Argireline (acetyl hexapeptide-8)

Also known as: acetyl hexapeptide-3

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 3 of 47 publications on PubMed
Registered clinical trials 7 0 active
Adverse event reports 0 0 classified as serious
  • Argireline (acetyl hexapeptide-8) is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 47 publications mentioning it, including 3 randomized controlled trials and 3 animal-only studies.
  • ClinicalTrials.gov lists 7 registered studies testing it (0 active).
  • FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

  • Skin Aging 19
  • Skin 15
  • Administration, Cutaneous 9
  • Skin Absorption 7
  • Cosmetics 6
  • Administration, Topical 5
  • Botulinum Toxins, Type A 4
  • Cosmeceuticals 3
  • Cosmetic Techniques 3
  • Drug Delivery Systems 3

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 47
  • Human (MeSH) 29
  • Animal only 3
  • Clinical trials 3
  • Randomized controlled trials 3
  • Systematic reviews & meta-analyses 1
  • Case reports 1
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
7
Active
0
With posted results
2

Conditions studied

  • Focal Dystonia 2
  • Photoaging 1
  • Skin Aging 1
  • Periorbital Area 1
  • Skin Care 1
  • Oily Skin 1
  • Wrinkles 1
Study Status Phase Start
AI-Personalized Skincare Regimen for Facial Photoaging in Women
NCT07879833 MDalgorithms Inc.
Completed N/A September 30, 2025
A Clinical Trial to Evaluate the Effects of an Eye Serum on Improving the Appearance of the Periorbital Area
NCT06143033 Dime Beauty Co.
Completed N/A August 21, 2023
Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream
NCT03878381 Wayne State University
Completed Early phase 1 April 1, 2019
Topical Acetyl Hexapeptide-8 and the Cosmetic Appearance of Oily Skin
NCT02597777 University of California, Davis
Completed N/A Jan 2016
Acetyl Hexapeptide-8 for Blepharospasm
NCT01750346 National Institute of Neurological Disorders and Stroke (NINDS) Results posted
Terminated Phase 2 Nov 2012
A Study of Acetyl Hexapeptide-8 (AH8) in Treatment of Blepharospasm
NCT00942851 National Institute of Neurological Disorders and Stroke (NINDS) Results posted
Completed Phase 1, Phase 2 Jul 2009
Argireline in Treatment of Periorbital Wrinkles
NCT01381484 Mahidol University
Completed Phase 3 Mar 2009

All 7 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

No FAERS reports mention this peptide.

Source: FDA FAERS · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.