Reviewed by Peptide Treatments Medical Advisory Board (Medical Advisory Board)
Tirzepatide: Regulatory Status
Current legal and regulatory status for Tirzepatide across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Tirzepatide overviewUnited States
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FDA Approved
Prescription required
Recent Regulatory Action
FDA approved Zepbound for obstructive sleep apnea in adults with obesity (January 2025).
FDA-approved as Mounjaro (T2D, 2022) and Zepbound (chronic weight management, 2023). Dual GIP/GLP-1 receptor agonist, first-in-class.
FDA Pathway: NDA 215866 (Mounjaro), NDA 217806 (Zepbound)
Last verified:
What This Means
Reclassification is not the same as FDA approval.
Even if Tirzepatide 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.