The "platonic", idealized form of an active pharmaceutical ingredient included in or produced by a currently or previously marketed drug product to contribute to the pharmacological action used to treat a condition. Usually an active moiety, except for prodrugs.

A substance present in a currently or previously marketed drug product that is or becomes pharmacologically active once delivered to patients.

A substance that is not pharmacologically active until covalently modified by endogenous biological activity.

The essential aspect of a substance responsible for its pharmacological activity.

21 CFR 314.108(a):

The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.

A regulated, packaged, and formulated product currently or previously marketed for medical use containing one or more active pharmaceutical ingredients.

Fundamentally, an ingredient in a drug product. Substances are catalogued by the Federal Drug Administration (FDA) and assigned a UNique Ingredient Identifier (UNII). Multiple substances can share the same active moiety. Currently, there are six distinct types of Substances, as defined by the ISO 11238 identification of medical products standard: chemical, protein, nucleic acid, polymer, structurally diverse, and mixture. In addition, FDA defines a "concept" as a collection of names, codes, and relationships, which refer to matter that does not fit the definition of a substance, but is still of research, regulatory, or clinical significance. To ensure comprehensive coverage and avoid ambiguity, NCATS Inxight Drugs includes concepts into its list of Substances.

ISO 11238:

Any matter that has discrete existence, whose origin may be biological, mineral or chemical. Substances can be either single substances or mixture substances. Single substances shall be defined using a minimally sufficient set of data elements divided into five types, chemical, protein, nucleic acid, polymer, and structurally diverse. Substances may be salts, solvates, free acids, free bases, mixtures of related compounds that are either isolated or synthesized together.

A biological component, substance, or process that is modulated by a therapeutic intervention, and is suspected to be the most relevant target for the biological activity associated with the major pharmacological use or proposed indication of the therapeutic intervention.

Substances are classified based on their effect on disease progression for a specific disease or condition.
NCATS Inxight uses the following categories:

Primary

Halts or slows disease progression. Treatment often targets the primary pathology of a disease.

Preventing

Intended to prevent the development of a medical condition.

Palliative

Improves the quality of life by alleviating the associated symptoms, without necessarily affecting the underlying pathology.

Secondary

Treats adverse effects associated with the treatment of a condition.

Diagnostic

A substance used for diagnostic purposes, including disease detection and monitoring of disease progression.

Inactive ingredient

An ingredient of a given formulation (most frequently, an excipient) that does not exhibit pharmacological activity. In this case, a condition is only related to such compound via the formulation used to affect (treat or diagnose) this condition.

Ewy A. Mathé

NCATS/NIH, Division of Preclinical Innovation, IFX Core

Keith Kelleher

NCATS/NIH, Division of Preclinical Innovation, IFX Core

Ajit Jadhav

Pfizer

Noel Southall

AstraZeneca

Ðắc-Trung Nguyễn

Pfizer

Ivan Grishagin

Tyler Peryea

FDA

Updates

• Stitcher and Inxight are now built using these updated data sources:
  • G-SRS, December 2023
  • Drugs - FDA & OB, March 2024
  • ClinicalTrials, March 2024
  • FDA Excipients, March 2024
  • FDA NADA and ANADAs, March 2024
  • DailyMed Rx, March 2024
  • Broad Institute Drug List 2024-03-05

Updates

• Stitcher and Inxight are now built using the G-SRS data from July 2023.
• There is a new dataset from the Fast Response Database (FRDB), available on the Downloads page.

Updates

• Stitcher and Inxight are now built using the G-SRS data from December 2022.
• This Release Notes section is new, and will summarize recent enhancements and fixes.
• There is a new dataset from the Fast Response Database (FRDB), available on the Downloads page.

Fixes

• Previously, the Sequence Search functionality was broken. The problem is fixed.
• Previously, some drug pages may render some cards incorrectly, such as with {cardTitle} instead of the card title, due to associated diseases having some problematic characters. The problem is fixed.
• Previously, the Application fields might not show up depending on the format of the data coming from Stitcher. The problem is fixed.