Is Dihexa legal? FDA status and US regulatory standing
Current status
Compounding nomination withdrawn. Dihexa was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists.
Primary source: www.fda.gov
Federal legal status
FDA approval status
Dihexa was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Angiotensin IV-derived hexapeptide (PNB-0408) from WSU research. Cognitive enhancement in animal models. No FDA approval, no NDA or IND. Not on any FDA list. Research compound only.
Also known as
PNB-0408
Frequently asked questions
- Is Dihexa FDA approved?
- Dihexa was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Primary source linked on this page.
- Is Dihexa legal to buy?
- Dihexa is available in the U.S. as a research-use-only compound. It was nominated for the FDA bulk drug substances compounding list and was previously placed in a safety-review category before the nomination was withdrawn, so it does not appear on the current bulk substances lists. Sale for human consumption is not permitted.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .