Regulatory status

Status at a glance

503A compounding status

Not nominated

We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.

Status recorded · FDA source document

FDA approval
Not FDA-approved for any use
503B outsourcing
Not determined
Anti-doping (WADA)
Not on the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.

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Status as of

Key takeaway

Palmitoyl tripeptide-1 is a fat-attached "signal" peptide based on a natural collagen fragment, best known as one half of the popular Matrixyl 3000 blend. Laboratory work suggests it signals skin cells to make more collagen and other matrix proteins, which is the basis for its use in products aimed at the appearance of firmness and fewer wrinkles. As of 2026, the support is mostly laboratory and manufacturer data, with no independent human trial of the ingredient on its own.

At a glance

What it is
Cosmetic ingredient, a collagen-inspired signal peptide (part of Matrixyl 3000)
FDA status
Does not require FDA approval, as a cosmetic ingredient rather than a drug
Research
Activity rests on laboratory and manufacturer data; independent single-ingredient human evidence is lacking
Used in
"Anti-aging" products for the look of firmness and fine lines
Evidence strength
Low research

Summary

Palmitoyl tripeptide-1 is a cosmetic collagen-signal peptide in Matrixyl 3000. Learn how it works, what the evidence shows, and its regulatory status.

What is palmitoyl tripeptide-1?

Palmitoyl tripeptide-1 is a peptide of three amino acids (glycine, histidine, and lysine) joined to palmitic acid, a fatty acid added to help the peptide pass into skin. The peptide portion is a natural fragment released from collagen, so it acts as a familiar signal to skin cells. It is made by Sederma and is one of the two active peptides in the widely used Matrixyl 3000 blend. It is a cosmetic ingredient, not a drug.

How does it work?

Laboratory studies describe palmitoyl tripeptide-1 as a matrikine, a peptide that signals skin cells to rebuild support structures. In cell models it is reported to prompt dermal fibroblasts to produce more collagen (types I and III) and fibronectin, the proteins that keep skin looking firm and smooth. The attached fatty acid is included to improve how well the peptide penetrates the skin surface.

These are laboratory and manufacturer findings about how the peptide behaves, not proof of a clinical result. In finished cosmetics the benefit is described in appearance terms, such as the look of firmer skin and reduced fine lines.

Is it FDA-approved?

Safety note

Status: Does not require FDA approval, as a cosmetic ingredient rather than a drug

Category: Cosmetic and topical · Primary body area: Skin & aging

No, and it does not need to be. The FDA does not pre-approve cosmetic ingredients. A cosmetic may describe effects on the look and feel of skin, while a claim to rebuild the body's collagen would make a product a drug. Palmitoyl tripeptide-1 is used within the cosmetic boundary, for the appearance of the skin.

What is it used for?

Palmitoyl tripeptide-1 is used in "anti-aging" serums and creams, almost always alongside palmitoyl tetrapeptide-7 as the Matrixyl 3000 pairing. The appearance goals are the look of firmer, plumper skin and a reduction in the appearance of fine lines and wrinkles.

What does the research show?

Editor’s note

Evidence strength: Low research

Support rests on laboratory and manufacturer data plus a confounded multi-peptide study, with no sound independent human trial of the ingredient by itself.

The direct human evidence is limited:

  • According to PubMed, the peptide appears in a human study of a multi-peptide eye serum that reported appearance benefits, but because many peptides were combined, the effect cannot be attributed to palmitoyl tripeptide-1 alone.
  • Most of the specific efficacy data come from manufacturer in-use panels.
  • An independent review notes that collagen-fragment peptides like this one penetrate skin poorly, which is a relevant real-world limitation.
  • There is no independent single-ingredient human trial.

What are the side effects?

Palmitoyl tripeptide-1 is generally considered well tolerated on the skin, with low irritation potential at cosmetic use levels. As with any new product, a patch test is reasonable for sensitive or reactive skin, since individual responses vary.

Sources: a clinical study of a multi-peptide eye serum (Li et al., Journal of Cosmetic Dermatology, 2023, DOI: 10.1111/jocd.15849); and a review of peptide skin permeability (Mortazavi and Moghimi, International Journal of Cosmetic Science, 2022, DOI: 10.1111/ics.12770), both indexed on PubMed. This document is educational and does not constitute medical advice.

Registered human trials

0 registered human trials on ClinicalTrials.gov that we reviewed

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