models depend on large market potential to justify R&D investments. Minor species markets rarely generate sufficient revenue to support conventional development costs, creating a significant gap in available treatments.
The MUMS program directly addresses this market failure by subsidizing development costs for socially beneficial products. This approach recognizes that animal health extends beyond commercial considerations to include conservation, research, and companion animal welfare.
Future Outlook
The program continues expanding its impact as more sponsors recognize opportunities in underserved markets. Recent years have seen increasing interest in exotic animal medicine and specialized applications in production animals.
As veterinary medicine becomes more sophisticated, demand for species-specific therapies will likely continue growing. The MUMS program provides essential infrastructure to meet these evolving needs while maintaining appropriate safety and efficacy standards.
Interested sponsors should review the complete funding opportunity announcement and FDA guidance documents to understand eligibility requirements and application procedures. Early engagement with FDA’s Office of Minor Use and Minor Species Animal Drug Development can help optimize project design and regulatory strategy.