Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board)
Tesamorelin: Regulatory Status
Current legal and regulatory status for Tesamorelin across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Tesamorelin overviewUnited States
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FDA Approved
Prescription required
FDA-approved as Egrifta (2010) and Egrifta SV (2019) for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. The only FDA-approved GHRH analog. Off-label use for body composition requires physician supervision.
FDA Pathway: NDA 022505 (Egrifta), NDA 208379 (Egrifta SV)
Last verified:
What This Means
Reclassification is not the same as FDA approval.
Even if Tesamorelin 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.