Regulatory record
- April 2026
- The nomination is withdrawn by its nominators and dihexa acetate leaves Category 2 of the interim 503A bulks list without being added to Category 1; it appears in no category of the list FDA published on May 14, 2026.
- August 2026
- FDA continues to publish its finding for the substance: it has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration, and it lacks important information regarding any safety issues raised by the substance, including whether it would cause harm if administered to humans.
- FDA final action
- None as of August 2026.
Status verified for this index · August 2026
Definition
Dihexa is a synthetic derivative of angiotensin IV, built to survive in the body long enough to reach the brain. It was developed in an academic laboratory as a candidate for dementia, and its proposed mechanism is not receptor agonism in the usual sense: it acts through the hepatocyte growth factor and c-Met system to promote synapse formation [1][2].
It is sold today as a nootropic. The gap between a metabolically stabilized angiotensin IV analogue designed for Alzheimer's disease research and a cognitive-enhancement product is the subject of this page.
Evidence
The preclinical record is genuine and small. The founding work evaluated metabolically stabilized angiotensin IV analogues as procognitive agents and identified this compound among them [1]; a follow-up established that the procognitive and synaptogenic effects depend on activation of the hepatocyte growth factor and c-Met system [2]; a 2021 study reported recovery of memory in a transgenic mouse model of Alzheimer's disease [3].
The human record does not exist. Across three name variants PubMed returns 18 indexed records in total, of which 9 carry the Humans subject heading, 0 the clinical-trial publication type, and 0 the randomized-controlled-trial type [4]. Eighteen records is the entire indexed literature for this compound, and the Humans-tagged nine are receptor and pathway work rather than administration to people.
FDA states the same thing from its own vantage point, and states it more starkly: it has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration [5]. Two instruments looking from opposite directions — a bibliographic census and a regulatory review — return the same answer, which is a stronger form of an absence claim than either produces alone.
Lawful access
There is no lawful United States supply route. Dihexa acetate was in Category 2 of FDA's interim section 503A bulks list and left it in April 2026 when the nomination was withdrawn by its nominators; it was not added to Category 1 and appears in no category of the list FDA published on May 14, 2026 [6].
The finding attached to it was never retracted. FDA continues to publish it: the agency lacks important information regarding any safety issues raised by dihexa acetate, including whether it would cause harm if administered to humans [5]. That is a different sentence from a finding of danger, and this index does not upgrade it into one. It is a statement that nobody knows, made by the body whose job it is to know.
Material sold under this name is research-use-only chemical supply, produced and sold outside pharmacy licensure, prescriber oversight, and pharmaceutical quality standards. The research-only page sets out what that position means for a buyer.
Elsewhere in this index
Filed under
- Research-onlyNo lawful route
- Neuropeptides5 molecules in this class
- The molecule indexEvery molecule, filterable by status and class
Reference tables
- The 2026 recordWhat happened to United States peptide compounding law in 2026, in order?
- The nomination trackerWhat became of each peptide's nomination to the 503A bulks list?
- The human trial recordHow many human clinical trials exist for each peptide in this index?
Same class
- SemaxPCAC-recommended · pending
- DSIPNo lawful route
- Kisspeptin-10No lawful route
- SelankNomination withdrawn
References
- McCoy AT, Benoist CC, Wright JW, et al. Evaluation of metabolically stabilized angiotensin IV analogs as procognitive/antidementia agents. J Pharmacol Exp Ther. 2013;344(1):141–154. PMID 23055539
- Benoist CC, Kawas LH, Zhu M, et al. The procognitive and synaptogenic effects of angiotensin IV-derived peptides are dependent on activation of the hepatocyte growth factor/c-met system. J Pharmacol Exp Ther. 2014;351(2):390–402. PMID 25187433
- Sun X, Deng Y, Fu X, et al. AngIV-Analog Dihexa Rescues Cognitive Impairment and Recovers Memory in the APP/PS1 Mouse via the PI3K/AKT Signaling Pathway. Brain Sci. 2021;11(11). PMID 34827486
- PubMed, National Library of Medicine. Census run 2026-08-31 across three name variants — "dihexa" OR "PNB-0408" OR "N-hexanoic-Tyr-Ile-(6) aminohexanoic amide" — returning 18 indexed records in total, 9 carrying the Humans MeSH term, 0 under "clinical trial"[Publication Type] and 0 under "randomized controlled trial"[Publication Type]. There is therefore no trial-type record to read. The publication-type filter was proved live in the same run against a control term returning 8,904 records under the clinical-trial type and 6,113 under the randomized type; the invalid tag clinicaltrial[pt] returned 0 for that control term in the same run, and a deliberately invalid record identifier errored in the same run. Source
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, content current as of April 22, 2026, entry for Dihexa acetate in the table of substances nominated but withdrawn. Read 2026-08-31. Source
- US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Read in full 2026-08-31: dihexa appears in none of Category 1, Category 2, or Category 3. Source