Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board)
Dihexa: Regulatory Status
Current legal and regulatory status for Dihexa across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Dihexa overviewUnited States
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Research Only
Compounding status: not specifically addressed by FDA. WADA: not listed. no regulatory approval; no clinical trials registered; research compound only
Last verified:
What This Means
Reclassification is not the same as FDA approval.
Even if Dihexa moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.