FDA-approved product exists

Tirzepatide

FDA-approved

Tirzepatide has FDA-approved prescription products (MOUNJARO / MOUNJARO (AUTOINJECTOR) / MOUNJARO KWIKPEN (NDA215866), ZEPBOUND / ZEPBOUND (AUTOINJECTOR) / ZEPBOUND KWIKPEN (NDA217806)). Tirzepatide is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 50 registered ClinicalTrials.gov studies cite Tirzepatide (20 completed, 12 recruiting, 10 not yet recruiting, 5 active not recruiting, 2 enrolling by invitation, 1 unknown); registration is not evidence of approval, efficacy, or safety. CompoundedGuide is verifying compounding status, safety signals, and current evidence. This is not medical advice.

What we've verified

Product status: FDA-approved: MOUNJARO / MOUNJARO (AUTOINJECTOR) / MOUNJARO KWIKPEN (NDA215866), ZEPBOUND / ZEPBOUND (AUTOINJECTOR) / ZEPBOUND KWIKPEN (NDA217806)
Still checking: Compounding status, shortage status, safety signals

Verified sources

openFDA Drugs@FDA P0 · retrieved 2026-07-25
503B Bulks List and Interim Categories P0 · retrieved 2026-07-25
ClinicalTrials.gov API v2 P0 · retrieved 2026-07-25

Research and evidence

FDA-approved product exists cite Tirzepatide. Registration is not evidence of approval, efficacy, or safety.

Browse every trial and publication for Tirzepatide →

For developers

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