Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 10, 2026.
FDA status
Not approved
Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.
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Evidence tier
Animal Only. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 1/5. 45 PubMed citations indexed.
Products sold as "research use only" are not approved for human use. FDA warning.
Angiotensin IV analog and HGF activator that potently promotes synaptogenesis via c-Met receptor activation; described as >7 orders of magnitude more potent than BDNF in animal models.
What the literature studies
Cognitive Enhancement & Memory
Evidence tier
Animal Only
Compounding record
Status not verified
Status not verified. Status not verified. Exact FDA substance context: Dihexa acetate: Nomination withdrawn. The record does not specify acetate; do not extrapolate to other salts or analogs. Previously in Category 2; FDA still identifies potential significant safety risks for the named withdrawn substance. Withdrawal is not FDA approval or a determination of safety or compounding eligibility. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source checked October 10, 2026. This compounding label is separate from the approval line above.
Entirely preclinical; no human trials published; potential oncogenic risk given potent HGF/c-Met pathway activation.
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Dihexa is an angiotensin IV-derived research peptide with no identified human clinical exposure data; FDA lists dihexa acetate among nominated-but-withdrawn compounding substances, and a prominent 2014 JPET paper on its procognitive effects was retracted in 2025 for fabricated/falsified data.
An orally active angiotensin IV analog researched as a potential cognitive enhancer via hepatocyte growth factor / c-Met pathway claims in preclinical literature [FDA-RISK].
Not FDA-approved. FDA lists Dihexa acetate under "nominated but withdrawn" compounding substances and states it has not identified any human exposure data via any route and lacks information needed to know whether the drug would cause harm if administered to humans [FDA-RISK].
None identified. FDA explicitly states no human exposure data for dihexa acetate products [FDA-RISK].
Preclinical papers previously claimed synaptogenic/procognitive effects. The widely cited Benoist et al. JPET 2014 paper (PMID 25187433) was retracted in 2025 after findings of falsified or fabricated data [R1]. Remaining animal literature is therefore thinner and should not be treated as established proof of human benefit.
Unknown human safety. FDA: insufficient information to assess harm [FDA-RISK]. Gray-market products: identity and purity unverified. Do not rely on retracted literature.
No FDA approval pathway identified. Any future clinical claims would need new, unretracted primary evidence.
Last checked 2026-10-27
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