NCATS Inxight Drugs

NCATS Inxight Drugs provides an integrated, curated database of drug regulatory status and substance information to support translational research and regulatory analysis.

Key Features:

• Extensive Data Integration: Consolidates records for 125,036 product ingredients, including 2,566 FDA-approved drugs, 6,242 marketed drugs, and 9,684 investigational drugs, and integrates data from the U.S. Food and Drug Administration and independent public sources.
• ISO 11238 Standardization: Defines all substances according to ISO 11238 to enable unique drug substance identification and interoperability.
• Manually Curated Literature: Includes manually curated literature data capturing treatment modalities and semantic relationships between substances.
• Novel FDA Drug Approvals: Provides a dedicated resource with regulatory details for newly approved FDA drugs.
• Automated Data Integration and RESTful API: Uses the NCATS Stitcher data integration tool for automated aggregation and exposes full data access via a RESTful API.

Scientific Applications:

• Drug Discovery: Enables exploration of investigational drug records to identify candidate compounds for further study.
• Regulatory Research: Facilitates analysis of approval processes and regulatory status of substances using integrated FDA and public-source data.
• Pharmacovigilance: Supports monitoring of novel drug approvals and associated data for emerging trends and safety profiles.

Methodology:

Integrates FDA and independent public data using the NCATS Stitcher tool, applies ISO 11238 substance definitions, incorporates manual literature curation, and provides automated aggregation with RESTful API access.