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NOTE: The Solicitations and topics listed on this site are copies from the various SBIR agency solicitations and are not necessarily the latest and most up-to-date. For this reason, you should visit the respective agency SBIR sites to read the official version of the solicitations and download the appropriate forms and rules.


If no search results for your keyword(s) were found, you are encouraged to review Agency omnibus solicitations for additional funding opportunities. Omnibus solicitations are structured to be broad, extensive Programmatic issuances with research areas related to the petitioning Agency and are not limited to predetermined Topics/Subtopics. If upon reviewing you have additional questions, you may consider reaching out to the respective Agency for clarification regarding acceptable proposals (https://www.sbir.gov/agency-contacts).

  1. RFA-DA-25-054: Harnessing Artificial Intelligence and Polypharmacology to Discover Pharmacotherapeutics for Substance Use Disorders (R43/R44 Clinical Trials Not Allowed)

    Release Date: 01-29-2024Open Date: 06-25-2024Due Date: 07-25-2024Close Date: 07-26-2024

    Background: Drug discovery and development is a high-cost, high-risk, and time-consuming endeavor where the failure rate of therapeutic candidates that enter clinical trials is 90%. Because of this, in recent years, artificial intelligence (AI), including machine learning ( ML) technologies, has been embraced to reduce clinical failure rates and to speed up drug discovery. AI/ML technologies are ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  2. RFA-DA-25-053: Harnessing Artificial Intelligence and Polypharmacology to Discover Pharmacotherapeutics for Substance Use Disorders (R41/R42 Clinical Trials Not Allowed)

    Release Date: 01-29-2024Open Date: 06-25-2024Due Date: 07-25-2024Close Date: 07-26-2024

    Background: Drug discovery and development is a high-cost, high-risk, and time-consuming endeavor where the failure rate of therapeutic candidates that enter clinical trials is 90%. Because of this, in recent years, artificial intelligence (AI), including machine learning (ML) technologies, has been embraced to reduce clinical failure rates and to speed up drug discovery. AI/ML technologies are u ...

    STTRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  3. PAR-24-107: Solutions to Enable Regional Genomic Medicine eConsult Services (R41/R42 Clinical Trial Optional)

    Release Date: 01-09-2024Open Date: 04-30-2024Due Date: 05-30-2024Close Date: 05-31-2024

    Purpose This Notice of Funding Opportunity (NOFO) invites applications from eligible small businesses to develop solutions for commercialization that can be used to enable regional clinician-to-clinician genomic medicine eConsult services. Specifically, we seek products, such as technologies or services, that will allow for the development and sustainment of eConsult services. Eligible United Sta ...

    STTRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  4. PAR-24-099: NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

    Release Date: 01-29-2024Open Date: 04-12-2024 Due Dates: Multiple Close Date: 01-14-2027

    Purpose This Notice of Funding Opportunity (NOFO) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials, including mechanistic studies associated with clinical trials. This program provides support for milestone-driven, hypothesis-driven clinical trials related to the research mi ...

    SBIRPhase IIDepartment of Health and Human ServicesNational Institutes of Health
  5. RFA-AA-24-001: High-Throughput Screening (HTS) Platform for Discovery of Medications to Treat Alcohol Use Disorder (R43/R44 Clinical Trials Not Allowed)

    Release Date: 12-21-2023Open Date: 03-05-2024Due Date: 04-09-2024Close Date: 04-10-2024

    Drug development is challenging, particularly for Central Nervous System (CNS) medications. It takes approximately 18 years to move a potential CNS medication from its initial discovery phase to the marketplace, often costing several billion dollars. The failure rate is high (only 8% of new CNS compounds entering Phase I studies will reach the market) and contributes to the high costs and slow rat ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  6. RFA-AA-24-002: High-Throughput Screening (HTS) Platform for Discovery of Medications to Treat Alcohol Use Disorder (R41/R42 Clinical Trials Not Allowed)

    Release Date: 12-21-2023Open Date: 03-05-2024Due Date: 04-09-2024Close Date: 04-10-2024

    Drug development is challenging, particularly for Central Nervous System (CNS) medications. It takes approximately 18 years to move a potential CNS medication from its initial discovery phase to the marketplace, often costing several billion dollars. The failure rate is high (only 8% of new CNS compounds entering Phase I studies will reach the market) and contributes to the high costs and slow rat ...

    STTRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  7. PAR-24-096: Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

    Release Date: 01-22-2024Open Date: 02-22-2024 Due Dates: Multiple Close Date: 06-23-2026

    A biomarker is a defined characteristic that is measured as an indicator of a normal biological process, pathogenic process, or responses to an exposure or intervention, including therapeutic interventions. Biomarker modalities are diverse, and can include ‘omics, imaging, behavioral, digital and physiologic endpoints. Because the measurement of the biomarker is integral to defining the biomarke ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  8. PAR-24-098: Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

    Release Date: 01-22-2024Open Date: 02-22-2024 Due Dates: Multiple Close Date: 06-26-2026

    Background A biomarker is a defined characteristic that is measured as an indicator of a normal biological process, pathogenic process, or responses to an exposure or intervention, including therapeutic interventions. Biomarker modalities are diverse, and can include ‘omics, imaging, behavioral, digital and physiologic endpoints. Because the measurement of the biomarker is integral to defining ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  9. RFA-DA-25-052: Tools for decentralized clinical trials for substance use disorder (R43/R44 Clinical Trials Optional)

    Release Date: 10-25-2023Open Date: 02-14-2024Due Date: 03-14-2024Close Date: 03-15-2024

    Substance use disorder (SUD) clinical trials traditionally perform recruitment, enrollment, interventions, as well as information collection at the clinical trial sites. In-person visits at the sites are used for screening, assignment to interventions, treatment or other intervention, follow up, as well as collection of information from participants and entering it in a database. Some of the in-p ...

    SBIRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
  10. RFA-DA-25-051: Tools for Decentralized Clinical Trials for Substance Use Disorder (R41/R42 Clinical Trials Optional)

    Release Date: 10-25-2023Open Date: 02-14-2024Due Date: 03-14-2024Close Date: 03-15-2024

    Substance use disorder (SUD) clinical trials traditionally perform recruitment, enrollment, interventions, as well as information collection at the clinical trial sites. In-person visits at the sites are used for screening, assignment to interventions, treatment or other intervention, follow up, as well as collection of information from participants and entering it in a database. Some of the in-p ...

    STTRPhase I/Phase IIDepartment of Health and Human ServicesNational Institutes of Health
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