Peptide dossier, updated Nov 1, 2026

Tirzepatide

An FDA-approved once-weekly injection that acts on two hormone receptors, GIP and GLP-1, sold by Eli Lilly as Mounjaro and Zepbound. This page is a record, not guidance on use. It covers the approvals, the label’s boxed warning, how the shortage and the compounding exemption ended, and what FDA says about compounded product.

See all 15 verified records for Tirzepatide on the Records page

In plain terms

Approved for: Type 2 diabetes (Mounjaro) and chronic weight management and obstructive sleep apnea in adults with obesity (Zepbound), per the current labels.

What it is: A lab-made molecule that copies two gut hormones, GIP and GLP-1, which raise insulin after meals, slow stomach emptying and reduce appetite. It is given as a weekly injection.

What it is said to do, and by whom:

FDA, through the labels: approved for the uses above, with a boxed warning about thyroid C-cell tumors seen in rats.
Eli Lilly and trial investigators: the SURMOUNT and SURPASS trials reported weight and blood-sugar effects; see the papers linked below.
Sellers of compounded and “research” tirzepatide: say it is equivalent to the approved drug. FDA says compounded versions are not FDA-approved and reports adverse events.

How strong the evidence is: Strong, for the approved products: large randomized trials in major journals. Not applicable to compounded or gray-market product, which FDA has not reviewed.

FDA approval

Approved

Mounjaro, May 13, 2022; Zepbound, Nov 8, 2023 (original approvals per Drugs@FDA).

Label boxed warning

Thyroid C-cell tumors

The Zepbound label’s boxed warning says tirzepatide causes dose- and duration-dependent thyroid C-cell tumors in rats, and that it is unknown whether it does in humans.

Shortage and compounding

Resolved Dec 19, 2024

FDA first declared the shortage resolved Oct 2, 2024, re-evaluated after a court remand, and issued a new decision Dec 19, 2024. Stated discretion for compounders ended Feb 18, 2025 (503A) and Mar 19, 2025 (503B).

FDA on compounded product

730+ adverse event reports

FDA says it had received more than 730 adverse event reports for compounded tirzepatide as of May 31, 2026.

HHS enforcement, Oct 30

Not covered

The draft policy’s appendix names six covered peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Tirzepatide is not one of them.

WADA prohibited list

Not named

The 2026 list we read does not name tirzepatide. We read a copy of the list, not WADA’s own file.

FDA approvals

Original approval dates are from Drugs@FDA through the openFDA API. Current uses are paraphrased from the DailyMed labels we read; the labels govern.

Brand	Application	Original approval	Current use, per the label
Mounjaro	Drugs@FDA NDA215866	May 13, 2022	Type 2 diabetes in adults and children 10 and older; reduce major cardiovascular events in adults with type 2 diabetes at high risk. DailyMed label
Zepbound	Drugs@FDA NDA217806	Nov 8, 2023	Weight reduction and maintenance in adults with obesity or overweight with a comorbidity; moderate to severe obstructive sleep apnea in adults with obesity. DailyMed label

Shortage and compounding timeline

The dates below are from FDA’s page “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize” (content current Apr 1, 2026).

Date	Event
2022	FDA says tirzepatide injection has been in shortage since 2022 due to increased demand.
Oct 2, 2024	FDA determines the shortage is resolved.
Oct 22, 2024	As part of litigation, the decision to remove tirzepatide from the shortage list is remanded to FDA for reevaluation.
Dec 19, 2024	FDA issues a new decision that the shortage is resolved. Stated discretion: 503A pharmacies until Feb 18, 2025; 503B outsourcing facilities until Mar 19, 2025.
Mar 5, 2025	The district court denies the plaintiffs’ preliminary injunction motion in Outsourcing Facilities Association v. FDA.

The page also says tirzepatide does not appear on the 503B bulks list or the drug shortage list as of its date. FDA page

FDA statements on compounded product

FDA’s page “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” (content current Oct 1, 2026).

What FDA says

As of May 31, 2026, FDA had received more than 730 reports of adverse events associated with compounded tirzepatide.
The page says FDA has warned firms selling products labeled for research or “not for human consumption.”

Read with care

FDA’s count is of reports, which do not prove the product caused the event.
We did not read FDA warning letters naming tirzepatide, so none are listed.

Sources: FDA: concerns with unapproved GLP-1 drugs

Key trial papers and records

PubMed returns 2,728 results for tirzepatide and ClinicalTrials.gov lists 309 studies as of Nov 1, 2026. The items below are examples, not a complete list.

Papers and registry records

SURPASS-2, 2021. Tirzepatide versus semaglutide once weekly in type 2 diabetes. N Engl J Med PubMed
SURMOUNT-1, 2022. Tirzepatide once weekly for the treatment of obesity. N Engl J Med PubMed
Sleep apnea, 2024. Tirzepatide for obstructive sleep apnea and obesity. N Engl J Med PubMed NCT05412004
Versus semaglutide, 2025. Tirzepatide compared with semaglutide for obesity. N Engl J Med PubMed
Cardiovascular outcomes, 2025. Tirzepatide versus dulaglutide in type 2 diabetes. N Engl J Med PubMed NCT04255433
Morbidity and mortality in obesity. Ongoing; completion listed as Oct 2027. NCT05556512

Read with care

Trial names are from paper titles or registry titles; we did not read full text.
Results describe the approved products used under medical supervision.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; tirzepatide is not one of them
The draft policy’s appendix names six peptides: BPC-157, TB-500, epitalon, Semax, KPV and MOTS-c. We read the appendix through a text extraction.
Federal Register HHS policy appendix BakerHostetler summary
Oct 1, 2026Regulatory
FDA page on unapproved GLP-1 drugs reports more than 730 adverse event reports for compounded tirzepatide
Count as of May 31, 2026.
FDA page
Mar 19, 2025Regulatory
End of stated FDA enforcement discretion for 503B outsourcing facilities compounding tirzepatide
503A discretion ended Feb 18, 2025.
FDA page
Dec 19, 2024Regulatory
FDA issues a new decision that the tirzepatide shortage is resolved
After a court remand on Oct 22, 2024. FDA’s first resolution was Oct 2, 2024.
FDA page
Nov 8, 2023Approval
FDA approves Zepbound (NDA 217806)
Original approval date per Drugs@FDA.
Drugs@FDA NDA217806
May 13, 2022Approval
FDA approves Mounjaro (NDA 215866)
Original approval date per Drugs@FDA.
Drugs@FDA NDA215866

Still not covered

Left off rather than guessed:

Sleep apnea approval date: Zepbound’s sleep apnea use appears in the current label; we did not confirm the date it was added.
Counterfeit and warning letters: we did not open FDA warning letters or counterfeit alerts naming tirzepatide.
Safety beyond the boxed warning: this dossier does not summarize adverse reactions. See the labels.
HHS policy: we read the draft policy appendix through a text extraction, not the original PDF layout. It names six covered peptides and not this drug.
Patents, SEC filings and sponsor results releases: not researched for this dossier, except where cited.
Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
Unread items: full text of every paper; EU and other non-US regulators; WADA’s own file for the 2026 list; FDA warning letters other than those listed.