NIH Highlighted Topic: Accelerating Research in Celiac Disease
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is seeking innovative research proposals through the SBIR Program to accelerate research in celiac disease, including improved diagnostics, immune-based therapeutics, prevention strategies, and technologies that advance understanding of disease pathogenesis. NIH is particularly interested in research that enables earlier and more reliable detection of celiac disease, identifies therapeutic targets, restores gluten tolerance, and improves long-term patient outcomes.
Celiac disease is a complex autoimmune disorder affecting more than 1% of the U.S. population, with incidence continuing to rise. Despite growing awareness and scientific progress, substantial unmet needs remain related to early diagnosis, disease monitoring, treatment resistance, immune dysregulation, microbiome interactions, and prevention. Companies developing diagnostics, therapeutics, microbiome technologies, AI-enabled disease modeling platforms, biomarker tools, digital health solutions, immune-modulating therapies, or advanced research systems relevant to autoimmune gastrointestinal disease may be strong candidates for funding.
NIH is especially interested in projects investigating immune mechanisms, genetic and environmental drivers of disease, microbiome interactions, inflammatory pathways, women’s health considerations, and complications associated with celiac disease, including osteoporosis, oral health disorders, autoimmune co-morbidities, and gastrointestinal cancers. Research utilizing New Approach Methodologies (NAMs), computational modeling, translational studies, and human-relevant disease models is also encouraged.
Through the NIH SBIR Program, U.S. small businesses may apply for up to $323,090 in Phase I funding and up to $2,153,927 in Phase II funding to support research, development, validation, and commercialization activities. Applications are accepted on January 5th, April 5th, and September 5th annually, with funding typically beginning approximately 9 months after submission.
This highlighted topic is supported primarily by the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Dental and Craniofacial Research (NIDCR), and the Office of Research on Women’s Health (ORWH), all of which may give special consideration to high-impact applications advancing autoimmune disease research, gastrointestinal health, cancer prevention, women’s health, microbiome science, and immune therapeutics.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of technologies and therapeutic approaches focused on celiac disease diagnosis, prevention, treatment, and immune system modulation.
Eligible activities may include:
Development of earlier, more reliable diagnostic tools and biomarker technologies for celiac disease
AI and machine learning platforms analyzing autoimmune disease progression and treatment outcomes
Immune-modulating therapies designed to prevent or treat celiac disease and restore gluten tolerance
Research into cellular and molecular mechanisms driving autoimmune tissue damage and inflammation
Microbiome, virome, and gut-environment interaction studies related to celiac disease progression
New Approach Methodologies (NAMs) and advanced disease modeling systems for celiac disease research
Precision medicine approaches evaluating genetic, hormonal, and environmental risk factors
Development of nutritional, dietary, microbiota, or natural-product-based interventions
Technologies addressing refractory celiac disease or poor response to gluten-free diets
Cancer-related celiac disease research, including inflammation-associated gastrointestinal cancers
Research into oral health, bone density, skin disorders, and other co-morbidities associated with celiac disease
Women’s health-focused studies examining reproductive health, pregnancy outcomes, and autoimmune risk
Translational research, preclinical validation, clinical studies, and regulatory preparation activities
Commercialization planning and scale-up activities for diagnostics, therapeutics, and digital health solutions
Funding may also support personnel, laboratory testing, software development, clinical data analysis, prototype fabrication, computational infrastructure, intellectual property protection, commercialization strategy development, and other research and development activities necessary to advance a commercially viable solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
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