Notice of Intent to Publish a Funding Opportunity Announcement for Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (R43/R44 Clinical Trial Optional)
ID: 357362Type: Forecasted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Small Businesses

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357362
Timeline
    Description

    The National Institutes of Health (NIH) is preparing to publish a Notice of Funding Opportunity (NOFO) aimed at supporting the development of medications for Alcohol Use Disorder (AUD) and alcohol-associated organ damage through the Investigational New Drug (IND)-enabling and early-stage development phases. This funding opportunity is specifically targeted at small businesses that can propose innovative therapeutic agents, with a requirement for applicants to present a therapeutic candidate backed by substantial preliminary data demonstrating its viability for clinical application. The initiative is crucial for advancing potential treatments closer to U.S. Food and Drug Administration (FDA) approval, with the NOFO expected to be published on January 16, 2025, and applications due by April 5, 2025. The estimated award date is September 30, 2025, and projects may begin as early as December 1, 2025, with encouragement for women-owned and socially or economically disadvantaged businesses to apply.

    Point(s) of Contact
    No information provided.
    Files
    No associated files provided.
    Similar Opportunities
    Notice of Intent to Publish a Funding Opportunity Announcement for Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (R41/R42 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Notice of Funding Opportunity (NOFO) aimed at supporting the development of medications for Alcohol Use Disorder (AUD) and Alcohol-Associated Organ Damage (AAOD) through the Investigational New Drug (IND)-enabling and early-stage development process. Eligible applicants, specifically small businesses, are invited to propose projects that advance therapeutic candidates with a solid foundation of background data, facilitating their transition to preclinical and clinical phases of development. This initiative is crucial for addressing the public health challenges associated with alcohol-related conditions, with the NOFO expected to be published on January 16, 2025, and applications due by April 5, 2025. The funding will utilize R41/R42 activity codes, and the estimated award date is September 30, 2025, with project start dates anticipated for December 1, 2025.
    Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to release a Notice of Funding Opportunity (NOFO) aimed at supporting research for the development of medications to prevent and treat substance use disorders (SUDs) and overdose. This initiative will focus on preclinical and clinical research studies that can rapidly advance candidate interventions toward regulatory approval or clinical adoption, encouraging collaborative efforts among experts in various fields such as pharmacology, toxicology, and clinical trials. While applications are not currently being solicited, interested small businesses are encouraged to begin forming partnerships and developing projects in anticipation of the opportunity, with an estimated synopsis post date of August 15, 2025, and a projected award date of July 1, 2026. For further inquiries, potential applicants can contact Drew Townsend, Ph.D., at drew.townsend@nih.gov or by phone at 301-443-4577.
    Forecast to Publish a Funding Opportunity Announcement for Integrative Neuroscience Initiative on Alcoholism (INIA) Consortia (U01 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Funding Opportunity Announcement for the Integrative Neuroscience Initiative on Alcoholism (INIA) Consortia, which will support collaborative research aimed at understanding the brain-body dysregulation associated with excessive alcohol consumption and Alcohol Use Disorder (AUD). This initiative seeks to foster hypothesis-driven research that explores the interactions between alcohol and various causal factors, with a focus on identifying translatable markers and mechanisms for prevention and intervention strategies. The estimated total program funding is $10 million, with approximately 16 awards expected, and interested applicants are encouraged to begin forming collaborations in anticipation of the announcement, which is expected to be posted in October 2025. For further inquiries, potential applicants can contact Mark Egli at mark.egli@nih.gov or by phone at (301) 594-6392.
    Forecast to Publish a Funding Opportunity Announcement for Copy of Integrative Neuroscience Initiative on Alcoholism (INIA) Consortia Research Resource (U24) (Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Funding Opportunity Announcement for the renewal of the Integrative Neuroscience Initiative on Alcoholism (INIA) Consortia Research Resource (U24), with a focus on studying the brain-body dysregulation associated with excessive alcohol consumption and Alcohol Use Disorder (AUD). This initiative aims to support two collaborative research consortia through a competitive process, encouraging innovative research that examines the interactions between alcohol and various causal influences, while promoting the use of advanced tools and technologies to enhance understanding of brain function related to alcohol misuse. The estimated total program funding is $700,000, with two awards expected, and interested applicants are encouraged to begin forming collaborations in anticipation of the announcement, which is expected to be posted on October 1, 2025, with applications not currently being solicited. For further inquiries, potential applicants can contact Mark Egli at mark.egli@nih.gov or by phone at 301-594-6392.
    Alcohol Treatment, Pharmacotherapy, and Recovery Research (R01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the Alcohol Treatment, Pharmacotherapy, and Recovery Research grant, specifically under the R01 Clinical Trial Required mechanism. This funding opportunity aims to advance research on Alcohol Use Disorder (AUD) by focusing on various aspects such as medication development, behavioral therapies, recovery mechanisms, and innovative treatment technologies. The NIH emphasizes the importance of addressing AUD, particularly for underserved populations, and seeks projects that translate neuroscience research into practical applications. Interested applicants can apply for a grant with an award ceiling of $500,000, with the application process opening on January 5, 2025, and submissions due by September 7, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information page at https://grants.nih.gov/grants/guide/pa-files/PA-25-163.html.
    Alcohol Treatment, Pharmacotherapy, and Recovery Research (R34 Clinical Trial required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for research on Alcohol Treatment, Pharmacotherapy, and Recovery under the R34 Clinical Trial required mechanism. This initiative aims to address the treatment gap for individuals with alcohol use disorder (AUD) by focusing on five key areas: increasing access to treatment, enhancing treatment appeal, examining cost structures, studying dissemination of evidence-based approaches, and reducing health disparities. With AUD being a significant global health issue, this funding seeks to improve treatment methods and recovery pathways, particularly for underserved populations. Applications will be accepted starting January 16, 2025, with a maximum project period of three years and direct costs capped at $450,000. Interested applicants can find more information and submit inquiries via grantsinfo@nih.gov or visit the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-193.html.
    Forecast to Publish a Funding Opportunity Announcement for Copy of Integrative Neuroscience Initiative on Alcoholism (INIA) Consortia Administrative Resource Core (U24) (Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Funding Opportunity Announcement for the renewal of the Integrative Neuroscience Initiative on Alcoholism (INIA) Consortia Administrative Resource Core (U24), which is a cooperative agreement aimed at advancing research on alcohol use disorder (AUD). This initiative will support two collaborative research consortia focused on understanding the brain-body interactions that contribute to excessive alcohol consumption and AUD, encouraging innovative research methodologies and the use of advanced technologies. The estimated total program funding is $1,200,000, with two awards expected, and interested applicants are encouraged to begin forming collaborations in anticipation of the application process, which is expected to open in October 2025. For further inquiries, potential applicants can contact Mark Egli at Mark.Egli@nih.gov or by phone at 301-594-6382.
    Forecast to Publish a Funding Opportunity Announcement for the Consortium on the Neurobiology of Adolescent Drinking in Adulthood (NADIA) Research Resource (Collaborative U24 - Clinical Trials not allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Notice of Funding Opportunity (NOFO) for the Consortium on the Neurobiology of Adolescent Drinking in Adulthood (NADIA) Research Resource, aimed at investigating the long-term effects of adolescent alcohol exposure on brain-behavior relationships. This initiative seeks to support collaborative research across various institutions to elucidate the mechanisms behind persistent changes in brain maturation and adult outcomes due to adolescent drinking, ultimately contributing to improved treatment methods and prevention strategies for alcohol-related issues. The funding will be provided through a Cooperative Agreement, with an expected award date in May 2026, and interested small businesses are encouraged to begin forming collaborations in anticipation of the application process. For further inquiries, potential applicants can contact Dr. Mohammed Akbar at akbarm@mail.nih.gov or by phone at 301-443-6009.
    Alcohol Health Services Research (R01 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute on Alcohol Abuse and Alcoholism (NIAAA), has announced a funding opportunity titled "Alcohol Health Services Research (R01 Clinical Trial Optional)" aimed at addressing the treatment gap for individuals with Alcohol Use Disorder (AUD). This initiative focuses on five key areas: increasing access to treatment, enhancing the appeal of treatment options, analyzing cost structures and insurance systems, studying the dissemination of evidence-based practices, and reducing health disparities among affected populations. The program encourages innovative research designs and participation from diverse organizations, with a maximum budget of $500,000 available for direct costs over a five-year project period. Interested applicants can submit proposals starting January 5, 2025, and should direct inquiries to grantsinfo@nih.gov for further information.
    Forecast to Publish a Funding Opportunity Announcement for the Consortium on the Neurobiology of Adolescent Drinking in Adulthood (NADIA) Administrative Resource (Collaborative U24 - Clinical Trials not allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Notice of Funding Opportunity (NOFO) for the Consortium on the Neurobiology of Adolescent Drinking in Adulthood (NADIA) Administrative Resource, which will be structured as a Cooperative Agreement. This initiative aims to solicit research applications that investigate the mechanisms of persistent changes in brain-behavior relationships following adolescent alcohol exposure, with a focus on enhancing treatment methods and prevention strategies for alcohol-related issues. The funding opportunity is particularly relevant for small businesses with expertise in molecular insights and collaborative investigations, as it seeks to establish a foundational knowledge base across various research fields. Interested applicants should note that applications are not currently being solicited, but they can prepare for submission as the estimated synopsis will be posted on July 30, 2025, with a closing date of September 30, 2025, and an anticipated award date of May 30, 2026. For further inquiries, potential applicants can contact Dr. Mohammed Akbar at akbarm@mail.nih.gov or by phone at 301-443-6009.