Is tirzepatide FDA approved? Mounjaro, Zepbound and the approval dates

Yes. Tirzepatide is FDA approved as the active ingredient of two Eli Lilly medicines: Mounjaro, first approved on May 13, 2022 under NDA 215866, and Zepbound, first approved on November 8, 2023 under NDA 217806. Both applications have been supplemented since, most recently in August 2026. The approval belongs to those two products; a vial of tirzepatide sold for laboratory research is neither of them. Everything below is as of October 21, 2026.

When was tirzepatide FDA approved?

Tirzepatide's FDA approval date is May 13, 2022, when FDA approved Mounjaro as a new molecular entity under priority review. Zepbound, a second application for the same molecule, followed on November 8, 2023.

Each product's indications are stated in section 1 of its prescribing information, linked under Sources, and is not restated here. Outside the United States, the European Commission authorised Mounjaro on September 15, 2022.

Zepbound vs Mounjaro: what differs on paper?

They share one active ingredient and one sponsor. Everything else that FDA records is separate: the application, the label, the presentations and the supplement history.

Because the indications sit on separate labels, one product's approval does not extend to the other's uses. That is a feature of how FDA approves applications, not of the molecule.

The main FDA actions on tirzepatide, dated

The supplements below are listed in Drugs@FDA with their approval letters. Smaller labeling and manufacturing supplements are left out.

FDA's letter for the August 26 Zepbound action describes it as updates "to add information from a completed cardiovascular outcomes trial"; it is a labeling change, not a new indication.

Is there such a thing as "human-grade" tirzepatide?

Not as a regulatory category. FDA does not grade drugs as "human-grade"; it approves applications. In the United States the only FDA-approved tirzepatide products are Mounjaro and Zepbound, each made at the sites named in its application and released against that application's specification.

Pharmacy-compounded tirzepatide was a temporary exception tied to the shortage. FDA first declared the shortage resolved on October 2, 2024, re-evaluated that decision, and on December 19, 2024 again found it resolved. Its enforcement discretion ended on February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities. FDA's compounder page, current as of April 1, 2026, states that "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list," and on April 30, 2026 FDA proposed excluding tirzepatide from the 503B bulks list; no final decision appears in the Federal Register as of October 21, 2026. The full sequence is in what ended for compounded semaglutide and tirzepatide.

A vial sold as research material is a third thing again: the peptide as a laboratory chemical, with a certificate for its lot and no label for any use in a person. We list tirzepatide on that basis only, and we do not describe it as human-grade, pharmaceutical-grade or equivalent to either approved product.

What does FDA say about research-labelled tirzepatide?

FDA's position, repeated in its warning letters to research-peptide sellers from 2024 to 2026, is that a "research use only" label does not decide what a product is. The letters open with the same formula:

Despite statements on your product labeling marketing your products 'for research use only' and 'not for human or animal consumption,' evidence obtained from your website establishes that your products are intended to be drugs for human use.FDA warning letter, August 24, 2026

The evidence FDA cites is the seller's own text and what it sells alongside the vial. How that reading works, and what this site does not publish because of it, is set out in what FDA reads before calling a research product a drug.

The molecule behind both products

Tirzepatide is a 39-residue synthetic peptide carrying a fatty diacid side chain, designed to bind both the GIP and GLP-1 receptors. Its structure is in the tirzepatide research reference, what a lot certificate for it should show is in how to read a tirzepatide certificate, and how it differs from semaglutide is in tirzepatide vs semaglutide.

Frequently asked questions

Is tirzepatide FDA approved?

Yes. As of October 21, 2026, tirzepatide is FDA approved as Mounjaro (NDA 215866) and Zepbound (NDA 217806), both from Eli Lilly and Company.

What is the tirzepatide FDA approval date?

May 13, 2022, for Mounjaro. Zepbound was approved on November 8, 2023.

Are Zepbound and Mounjaro the same drug?

They contain the same active ingredient under two separate applications, with separate labels, presentations and supplement histories. Each label states its own indications.

What is human-grade tirzepatide?

"Human-grade" is not an FDA term. The only FDA-approved tirzepatide products in the United States are Mounjaro and Zepbound. Research-labelled tirzepatide is a laboratory chemical and carries no approval.

Can a pharmacy still make compounded tirzepatide?

Not under the shortage exception, which ended on February 18, 2025 (503A) and March 19, 2025 (503B). FDA's page still describes a limited policy for four or fewer prescriptions of an essentially-copy product in a calendar month.

Is tirzepatide approved in Europe?

Yes. The European Commission authorised Mounjaro on September 15, 2022.

Sources

• Drugs@FDA: NDA 215866, Mounjaro, read October 21, 2026
• Drugs@FDA: NDA 217806, Zepbound, read October 21, 2026
• FDA approval letter, Mounjaro, May 13, 2022
• FDA approval letter, Zepbound, November 8, 2023
• FDA approval letter, Mounjaro S-044, August 27, 2026
• MOUNJARO prescribing information, revised 8/2026, DailyMed
• ZEPBOUND prescribing information, revised 8/2026, DailyMed
• FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, FDA, content current April 1, 2026
• FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, FDA, April 30, 2026
• List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B, Federal Register, May 1, 2026
• FDA warning letter, Royal Peptides LLC, August 24, 2026
• Mounjaro, EPAR, European Medicines Agency