Is palmitoyl tripeptide-38 FDA-approved, and what does the research show?

What is palmitoyl tripeptide-38?

Palmitoyl tripeptide-38 is a synthetic peptide made for skin creams and serums. The Cosmetic Ingredient Review, an expert panel that assesses cosmetic ingredients, defines it as "the reaction product of palmitic acid and Tripeptide-38" ¹. Tripeptide-38 is, in the panel's words, "a three-residue synthetic peptide containing lysine and methionine" ¹.

Palmitic acid is a fatty acid, so the molecule is a lipopeptide, a peptide with a fat tail. The 2020 study gives its structure as palmitoyl-lysyl-dioxymethionyl-lysine and calls it a "matrikine-mimetic peptide" ². A matrikine is a fragment of a skin-matrix protein that acts as a signal to skin cells, and this peptide is built to imitate one ².

Cosmetic makers list it as a skin-conditioning agent, and companies reported using it to FDA's voluntary cosmetic registration program in 2012 ¹. Croda, the maker, now sells it as Matrixyl synthe'6, a blend of glycerin, water, hydroxypropyl cyclodextrin and the peptide ³.

Is palmitoyl tripeptide-38 FDA-approved?

No. FDA approves no cosmetic ingredient before sale except color additives ⁴. Its page on its authority over cosmetics, current as of November 18, 2025, puts it this way: cosmetic "products and ingredients do not need FDA premarket approval, with the exception of color additives" ⁴. The same page says that "neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients" ⁴. The companies that make or market a cosmetic "have a legal responsibility" for its safety ⁴.

FDA can act against a product on the market that breaks the law ⁴. Since the Modernization of Cosmetics Regulation Act of 2022, "FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily" ⁸.

Palmitoyl tripeptide-38 is also not FDA-approved as a drug: Drugs@FDA, FDA's database of approved drug products, lists no approved palmitoyl tripeptide-38 product as of November 9, 2026 ⁵. FDA sorts a product as a cosmetic or a drug by its intended use ⁹. It reads that use from what the label and advertising claim, what consumers take the product to be, and what it contains ⁹. The law's drug definition covers articles "intended to affect the structure or any function of the body" ⁹.

FDA's page on anti-aging products, current as of February 25, 2022, draws the line at the claim ¹⁰. A product intended "to remove wrinkles or increase the skin's production of collagen" is a drug or a medical device ¹⁰. One intended "to make lines and wrinkles less noticeable, simply by moisturizing the skin" is a cosmetic ¹⁰. A serum carrying this peptide therefore comes to market with no FDA review of its safety or effectiveness, and its maker, not FDA, carries the legal responsibility for its safety ⁴.

See the FDA status of every peptide, updated weekly.

How does palmitoyl tripeptide-38 work?

The mechanism is proposed, not shown in people. The 2020 paper cites laboratory experiments in cells and on pieces of human skin kept alive outside the body ². In those cited experiments the peptide was shown "to stimulate the synthesis of six matrix molecules including collagen I, III, and IV, hyaluronic acid, fibronectin, and laminin" ². Its source for them is a European patent, not a journal paper ². The skin matrix is the scaffold of proteins and sugars between skin cells that gives skin its firmness.

Whether enough of the peptide crosses intact skin to reach the deeper layers has not been measured in people in any paper found. Studied in cells: a serum of the peptide with apple stem cell extract, urea and creatine raised oxygen consumption and energy stores in aged human skin cells ⁶. That result belongs to the whole serum, not the peptide ⁶.

What does the research show?

Studied in people: one open-label study, published online in October 2020, enrolled 35 women aged 49 to 74 with visible photoaging ². Their mean age was 64, and all had Fitzpatrick skin types II or III, the lighter types on a six-step scale ². Open-label means that everyone knew what they were using and nobody got a placebo.

The women applied a serum once a day for 56 days ². It held 15 percent L-ascorbic acid, which is vitamin C, tocopheryl acetate, a form of vitamin E, and 5 parts per million of palmitoyl tripeptide-38 ². The study tested that serum, not the peptide alone, and its authors say so: without testing "all seven permutations" they could not separate the three ingredients' contributions ².

By a three-dimensional skin-surface camera, measures of skin roughness and wrinkle relief around the eyes fell by a mean of 8 to 9 percent at day 28 ². Photographic analysis at day 56 found a 9 percent decrease in redness and "an increase of 8% in the ITA angle indicating decreased pigmentation" ². The study was funded by Alumier MD Laboratories, the maker of the serum, and all three authors are consultants to the company ². The paper also cites "a randomized vehicle-controlled clinical trial of the peptide" at 5 parts per million ². Its source for that trial is a trade-magazine article, not a published trial ².

Two more open-label studies tested products that contained the peptide among several active ingredients. In a 2015 study, 32 women with sensitive skin and crow's feet wrinkles used a serum twice daily for 28 days ⁶. Five of the study's seven authors work for the serum's maker ⁶. It held apple stem cell extract, urea, creatine and the peptide, and the authors report an anti-wrinkle effect in 71 percent of the women ⁶.

In another 2015 study, 37 women aged 35 to 60 completed 12 weeks of twice-daily use of a moisturizer ⁷. It held a peptide blend, plant extracts and a vitamin C derivative, and clinical grading improved from baseline ⁷. Neither study can say what the peptide itself did. No randomized or controlled trial of palmitoyl tripeptide-38 on its own was found in PubMed on November 10, 2026, and no study has followed users beyond 12 weeks.

What are the side effects?

In the 2020 serum study of 35 women, the authors wrote that "the product was well tolerated, and no adverse effects attributed to the serum were observed" ². In the 2015 moisturizer study of 37 women, the product was "judged to be mild and well tolerated," with no significant rise in any tolerability score over 12 weeks ⁷. Both findings belong to a finished product with several active ingredients, not to the peptide alone.

The Cosmetic Ingredient Review's panel has published no safety conclusion on palmitoyl tripeptide-38. In March 2013 it tabled a draft report on a group of palmitoyl peptides, writing that "the terminology used for these ingredients does not enable adequate evaluation" ¹¹. The panel added that "some small peptides are potent stimulators of angiogenesis," the growth of new blood vessels ¹¹. It set a condition, "If there is a substantial degree of randomness," under which "the potential for such an activity to promote tumor growth and metastasis in people with undiagnosed skin cancer might then be an issue" ¹¹. Metastasis is the spread of a cancer.

Those are the panel's open questions about the group, not findings about this peptide. No published irritation, sensitization or mutagenicity test of the peptide itself was found; the only such data sit in a 2013 draft the panel marked not for citation.

FDA has written no safety words about this ingredient in any page opened, and the law requires no specific safety test of it before sale ⁴. Under the 2022 law, a cosmetic's responsible person is the manufacturer, packer or distributor named on its label ⁸. That person must report serious adverse events to FDA and keep records that support the product's safety ⁸.

In sport

Palmitoyl tripeptide-38 is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency ¹².

What JumpstartMD offers

JumpstartMD does not prescribe palmitoyl tripeptide-38. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Disclaimer

Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.