Is hexapeptide-9 FDA-approved, and what does the research show?

What is hexapeptide-9?

Hexapeptide-9 is a synthetic peptide, a chain of six amino acids made in a laboratory ². Its sequence is glycine, proline, glutamine, glycine, proline, glutamine, written Gly-Pro-Gln-Gly-Pro-Gln, and the 2025 trial paper calls it a collagen peptide ². Collagen is the structural protein that gives skin its firmness. It was designed and patented to strengthen the adhesion between skin cells ².

Ashland sells it to cosmetic makers as Collaxyl ng, a solution of hexapeptide-9 in water and butylene glycol ¹. Hexapeptide-9 is the peptide's INCI name, the standard label name for a cosmetic ingredient ¹. The maker describes it as a "collagen-like peptide" and a matrikine, and says the sequence is found in collagen IV and XVII ¹. A matrikine is a fragment of a structural protein that acts as a signal to skin cells. Those are the maker's words about its own product.

Is hexapeptide-9 FDA-approved?

No, and no cosmetic ingredient other than color additives is approved before sale. FDA's page on its authority over cosmetics, current as of November 18, 2025, says "the law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market" ³. Hexapeptide-9 is not FDA-approved as a drug either: Drugs@FDA lists no approved hexapeptide-9 product as of November 9, 2026 ⁴.

The companies that make or sell a cosmetic "have a legal responsibility to ensure the safety of their products," and the law requires no specific safety tests ³. FDA can act against a cosmetic on the market that breaks the law ³. Since the Modernization of Cosmetics Regulation Act of 2022, where there is "a reasonable probability that a cosmetic is adulterated or misbranded" and the cosmetic "will cause serious adverse health consequences or death," FDA "has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily" ⁶. The responsible person is the manufacturer, packer or distributor whose name appears on the product's label ⁶.

Whether a product is a cosmetic or a drug turns on its intended use ⁷. An article "intended to affect the structure or any function of the body" is a drug under the law ⁷. FDA's page on anti-aging products, current as of February 25, 2022, says "if a product is intended, for example, to remove wrinkles or increase the skin's production of collagen, it's a drug or a medical device" ⁸. A product "intended to make lines and wrinkles less noticeable, simply by moisturizing the skin" is a cosmetic ⁸. Ashland offers Collaxyl for "anti-wrinkle, firming and regenerating" cosmetics, so the claims a finished product makes decide which side of that line it falls on ¹,⁷.

The Cosmetic Ingredient Review is an expert panel funded by the cosmetics industry's trade association; its own about page says its review process is independent of the industry ⁹. A search of its released reports on November 10, 2026, found no safety assessment of hexapeptide-9. No panel assessment setting a safe concentration was found, so the safety data below come from the studies' own authors ²,⁵.

See the FDA status of every peptide, updated weekly.

How does hexapeptide-9 work?

The mechanism is proposed, not shown in people. The inventors designed hexapeptide-9 to enhance "intercellular adhesions and cell adhesion to the ECM," the extracellular matrix, which is the scaffold of proteins between cells ². They suggested it may also raise production of that matrix and of integrins, the receptors cells use to grip it ². Ashland says Collaxyl "promotes extracellular matrix synthesis, dermo-epidermal anchorage, epidermal differentiation and regeneration," the maker's description of its product ¹. That is, the maker says it helps the outer skin bind to the layer beneath and renew itself; no study on the page tests that.

A 2025 delivery study calls it a "signal peptide," one that tells skin cells what to make ⁵. It says the peptide promotes collagen production, cell migration and differentiation, but gives no reference for that sentence ⁵.

Studied in animals for photoaging, skin aging from sun exposure ⁵. In groups of five mice exposed to ultraviolet light for eight weeks, hexapeptide-9 alone and in a blend reduced a marker of oxidative damage and preserved collagen-related measures ⁵. Peptides cross the skin poorly ⁵. The authors built an ionic-liquid carrier they call GALA, a salt that stays liquid and is made from two of the body's own chemicals ⁵. In a laboratory skin model it raised the amount of hexapeptide-9 crossing after 12 hours to 4.79 times that of the peptide in water alone ⁵.

The 2025 trial paper says the peptide's two ends were joined into a ring, called cyclization, to improve its stability and skin penetration ². It cites the authors' company's "internal data" for a stronger effect on collagen ².

What does the research show?

Studied in people: one randomized, double-blind trial in mainland China enrolled 96 adults aged 30 to 55, nearly all women, with crow's feet and forehead wrinkles ². Double-blind means neither the participants nor the investigators knew who used which serum. The trial did not test hexapeptide-9 itself but a cyclized form, CHP-9 ². Participants applied a 0.002 percent CHP-9 serum, a 0.002 percent retinol serum or the serum base alone twice daily for 56 days, and 91 finished ².

Against the base alone, CHP-9 reduced the count of crow's-feet wrinkles by 2.2 on average over the trial ². At day 56 it had reduced their area by 3.95 square millimeters ². The measurements came from a wrinkle-imaging camera ². The 95 percent confidence interval for the count ran from 0.03 to 4.38 fewer, the range within which the true effect most likely lies ².

Forehead wrinkles fell too, and the authors report larger effects than retinol on most measures ². All eight authors, who synthesized CHP-9, list Shanghai Chicmax Cosmetic and Shanghai Kans Biotech as their affiliations, so the trial is the maker's own ². The result is of the cyclized derivative, and the paper gives no human data on hexapeptide-9 itself ².

The only published human test of hexapeptide-9 as such is in a 2025 study of a delivery system ⁵. Ten volunteers had a blend of hexapeptide-9 and the carrier GALA applied to one side of the face and hexapeptide-9 alone to the other ⁵. Within an hour the blend side showed better elasticity and shorter wrinkles, while the hexapeptide-9 side was "comparable to that at the beginning" apart from one elasticity reading ⁵. That is a measurement of minutes, not of lasting change, and the result belongs to the blend ⁵.

A 2023 randomized trial of two facial serums, which a Europe PMC search for hexapeptide-9 returns, was retracted by its journal in January 2026 and is not evidence ¹⁰. The notice says the article "was accepted for publication following an insufficient peer review process," that the study "lacked the formal ethical approval required by U.S. regulations," and that the retraction "does not constitute a finding of research misconduct" ¹⁰. A PubMed search on November 10, 2026, found no published trial of hexapeptide-9 on its own against a placebo over weeks.

What are the side effects?

In the 56-day trial of cyclized hexapeptide-9, investigators checked for redness, swelling, papules (small bumps) and blisters at every visit and reported no treatment-related adverse events in any group ². The authors nonetheless wrote that its long-term safety should be "secured by continuously monitoring" consumer reports of adverse reactions "for at least 3 years" ². In the delivery study, a patch test of the blend on 33 volunteers produced no reaction, and the authors say neither the blend nor hexapeptide-9 induced irritation ⁵. A patch test holds the product against the skin under a dressing to look for a reaction. The ten-volunteer face test reports nothing on adverse effects, and the paper's own limitations name its small sample ⁵.

Those are the only published human safety data on hexapeptide-9 alone or its cyclized form ²,⁵. The trial's authors synthesized CHP-9 and list two companies as their affiliations ². Three of the delivery study's authors list a company, Bloomage Biotechnology, as their affiliation ⁵. None of the sources opened by November 10, 2026, reports how much hexapeptide-9 reaches the bloodstream through skin.

In sport

The 2026 Prohibited List of WADA, the World Anti-Doping Agency, does not name hexapeptide-9 ¹¹. The list has no entry for hexapeptide-9 or Collaxyl under any section ¹¹.

What JumpstartMD offers

JumpstartMD does not prescribe hexapeptide-9. 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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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.