Is dipeptide diaminobutyroyl benzylamide diacetate FDA-approved, and what does the research show?

What is dipeptide diaminobutyroyl benzylamide diacetate?

Dipeptide diaminobutyroyl benzylamide diacetate is a synthetic peptide, a short chain of amino acids made in a laboratory ¹. Its name says dipeptide, but the maker's page calls it a tripeptide, a chain of three amino acids ¹. The maker gives its molecular weight as below 500 daltons, a unit of molecular mass that marks it as very small ¹. The maker, dsm-firmenich, sells it to cosmetic companies under the trade name SYN-AKE, as a solution in glycerin and water ¹.

Its design copies the working part of Waglerin-1, one of a family of peptides found in the venom of the temple viper, Tropidolaemus wagleri ¹,². In the snake, waglerins are neurotoxins; the cosmetic ingredient is a synthetic mimic of part of Waglerin-1 ²,¹.

Is dipeptide diaminobutyroyl benzylamide diacetate FDA-approved?

No. FDA approves no cosmetic ingredient before sale, apart from color additives ³. FDA's page on its authority over cosmetics, current as of November 18, 2025, says that "the law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market" ³. The same page says that companies that make or market cosmetics "have a legal responsibility to ensure the safety of their products" ³. Drugs@FDA, FDA's database of approved drugs, lists no approved product containing dipeptide diaminobutyroyl benzylamide diacetate or SYN-AKE as of November 9, 2026 ⁴.

FDA decides whether a product is a cosmetic or a drug from its intended use, read from the claims made for it, its reputation and what it contains ⁸. An article "intended to affect the structure or any function of the body" is a drug ⁸. FDA's page on anti-aging products, current as of February 25, 2022, draws the line for wrinkle products ⁹. A product intended "to remove wrinkles or increase the skin's production of collagen" is a drug or a medical device ⁹. One intended "to make lines and wrinkles less noticeable, simply by moisturizing the skin" is a cosmetic ⁹.

Since the Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, FDA can order a recall ¹⁰. 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" ¹⁰. MoCRA also requires the responsible company to report serious adverse events to FDA within 15 business days and to keep records that substantiate the safety of its products ¹⁰. So nobody at FDA has reviewed a serum carrying this peptide for safety or effectiveness before it is sold ³,¹⁰. The company that makes or sells the product carries that duty ³,¹⁰.

See the FDA status of every peptide, updated weekly.

How does dipeptide diaminobutyroyl benzylamide diacetate work?

The proposed mechanism is the venom peptide's. In the maker's account, the peptide is "an antagonist at the muscular nicotinic acetylcholine receptor," the receptor on a muscle fiber that receives the nerve's signal to contract ¹. With those receptors blocked, the maker says, "facial muscles are relaxed," and the lines that facial movement makes would soften ¹.

The maker reports this as a laboratory finding ¹¹. In a culture of nerve-connected muscle cells, the peptide at 0.5 millimolar, a laboratory concentration, reduced the frequency of contractions, an effect the company calls reversible ¹¹. Those are the company's figures, not an independent study's.

The authors of a 2026 serum study describe the peptide as working "similarly to" botulinum toxin "by blocking signal transduction and relaxing the muscles in the treated area" ⁶. They add that published research on its anti-wrinkle effects is limited ⁶. No published study measuring how much of the peptide passes through intact skin to the muscle beneath was found on November 10, 2026.

What does the research show?

Studied in people: one randomized, placebo-controlled trial in Texas enrolled 57 women aged 50 to 65 for four weeks ⁵. The trial was double-blind, so neither the women nor the assessors knew who had the placebo cream, a cream with no active ingredient ⁵. Twenty-eight used the placebo cream and 29 the active cream, twice a day on the whole face ⁵.

The active cream held 4 percent of the maker's solution, so about 0.01 percent of the peptide ⁵. After four weeks, frown lines on the forehead and between the brows were 13.5 percent smaller in area and 14 percent shorter than in the placebo group ⁵. The measurement was taken from photographs of an angry expression ⁵.

Smile lines at the corners of the mouth did not change significantly against placebo ⁵. On a skin-surface scan, crow's feet did not change significantly from baseline at four weeks, and expert graders found the same improvement on placebo as on the active cream ⁵. The authors were affiliated with the maker and with two contract firms ⁵.

A second study with three of the same authors measured facial skin color, not wrinkles, in women living in Thailand ⁷. Among 54 Asian women, one group applied an anti-aging emulsion and the other a vehicle, a base with no active ingredient, twice a day for 28 days ⁷. Afterward, skin in the emulsion group was lighter on the upper cheek and less red overall, and the vehicle group showed no statistically relevant color change ⁷. Two of its authors were employees of the maker, "the manufacturer of the anti‐ageing peptide tested in the study," and the wrinkle trial's paper identifies that peptide as this one ⁷,⁵.

The other two studies cited here are of a five-ingredient serum, not of the peptide alone. In 2026, L'Oréal scientists reported two single-arm studies in China of a serum holding this peptide, acetyl hexapeptide-8, gluconolactone, niacinamide and a seaweed extract ⁶. The entry criteria were Chinese women aged 25 to 55 who used anti-aging serums and had dermatologist-graded wrinkles ⁶. Fifty women completed a 12-week study of static wrinkles, the ones present when the face is at rest, and 42 completed an eight-week study of expression wrinkles ⁶. Dermatologists' scores improved against baseline by 35 to 69 percent for static wrinkles and by 10 to 13 percent for expression wrinkles ⁶.

With no control group, the authors write, the results may not "adequately account for potential confounders" ⁶. Nor can a single-arm study of five actives show which ingredient produced the change. The maker's own test, with a placebo group and 15 volunteers per group, reports "up to 52% wrinkle reduction after 28 days" on the forehead with 4 percent SYN-AKE; those are the company's figures ¹¹. None of the studies cited here reports enrolling men, and none lasted beyond 12 weeks.

What are the side effects?

The published safety record is thin. In the serum studies, "no adverse events were reported in any of the clinical studies" ⁶. Ninety-two women completed the clinical evaluations, and 115 used the serum in all, with no adverse events reported, though the serum held four other actives ⁶. The four-week randomized trial of the peptide alone does not report whether any skin reactions occurred ⁵.

The maker calls the ingredient "safe for topical applications" but publishes no irritation or sensitization data on its product page or in its brochure ¹,¹¹. The Cosmetic Ingredient Review, an expert panel funded by the cosmetics industry's trade association, had published no safety assessment of it as of November 10, 2026 ¹². No published report of a toxic effect from it on skin was found on November 10, 2026. Serious reactions to a cosmetic can be reported to FDA, and FDA's MoCRA page links to its page on reporting a cosmetic complaint ¹⁰.

In sport

Dipeptide diaminobutyroyl benzylamide diacetate is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency, under its chemical name or as SYN-AKE ¹³.

What JumpstartMD offers

JumpstartMD does not prescribe dipeptide diaminobutyroyl benzylamide diacetate. 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.