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PeptideFactSheets

Keep the jargon on a short leash

The peptide glossary

Plain-English definitions for the regulatory, trial, safety, and biology terms that show up across peptide research pages.

Adverse event

An unwanted medical occurrence during a study or treatment. It may or may not have been caused by the product.

Agonist

A substance that activates a receptor and produces a biological response.

Amino acid

A small molecule used as a building block for peptides and proteins.

Analog

A modified version of a natural or existing molecule, designed to keep or change certain properties.

Boxed warning

A prominent warning in prescription-drug labeling for especially serious safety risks.

Clinical hold

An FDA order that delays or stops a clinical trial until the sponsor addresses a safety or information concern.

Clinical trial

A planned study in people designed to answer defined questions about an intervention, outcome, or observation.

Contraindication

A situation in which a product should not be used because the risk is too high.

Discontinued

A product or development program has stopped. Discontinuation can reflect business, manufacturing, safety, efficacy, or other reasons, so the source matters.

Endpoint

A result a study is designed to measure, such as a symptom score, lab value, event, or survival.

FDA approval

A regulatory decision for a specific product and use after review of evidence, manufacturing, and labeling.

FDA label

The FDA-reviewed prescribing information for a drug product, including approved uses, limits, warnings, and other required details.

Half-life

The time it takes for the amount of a substance in the body to fall by about half.

Hormone

A chemical messenger made in one place that can affect cells elsewhere in the body.

Investigational drug

A drug being studied that has not been FDA approved for routine marketing for the proposed use.

Off-label use

Use of an FDA-approved medicine in a way not described in its approved label. It is not the same as an FDA-approved use.

Peptide

A chain of amino acids, generally shorter than a protein, that may have signaling, structural, or other biological roles.

Phase 1

An early human study phase that usually asks first safety, tolerability, and body-handling questions.

Phase 2

A human study phase that explores whether a signal holds up in the target condition and helps refine later trial design.

Phase 3

A larger confirmatory study phase intended to test benefits and harms in the population a sponsor may seek to label.

Phase 4

Post-approval research or monitoring that studies a product after it is already on the market for an approved use.

Placebo

An inactive comparison designed to resemble the study intervention, helping researchers separate treatment effects from expectations and other changes.

Primary endpoint

The main result a trial is designed to evaluate. Secondary or exploratory findings should not be treated as equally decisive.

Receptor

A cellular structure that receives a chemical signal and helps trigger a response.

Surrogate endpoint

A marker such as a lab value or imaging measure used as a stand-in for a clinical outcome. It may or may not predict how people feel, function, or survive.

Topline results

A brief sponsor summary of key findings, often released before full peer-reviewed data are available.

Trial registration

A public study record that describes a planned or ongoing trial. Registration is not the same as a favorable result.

Sources for these definitions

Definitions are simplified for readers. Use the official source records for the full regulatory or registry meaning in a particular context.

  1. 1
    fdaFDA: prescription-drug labeling questions and answers

    Primary FDA explanation of prescribing information, boxed warnings, and other label sections.

  2. 2
    clinical trialsClinicalTrials.gov: how to read a study record

    Official guide to registry fields, including status, phases, endpoints, results, and record history.

  3. 3
    nihNIH: clinical trials and you — the basics

    NIH overview of clinical research and the purpose of common trial phases.