Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol-related Disorders (U44)
|Incentive Type:||Grant Program|
Health And Safety, Research, Technology
|Governing Body:||National Institutes of Health|
|What’s it worth?:||Not mentioned|
The Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use Disorder and Alcohol-related Disorders program was developed to fund therapeutic agents for disorders that fall under the mission of NIAAA supporting New Drug (IND)-enabling studies for the therapeutic candidate. Successful projects have a minimum of an IND application submitted to the FDA for approval status. Funds may be used to:
- Develop the project plan
- Monitor research progress
- Appropriate go/no-go decision-making
All applicants must have a candidate and meet the following minimal requirements:
- Optimization must be completed and final characterization of the candidate.
- Candidate should have sufficient purity with minimal effective dose, optimal effective dose, time and duration of treatment, deemed as relevant in vivo assays.
- Feasibility for production and reproducible production of the candidate.
Ideal study proposal examples include but are not excluded to:
- Chemistry, manufacturing, and control activities.
- Pharmacokinetic evaluations.
- Necessary therapeutic modalities, final characterization, and definitive verification of in vitro and in vivo activities.
- Preliminary safety.
- Optimization and validation of appropriate assays.
Budgets may be awarded up to $1,000,000 for Phase I projects and $1,500,000 for Phase II projects with a maximum duration of two years for Phase I and three years for Phase II. All applicants must meet the following criteria.
Application packets may be obtained from the Grants.gov website and must be complete and submitted before the deadline.