Skip to main content
        
        U.S. flag
                An official website of the United States government
                    Here’s how you know
                Here’s how you know**Official websites use .gov**
                        
                        A **.gov** website belongs to an official government organization in the United States.
            **Secure .gov websites use HTTPS**
                        
                        A **lock** (
                        Locked padlock icon
                        ) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.Search
    Menu

        Search for Information from NIDDK
            
            Entire Site
                Research & Funding
                Health Information
                News
                About NIDDKSearch

Home
            Research & Funding
                                Expand Research & Funding
                                Current Funding Opportunities
                                                    Research Programs & Contacts
                                                    Human Subjects Research
                                                    Funding Process
                                            Research Training & Career Development
                                                    Funded Grants & Grant History
                                                    Research Resources
                                            Research at NIDDK
                                                    Technology Advancement & Transfer
                                                    Meetings & Workshops
                        Health Information
                                Expand Health Information
                                Health Topics
                                                                                                    Diabetes
                                                    Digestive Diseases
                                                    Kidney Disease
                                                    Weight Management
                                                    Liver Disease
                                                    Urologic Diseases
                                                    Endocrine Diseases
                                                    Diet & Nutrition
                                                    Blood Diseases
                                                    Diagnostic Tests
                                            La información de la salud en español
                                                    Health Statistics
                                                    Healthy Moments Radio Broadcast
                                                    Clinical Trials
                                            For Health Professionals
                                                    Diabetes Discoveries & Practice Blog
                                                    Community Health & Outreach
                        News
                                Expand News
                                News Archive
                                                    For Reporters
                                            Meetings & Workshops
                                                    Media Library
                                            Follow Us
                        About NIDDK
                                Expand About NIDDK
                                Meet the Director
                                                    Offices & Divisions
                                                    Staff Directory
                                                    Budget & Legislative Information
                                            Advisory & Coordinating Committees
                                                    Strategic Plans & Reports
                                                    Research Areas
                                                    FAQs
                                            Jobs at NIDDK
                                                    Visit Us
                                                    Contact Us Home
                    Research & Funding
                    Research Programs & Contacts
                    Translational Research
                    Pre-Clinical Development

    Related Topics
        Translational Research
        Disease Biology
                Target Identification
                Assay Development
                Screening
                Hit to Lead
                Lead Optimization
                Pre-Clinical Development
                Clinical DevelopmentTranslational Research: Pre-Clinical Development
    The pre-clinical development of a potential therapeutic agent involves the manufacturing and formal testing of ADMET properties
in preparation for submission to a regulatory agency for human trials. Rigorous efficacy studies of a pre-clinical lead
candidate may also be conducted. These processes require regulatory expertise in their design, good manufacturing practices
(GMP) manufacturing, and good laboratory practice (GLP) toxicology studies as well as consideration of future clinical
trial design.

    
Starting Points
    DiseaseBiology
                        
                    
                    
                    Previous
            UnvalidatedTarget
                Target ID
                        
                    
                    PutativeTargets
                    Previous
                                                    Next
            NominatedTarget
                Assay Development
                        
                    
                    ScreenableAssays
                    Previous
                                                    Next
            Target Assay
                Screening
                        
                    
                    Hits andStarting Points
                    Previous
                                                    Next
            Hit
                Hit to Lead
                        
                    
                    Lead Series
                    Previous
                                                    Next
            LeadCompound
                LeadOptimization
                        
                    
                    PotentialTherapeuticLeads
                    Previous
                                                    Next
            Pre‐clinicalCandidate
                Pre‐clinicalDevelopment
                        
                    
                    ClinicalTherapeuticCandidate
                    Previous
                                                    Next
            ClinicalCandidate
                ClinicalDevelopment
                        
                    
                    Clinical Proofof Concept
                    Previous
                                                    Next
            Licensing andCommercializa-tion Partners
                    
                    Market-readyTherapeuticsOutcomes and Resources


NIH Funding Opportunities
PAR-22-111, Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (R01 Clinical Trial Not Allowed) has expired. The NIDDK is still interested in supporting this type of translational science and another potential option is to apply to the Parent R01 NOFO (PA-20-185) and consider requesting review assignment to any ofCSR’s Drug Synthesis, Discovery, Disposition, and Xenobiotics study sections, or another relevant review panel. Applicants should consult the NIH/CSR study section descriptionsbefore requesting a specific review panel.
    RFA-NS-24-019, HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)Related Resources
Bridging Interventional Development Gaps (BrIDGs)
    Therapeutics for Rare and Neglected Diseases (TRND)
    Academic Drug Discovery Consortium
    NIDDK Small Business Programs
    IND/FDAStaff Contacts
**Division of Kidney, Urologic, and Hematologic Diseases**Dr. Anna Sadusky
**Division of Digestive Diseases and Nutrition**Dr. Bonnie Burgess-Beusse
**Division of Diabetes, Endocrinology, and Metabolic Diseases**Dr. Yan Li        Last Reviewed October 2023 Contact Us
**Hours:** 8:30 a.m. to 5 p.m. ET, Monday - Friday**Email:** healthinfo@niddk.nih.gov**Phone:** +1-800-860-8747**TTY:** +711
Chat
Live Chat Available8:30 a.m - 5 p.m. ETMonday - Friday
Follow Us
LinkedIn
X
Facebook
YouTube
InstagramNIH... Turning Discovery Into Health ®
Privacy Policy
    Freedom of Information Act
    Accessibility
    Disclaimers
    Copyright
    Vulnerability Disclosure Policy
Site Map
    For Staff Only
    Get Email Updates
U.S. Department of Health and Human Services
    National Institutes of Health