Tirzepatide Approvals Around the World: Mounjaro and Zepbound by Country

Search for “Mounjaro weight loss” and half your results will be British. Search for “Zepbound” and almost all of them will be American. That is not a coincidence or a translation error. It is the single most confusing thing about tirzepatide, and it comes down to how Eli Lilly chose to brand the same molecule in different markets.

This page maps tirzepatide’s approvals country by country, with the dates and the exact approved uses. It is a regulatory reference, not medical advice, and it says nothing about whether any of these medicines is right for anyone.

Why does tirzepatide have different brand names in different countries?

Tirzepatide is one molecule. Everywhere it is approved, it is the same once-weekly injection acting on the GIP and GLP-1 receptors, at the same six strengths.

What differs is how the regulatory paperwork was structured.

In the United States, Lilly filed the diabetes application first, which became Mounjaro under NDA 215866. When it went back for a weight indication, it filed a completely separate new drug application, NDA 217806, which the FDA classifies as a new indication submitted as a distinct application rather than consolidated into the existing one [1]. That second application became Zepbound.

In the United Kingdom and the European Union, Lilly did the opposite. It asked regulators to add the weight-management use to the existing Mounjaro authorization. There is no second brand [2][3].

Canada and Japan followed the American pattern with two brands. So when you read a British news story about “Mounjaro for weight loss,” the correct American translation is Zepbound. And when a UK pharmacy site quotes a Mounjaro price, it is not quoting the US Mounjaro price for a diabetes drug.

What is approved in the United States?

Mounjaro (NDA 215866) — approved May 13, 2022 for glycemic control in adults with type 2 diabetes, expanded December 19, 2025 to patients aged 10 and older, and expanded again on August 27, 2026 to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk [1].

Zepbound (NDA 217806) — approved November 8, 2023 for chronic weight management in adults with a BMI of 30 or greater, or 27 or greater with at least one weight-related condition, and expanded December 20, 2024 to treat moderate to severe obstructive sleep apnea in adults with obesity.

Notably absent: heart failure. Lilly withdrew its US heart failure application in May 2025 after the FDA indicated it would want a confirmatory trial, even though the SUMMIT study met both primary endpoints [16].

What is approved in the European Union?

The European Medicines Agency’s public record for Mounjaro is unusually easy to audit because the agency publishes a full log of every variation with opinion and decision dates [4][15].

• September 15, 2022 — European Commission marketing authorization for type 2 diabetes, following a CHMP positive opinion on July 21, 2022. The authorization holder is Eli Lilly Nederland B.V. [2]
• December 11, 2023 — Commission decision on variation II/0007 extending the indication to chronic weight management in adults with a BMI of 30 or greater, or 27 to under 30 with a weight-related condition. The basis was SURMOUNT-1 with five supportive SURPASS studies [4].
• April 19, 2024 — Commission decision on line extension X/0015, adding six strengths for the multi-dose pen. Europe got that presentation almost two years before the US did [4].
• February 14, 2025 — Commission decision on variation II/0027 (CHMP opinion December 12, 2024), adding the SURMOUNT-OSA results from studies I8F-MC-GPI1 and I8F-MC-GPI2 to sections 4.1, 4.8 and 5.1 of the product information [4].
• January 22, 2026 — Commission decision extending the type 2 diabetes indication to adolescents and children aged 10 and above, based on SURPASS-PEDS. The same decision date covers a variation adding SURMOUNT-5 head-to-head data against semaglutide to section 5.1 [15].
• January 29, 2026 — CHMP opinion on variation EMEA/H/C/005620/II/38. The EMA published the outcome the next day: it did not recommend a separate HFpEF indication, and instead agreed to add the SUMMIT trial information to the product information [18].
• June 25, 2026 — CHMP opinion adding the SURPASS-CVOT cardiovascular outcomes results, two months before the FDA granted a US cardiovascular indication [15].

One point deserves emphasis because it is widely misreported. The EU did not create a separate sleep apnea treatment indication. The current EU summary of product characteristics lists exactly two indications for Mounjaro, type 2 diabetes and weight management. Obstructive sleep apnoea appears only inside the weight-management wording, as one of the example comorbidities that qualifies an overweight patient, and section 4.1 then says: “For trial results with respect to obstructive sleep apnoea (OSA) and heart failure with preserved ejection fraction (HFpEF), see section 5.1” [17]. The US indication, by contrast, is a direct treatment indication for OSA.

The same is true of heart failure. In its January 2026 assessment the EMA declined to add an HFpEF indication and agreed only to put the SUMMIT trial information into the label [18]. Neither has the EU granted a standalone cardiovascular risk-reduction indication of the kind the FDA approved in August 2026; the SURPASS-CVOT data went into the product information instead.

What is approved in the United Kingdom?

The MHRA authorized tirzepatide, marketed as Mounjaro, for weight management and weight loss in adults on November 8, 2023 [3]. That happens to be the exact same calendar day the FDA approved Zepbound in the United States.

For a US reader, that single fact explains most of the cross-Atlantic confusion. British headlines about Mounjaro prescriptions, Mounjaro pharmacy supply or Mounjaro on the NHS are describing the drug Americans buy as Zepbound.

What is approved in Canada?

Canada runs the two-brand system.

• Mounjaro — Health Canada issued a Notice of Compliance on November 24, 2022 for type 2 diabetes, on a New Drug Submission classified as a new active substance [5]. The Health Canada record gives the Notice of Compliance date but not the filing date, so any specific submission date you see quoted elsewhere is unverified here.
• Zepbound KwikPen — Eli Lilly Canada announced on July 9, 2025 that Health Canada had authorized the multi-dose pen for chronic weight management in adults with obesity, or overweight with at least one weight-related condition such as high blood pressure, high cholesterol, type 2 diabetes, obstructive sleep apnea or cardiovascular disease. The approval rested on SURMOUNT-1 through SURMOUNT-4 [6].

Health Canada’s post-authorization record also shows the agency started a class-wide safety and effectiveness review of GLP-1 receptor agonists and aspiration pneumonia during general anesthesia or deep sedation in November 2024, in parallel with the FDA’s labeling work [5].

What is approved in Australia?

Australia keeps one brand, like the UK.

• December 23, 2022 — The TGA registered Mounjaro as a new chemical entity, with a decision date of December 22, for adults with insufficiently controlled type 2 diabetes, as monotherapy where metformin is unsuitable or in combination with other diabetes medicines [7].
• September 10, 2024 — Registration for chronic weight management, with a decision date of September 9, after an evaluation that began in October 2023 and ran 255 working days. The Australian weight indication wording mirrors the EU’s, naming obstructive sleep apnea among qualifying comorbidities [14].

What is approved in Japan?

Japan uses two brands but writes narrower indications than the United States.

• September 26, 2022 — Eli Lilly Japan and Mitsubishi Tanabe Pharma announced approval of Mounjaro for type 2 diabetes, describing it as the first sustained-release GIP and GLP-1 receptor agonist approved for that use in Japan. Mitsubishi Tanabe handles sales and distribution [8].
• December 27, 2024 — Japan’s Ministry of Health, Labour and Welfare approved Zepbound for “obesity disease.” The Japanese gate is considerably tighter than the US one: a patient must have high blood pressure, high cholesterol or type 2 diabetes, must not have responded adequately to diet or exercise, and must have either a BMI of at least 27 with two or more obesity-related conditions, or a BMI of at least 35. Approval rested mainly on SURMOUNT-J, a Japanese Phase 3 trial in which the 15 mg group lost 22.7 percent of body weight at week 72 compared with 1.7 percent on placebo [9].

Japanese national health insurance price listing and product release followed in March 2025.

What is approved in China and India?

China. Eli Lilly announced approval of tirzepatide for type 2 diabetes on May 21, 2024, and for long-term weight management on July 19, 2024 [10][11]. The weight approval came about four weeks after Novo Nordisk won a Chinese weight indication for semaglutide, making China one of the more directly competitive markets for the class.

India. Lilly launched Mounjaro in India on March 20, 2025 following Indian drug regulator approval, ahead of Novo Nordisk’s Wegovy launch there [12]. India follows the single-brand pattern, using Mounjaro for both diabetes and obesity.

A quick comparison table

Country or region	Diabetes brand	Weight brand	First approval	Weight indication
United States	Mounjaro	Zepbound	May 13, 2022	November 8, 2023
European Union	Mounjaro	Mounjaro	September 15, 2022	December 11, 2023
United Kingdom	Mounjaro	Mounjaro	2022	November 8, 2023
Canada	Mounjaro	Zepbound	November 24, 2022	July 9, 2025 (KwikPen)
Australia	Mounjaro	Mounjaro	December 23, 2022	September 10, 2024
Japan	Mounjaro	Zepbound	September 26, 2022	December 27, 2024
China	Mounjaro	Mounjaro	May 21, 2024	July 19, 2024
India	Mounjaro	Mounjaro	2025	March 2025 (launch)

Dates are first approval or authorization in that market for the stated use, drawn from the sources listed below. Regulatory records for some markets, particularly India, rest on company announcements and press reporting rather than a published regulator decision document.

What about buying tirzepatide from another country?

This page will not advise on personal importation, which raises both legal questions and safety questions that vary by situation.

What is worth knowing is that the counterfeit problem is real and international. The FDA says it investigates reports of suspected counterfeit GLP-1 drugs, has issued internet pharmacy warning letters over illegally marketed tirzepatide, and warns consumers about products sold under “for research purposes” labeling [13]. Counterfeit Mounjaro operations have been broken up outside the United States, including a case reported in India in April 2026 that prompted a company alert. Pens that surface in one market’s gray channels have a way of reappearing in another’s.

If cost is the driver, the questions worth asking a healthcare provider or pharmacist are about manufacturer self-pay programs, formulary alternatives and appeals, not about sourcing from abroad.

Sources

1. Mounjaro NDA approval letter — FDA
2. Mounjaro EPAR overview — European Medicines Agency
3. MHRA authorises Mounjaro (tirzepatide) for weight management and weight loss — MHRA
4. Mounjaro EPAR procedural steps after authorisation, archive — European Medicines Agency
5. Notice of Compliance information for Mounjaro — Health Canada
6. Zepbound KwikPen now approved and available in Canada — Eli Lilly Canada
7. Mounjaro Australian prescription medicine decision summary — Therapeutic Goods Administration
8. Approval of Mounjaro in Japan for type 2 diabetes — Mitsubishi Tanabe Pharma and Eli Lilly Japan
9. Zepbound approved in Japan for obesity disease — Mitsubishi Tanabe Pharma and Eli Lilly Japan
10. Eli Lilly’s diabetes drug tirzepatide gets approval in China — Reuters
11. Eli Lilly’s weight loss drug tirzepatide gets approval in China — Reuters
12. Eli Lilly launches weight-loss drug Mounjaro in India — Reuters
13. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — FDA
14. MOUNJARO registration record, chronic weight management — Therapeutic Goods Administration
15. Mounjaro EPAR procedural steps after authorisation, current — European Medicines Agency
16. Lilly Withdraws Tirzepatide Application to FDA for Heart Failure — ConscienHealth
17. Mounjaro summary of product characteristics, section 4.1 — European Medicines Agency
18. Outcome of assessment on use of Mounjaro in treatment of heart failure with preserved ejection fraction in adults with obesity, EMA/18704/2026, EMEA/H/C/005620/II/38, 30 January 2026 — European Medicines Agency