Hexarelin: Regulatory Status
Current legal and regulatory status for Hexarelin across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Hexarelin overviewUnited States
Compoundable (503A)
Prescription required
Compounding status: available through research peptide suppliers. WADA: prohibited (S2 — peptide hormones, growth factors). reached Phase 2 clinical trials but development discontinued; no regulatory approval in any jurisdiction
What This Means
Compoundable does not mean FDA approved.
Hexarelin is available through licensed 503A compounding pharmacies with a physician's prescription. This is a regulatory pathway, not an endorsement of efficacy for any specific indication. All use is off-label.
Reclassification is not the same as FDA approval.
Even if Hexarelin 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.