NIH Highlighted Topic: Novel Targets, Methods, and Pharmacological Approaches to Treat Substance Use Disorder
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 encouraging innovative research proposals focused on discovering novel therapeutic targets, pharmacological approaches, and advanced drug discovery methods for the treatment and prevention of substance use disorders (SUDs). This highlighted topic supports multidisciplinary efforts integrating molecular biology, computational modeling, artificial intelligence (AI), machine learning (ML), multi-omics analysis, and advanced screening technologies to accelerate the development of next-generation SUD therapies.
NIH is particularly interested in projects leveraging cutting-edge technologies such as single-cell and spatial transcriptomics, proteomics, virtual screening, generative AI, computational drug discovery, molecular simulations, DNA-encoded libraries, PROTACs, molecular glues, and big data analytics to identify and validate novel disease-relevant targets. Companies developing AI-enabled drug discovery platforms, computational biology tools, pharmacology technologies, precision medicine systems, or advanced therapeutic development platforms may be strong candidates for funding.
Areas of interest include target identification and validation, lead compound optimization, predictive pharmacokinetic modeling, drug repurposing, protein-ligand interaction analysis, treatment approaches for polysubstance use, and therapeutics addressing SUD comorbidities such as HIV, chronic pain, and neuropsychiatric disorders. NIH is also encouraging research focused on sex-specific molecular profiling and treatment responses in women.
Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on the project’s scope and translational potential.
This highlighted topic is supported primarily by the National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the Office of Research on Women’s Health (ORWH), all of which are seeking transformative innovations that improve the prevention, diagnosis, and treatment of substance use disorders and alcohol use disorder (AUD).
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 therapeutic platforms, computational drug discovery technologies, pharmacological tools, and precision medicine solutions related to substance use disorders (SUDs) and alcohol use disorder (AUD).
Eligible activities may include:
AI and machine learning platforms for drug discovery and target identification
Computational biology and multi-omics analysis tools
Single-cell and spatial transcriptomics technologies
Proteomics and molecular profiling platforms
Virtual screening systems for ultra-large compound libraries
DNA-encoded library screening technologies
PROTACs, molecular glues, and induced-proximity therapeutic platforms
Drug repurposing and predictive pharmacology systems
Protein-ligand interaction modeling and molecular dynamics simulations
Precision medicine approaches for SUD and AUD treatment
Technologies addressing polysubstance use and co-occurring disorders
Predictive ADME, pharmacokinetic, and drug-drug interaction modeling tools
AI-enabled therapeutic design and lead optimization systems
Biomarker discovery and molecular target validation platforms
Neuropsychiatric and addiction-focused therapeutic development
Sex-specific treatment response and women’s health research technologies
Prototype development, preclinical validation, and translational research
Commercialization planning, regulatory preparation, and scale-up activities
Funding may also support personnel, laboratory testing, cloud computing infrastructure, software development, computational modeling, medicinal chemistry, preclinical studies, data acquisition, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable therapeutic or health technology 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:
Triple your likelihood of success through proven strategy and insider-aligned proposal development
Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations
Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.
