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Research & insights

MOTS-c “Human”: What the Label Means, and What FDA Says Is Still Missing

By NHD Technical TeamPublished
Conceptual illustration of a peptide sequence label and a human evidence gap
Article-specific editorial image.

“Human” in a MOTS-c catalog title ordinarily describes the referenced peptide sequence; it does not mean the material was isolated from a human donor, tested in humans or approved for human use.

What the record shows

  • The core efficacy literature remains cell- and animal-based.
  • FDA says it has not identified human exposure data for drug products containing MOTS-c.
  • The word “human” must not be presented as a clinical-use signal.
Scientist reviewing mitochondrial membrane imaging and energy-metabolism data
Original editorial illustration used to identify the research theme. It does not depict a catalog lot, approved drug, assay result or clinical use.

The identity and evidence boundary

Mitochondrial genetic notation is unusually easy to oversimplify. The sequence should be stated directly, with any terminal modification or counterion, rather than relying on the word “human.”

“Human” qualifierSequence reference, not intended-use permission
FDA human exposure findingNo identified human exposure data for MOTS-c drug products
Research documentationSequence, mass, purity, content, aggregation and lot records

What belongs in the material record

FDA also identifies immunogenicity, impurity and API-characterization concerns. Those gaps are reasons to narrow claims, not to fill them with anecdotes.

Editorial rule

Use the exact intervention name, model, population and endpoint from the cited record. Do not convert an association, mechanism, animal result, approved finished-drug record or analytical test into a claim about an unrelated catalog lot.

Sources & editorial method

The editorial workflow starts with linked peer-reviewed papers, trial registries or regulatory records; extracts the population or model, endpoints, numerical results and limitations; and separates the studied intervention from catalog material. AI-assisted drafting was used to structure the first version. Claims, figures, evidence labels and limitations were checked against the linked records in the site editorial workflow. This is not independent peer review.

3 linked records are listed in the references below. Read the editorial and AI-assistance policy.

How to interpret this article

Source-checked on 2026-08-28. Null findings and study limitations are retained. This is not independent peer review, medical advice, a customer case, or validation of a catalog lot.

Research-use boundary: Catalog materials discussed on this website are for laboratory research, development and manufacturing use only, not for human or veterinary use. This content is not medical advice and does not provide administration instructions.

Primary records and authoritative sources

  1. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasisLee C, et al. Cell Metabolism. 2015. PMID 25738453.
  2. Review of mitochondrial-derived peptides in energy metabolismEvidence-context review; PMID 32776825.
  3. Certain Bulk Drug Substances That May Present Significant Safety RisksU.S. FDA. Current compounding safety-information page.
Research pathways

Continue with structured records

Move from this editorial analysis to the product identity, filtered evidence and controlled terminology behind it.

Editorial source check: NHD evidence editorial workflow · 2026-08-28