Active Pharmaceutical Ingredients (APIs) Report issue

This page summarizes the full range of both experimental and approved interventions. The active ingredients in a medicine (Active Pharmaceutical Ingredients; APIs) include conventional small molecule drugs, vaccines, biologics (based upon recombinant DNA technologies), biologicals (derived from natural products), gene and cell therapies. This information includes the backgrounds of the medicines, clinical trials investigating their safety and efficacy, their intended (& approved) uses, sponsoring organizations, targets and mechanistic basis. We also compare the first FDA approval for any given drug (known as a new molecular entity; NME), from additional (secondary) NDA approvals and approvals for a generic form (known as ANDAs). Please note that since ClinicalTrials.gov is a comparatively recent dataset, the first clinical trial might occur after the approval of established medicines.
api_id earliest_year trade_api_name Active Pharmaceutical Ingredient Clinical Trial Years Total Trials Max Phase Lead Sponsors Approval Status API Type

Note: these approvals are sourced from Drugs@FDA and Purple Book, and do not currently reflect older FDA approvals and/or other evidence of US marketing.

api_id earliest_year trade_api_name sponsor_org_id Active Pharmaceutical Ingredient Earliest NDA Sponsor Approval Years Innovator Approvals Generics Approvals Approval Status API Type