As of September 2026, tirzepatide is an approved medicine in the US and the EU. The FDA approved it for type 2 diabetes, weight management and obstructive sleep apnea. Most of the main trials ran one to three years. A vial sold as tirzepatide outside a pharmacy was not in those trials, and looking at it will not tell you what it holds.
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What is tirzepatide?
Tirzepatide is a lab-made peptide that mimics two gut hormones at once, GIP and GLP-1. Eli Lilly developed it. The FDA first approved it in 2022 as Mounjaro for type 2 diabetes, and the EMA authorised Mounjaro in the same year.
Does tirzepatide work?
For type 2 diabetes, weight management and obstructive sleep apnea, the FDA reviewed the trials and approved it. The record counts 8 completed randomized trials and lists three study rows, so the number shows as 8+ until every trial is listed.
What we found. 8+ completed randomized trials counted on the record. 3 study rows listed below, and two of them stand for whole programs of trials.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| SURMOUNT-1 trial of tirzepatide in obesity | People | Published. A main approval trial | Mean weight loss of 16.0 to 22.5% in adults with obesity or overweight, measured against placebo |
| SURPASS trial program (several trials) | People | Published. The basis for the diabetes approval | A larger drop in HbA1c, a blood sugar measure, than the comparison treatments in type 2 diabetes |
| Zepbound sleep apnea approval trials | People | Published. The basis for the 2025 sleep apnea approval | A lower apnea-hypopnea index, a sleep apnea measure, in adults with obesity and moderate-to-severe obstructive sleep apnea |
Is tirzepatide safe?
The record names nausea, other stomach and gut side effects, gallbladder problems and rare pancreatitis. Most of the main trials ran one to three years. Heart-outcome and cancer-risk data beyond five years are still maturing. Past that point, nobody knows yet. These lines describe Mounjaro and Zepbound. A vial that carries the name tirzepatide and no brand is a separate question, two sections down.
Is tirzepatide legal?
- United States
- Approved by the FDA as Mounjaro (2022) for type 2 diabetes and as Zepbound (2023) for weight management. In 2025 the FDA also approved Zepbound for moderate-to-severe obstructive sleep apnea.
- European Union
- Approved by the EMA as Mounjaro in 2022.
- Sport
- Monitored by WADA. It is not on the Prohibited List, so it is not banned. WADA's 2026 Monitoring Program lists markers of semaglutide and tirzepatide, in and out of competition, which means WADA watches how they are used.
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as tirzepatide?
The trials above tested the maker's own products, sold as Mounjaro and Zepbound. This record holds no sign that tirzepatide is sold outside pharmacies. If a vial came to you some other way, none of those trials tested it, and the checklist lists what to ask the seller.
What don't we know?
- What happens to heart outcomes after more than five years. Those data are still maturing.
- Whether cancer risk changes over the long term. Those data are still maturing too.
- What the trials would show past three years. Most of the main ones ran one to three.
- What is in any vial that did not come from a pharmacy.
The other side
Mounjaro and Zepbound come with a prescription and a doctor's care, and large randomized trials stand behind the approvals. The open questions on this page are about time: what the data show after the trial years end.
What would change this record?
- Long-term studies of heart and safety outcomes, run after approval, once they are finished and published.
Change log
- Sport status corrected from "Not named" to "Monitored". WADA's 2026 Monitoring Program lists markers of semaglutide and tirzepatide.
- Record checked. No change logged yet.
Three questions to ask next
- What does 'research use only' actually mean?
- How can you tell if a peptide vendor is legitimate?
- How do you read a certificate of analysis?
Ask better questions.
More questions about tirzepatide
Is Mounjaro the same as tirzepatide?
- Mounjaro is one of two brand names for tirzepatide. The other is Zepbound.
Is Zepbound the same as Mounjaro?
- Both are brand names for tirzepatide. The FDA approved Mounjaro in 2022 for type 2 diabetes. It approved Zepbound in 2023 for weight management and in 2025 for moderate-to-severe obstructive sleep apnea.
What is tirzepatide approved for?
- In the US: type 2 diabetes, weight management and moderate-to-severe obstructive sleep apnea. The EMA authorised Mounjaro in 2022, and the record's EU line names no use.
Is tirzepatide safe over many years?
- Nobody knows yet. The record says heart-outcome and cancer-risk data beyond five years are still maturing. Most of the main trials ran one to three years.
Is tirzepatide banned in sport?
- No. It is not on WADA's Prohibited List. WADA's 2026 Monitoring Program lists markers of semaglutide and tirzepatide, so WADA watches how they are used. If you compete, check the current List.
Record checked on . Each source shows the date it was checked.
In the same group
- AOD-9604Grade B2 completed randomized trials
- CagrilintideGrade B3 completed randomized trials
- Dulaglutide (Trulicity)Grade A9+ completed randomized trials
- Exenatide (Byetta, Bydureon)Grade A8+ completed randomized trials
- Liraglutide (Victoza, Saxenda)Grade A6+ completed randomized trials
- MOTS-cGrade D0 completed randomized trials