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FDA tracker

Tesamorelin: FDA regulatory status

FDA approvedUpdated Apr 23, 2026

FDA approved 2010 (HIV-lipodystrophy)

Editorially reviewedThe Peptide Examiner editorial team, Editorial review · Reviewed Apr 23, 2026

Regulatory notes

No peptide-specific FDA regulatory events tracked yet. See the full FDA enforcement timeline for the broader regulatory context.

What this means for patients

Tesamorelin is FDA approved. Access is through a clinician prescription and a licensed pharmacy. Insurance coverage depends on the approved indication and your plan's formulary.