Tirzepatide Approvals by Country: Mounjaro and Zepbound Worldwide

Tirzepatide is approved for type 2 diabetes in the United States, the European Union, the United Kingdom, Canada, Australia, Japan, China and India, and for weight management in those markets as well. The brand name on the box depends on where you live and what it is prescribed for. In the US, tirzepatide for diabetes is sold as Mounjaro and tirzepatide for weight loss is sold as Zepbound ^[10]. In the UK, Europe, Australia and India, the same molecule carries the Mounjaro name for both uses ^[12][7][14]. Japan and Canada follow the US pattern: Mounjaro for diabetes, Zepbound for weight ^[9][5][6].

The split traces back to how each regulator handled the weight-loss approval. The US FDA approved Mounjaro for type 2 diabetes on May 13, 2022 ^[8], and when the weight-loss approval came in late 2023, it arrived under a second brand name, Zepbound, which reached the US market in December 2023 ^[10][9]. Other regulators extended the existing Mounjaro authorization to cover weight management instead, so no second name was needed there.

Is Mounjaro the same drug as Zepbound?

Yes. Tirzepatide is the active ingredient in both products ^[10]. In Japan, where both brands are sold, the companies state that Mounjaro for diabetes contains the same compound as Zepbound, with the same six dose strengths from 2.5 mg to 15 mg ^[9]. The difference is the brand name and the approved use, not the medicine itself.

What is tirzepatide approved for in the United States?

The FDA approved Mounjaro under NDA 215866, an application dated September 14, 2021, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes ^[1]. Eli Lilly launched it in the US on June 7, 2022 ^[8]. At approval, the FDA deferred a required pediatric study in ages 10 to 17 as a postmarketing requirement ^[1].

The weight-loss approval followed in late 2023 under the Zepbound name, and tirzepatide has been on the US market for obesity since December 2023 ^[10][9].

One US application did not make it. Lilly withdrew its FDA application for a heart failure indication, specifically heart failure with preserved ejection fraction (HFpEF), announced in a May 1, 2025 investor briefing. Chief Scientific Officer Dan Skovronsky said the FDA wanted an additional confirmatory trial despite positive SUMMIT phase 3 data, and that regulatory reviews were continuing in other countries ^[16].

When was Mounjaro approved in Europe?

The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on July 21, 2022, and the European Commission issued the marketing authorization on September 15, 2022, to holder Eli Lilly Nederland B.V. of Utrecht, under product number EMEA/H/C/005620 ^[2].

Weight management came later through a variation (II/0007): CHMP opinion on November 9, 2023 and Commission decision on December 11, 2023, based on the pivotal SURMOUNT-1 study plus the five supportive SURPASS diabetes studies ^[4]. A separate extension (X/0015) added six multidose KwikPen strengths, with an opinion on February 22, 2024 and a decision on April 19, 2024 ^[4]. A further variation (II/0027) added results from two obstructive sleep apnea studies to the product information, with an opinion on December 12, 2024 and a decision on February 14, 2025 ^[4].

More recently, the EU extended the diabetes indication to adolescents and children aged 10 and above, with an opinion on December 11, 2025 and a decision on January 22, 2026. On the same decision date, results from SURMOUNT-5, a 72-week trial in 751 adults comparing tirzepatide with semaglutide, were added to section 5.1 of the label ^[15]. A CHMP opinion on June 25, 2026 added the SURPASS-CVOT cardiovascular trial results to sections 4.1, 4.4, 4.8 and 5.1 ^[15].

What does the EU label actually list as approved uses?

The summary of product characteristics lists two indications: type 2 diabetes in adults, adolescents and children aged 10 and above, and weight management in adults with a BMI of 30 or more, or 27 to under 30 with at least one weight-related comorbidity ^[17].

Obstructive sleep apnea appears in section 4.1 only as an example comorbidity within the weight-management indication, and the label points readers to section 5.1 for trial results on OSA and HFpEF rather than listing either as a standalone indication ^[17].

On heart failure, the EMA finalized an assessment on January 30, 2026 (EMA/18704/2026) and did not recommend a separate HFpEF indication, while agreeing to add the SUMMIT data to the product information ^[18]. The EMA’s reasoning: SUMMIT, involving 731 adults, reduced heart failure hospitalizations and improved quality of life but not cardiovascular deaths; it remained uncertain whether the effect was independent of weight loss; and the population was already covered by the weight-management indication ^[18].

Is Mounjaro approved for weight loss in the UK?

Yes. The MHRA authorized a new weight-loss and weight-management indication for Mounjaro on November 8, 2023, via the national application route, for adults aged 18 and over. The medicine was already used for type 2 diabetes in the UK at that point ^[3]. Eligibility covers adults with a BMI of 30 or more, or a BMI of 27 to 30 with weight-related problems such as prediabetes, high blood pressure, high cholesterol or heart problems ^[3].

The MHRA drew on advice from the independent Commission on Human Medicines and on two trials, SURMOUNT-1 and SURMOUNT-2 ^[3]. In SURMOUNT-1, 2,539 adults were treated over 72 weeks; the average percentage change in weight was -16.0% on the 5 mg dose, -21.4% on 10 mg and -22.5% on 15 mg, versus -2.4% on placebo ^[3]. The indication was granted to Eli Lilly Nederland B.V., and the pens come in six strengths from 2.5 mg to 15 mg ^[3].

Why does the UK call the weight-loss drug Mounjaro instead of Zepbound?

Because the MHRA extended the existing Mounjaro authorization rather than registering a second brand. Reuters notes that Mounjaro is sold in the UK and Europe under the same brand name for both diabetes and weight loss, while it is sold as Zepbound for obesity in the US ^[12]. UK Mounjaro prescribed for weight loss corresponds to what American patients know as Zepbound ^[12].

Is tirzepatide approved in Canada?

Yes, under both names. Health Canada issued a Notice of Compliance for Mounjaro on November 24, 2022, to Eli Lilly Canada, as a New Drug Submission with New Active Substance status, in six strengths from 2.5 mg to 15 mg per 0.5 mL ^[5].

Zepbound KwikPen was authorized by Health Canada on May 13, 2025, for chronic weight management in adults with a BMI of 30 or more, or 27 to under 30 with at least one weight-related condition such as hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea or cardiovascular disease. Lilly announced its availability in Canada on July 9, 2025 ^[6]. The authorization was based on SURMOUNT-1 through SURMOUNT-4; Lilly’s press release reports that in SURMOUNT-1, people treated with the 15 mg dose lost an average of 21.8 kg (48 lb) at 72 weeks, compared with 3.2 kg on placebo ^[6].

Is tirzepatide approved in Australia?

Yes, under the Mounjaro name for both uses. The TGA approved Mounjaro as a new chemical entity for type 2 diabetes on December 22, 2022, registered on December 23, 2022, sponsored by Eli Lilly Australia ^[7]. The chronic weight management extension was decided on September 9, 2024 and registered on September 10, 2024, after an evaluation that commenced on October 3, 2023 and took 255 working days ^[14]. The Australian weight indication covers adults with a BMI of 30 or more, or 27 to under 30 with at least one comorbidity such as hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, prediabetes or type 2 diabetes ^[14].

Is Mounjaro approved in Japan?

Yes, for diabetes, with Zepbound approved separately for weight. Japan’s Ministry of Health, Labour and Welfare approved Mounjaro on September 26, 2022 for type 2 diabetes, as a single-use autoinjector (ATEOS) in six strengths, distributed and sold by Mitsubishi Tanabe Pharma; the approval rested on SURPASS J-mono, SURPASS J-combo, SURPASS-1 and SURPASS-5 ^[8]. Mounjaro launched in Japan in April 2023 ^[9].

Zepbound was approved on December 27, 2024 for “obesity disease” ^[9]. Japan’s eligibility gate is narrower than in most countries: patients must have hypertension, dyslipidemia or type 2 diabetes, respond inadequately to diet or exercise therapy, and meet either a BMI of 27 or more with at least two obesity-related health conditions, or a BMI of 35 or more ^[9]. The approval was based on SURMOUNT-J, in which the mean percent change in body weight at week 72 was -17.8% in the 10 mg group and -22.7% in the 15 mg group, versus -1.7% on placebo. Japan defines obesity as a BMI of 25 or more ^[9].

What about China and India?

China’s regulator approved tirzepatide for type 2 diabetes, announced by Lilly on May 21, 2024 ^[10], and for weight loss, announced through a Lilly social media post on July 19, 2024 ^[11]. For context, Novo Nordisk’s Ozempic was approved in China in 2021 and Wegovy in June 2024 ^[10][11].

Lilly launched Mounjaro in India on March 20, 2025 after approval by the Indian regulator, ahead of Novo Nordisk, whose Wegovy is approved in India but without a confirmed launch date ^[12]. Indian prices are 4,375 rupees ($50.67) for a 5 mg vial and 3,500 rupees ($40.54) for a 2.5 mg vial, which works out to roughly $200 a month for a patient taking the 5 mg weekly dose ^[12]. The same report lists US figures for comparison: Mounjaro at a list price of $1,086.37 per monthly fill, and Zepbound vials at about $499 for a month’s supply paid in cash ^[12]. Lilly says pricing across countries cannot be compared, given significant variation in healthcare systems, economies and reimbursement policies ^[12].

Tirzepatide approvals by country at a glance

Country	Diabetes brand	Diabetes approval	Weight brand	Weight approval
United States	Mounjaro	May 13, 2022 [8]	Zepbound	Late 2023 [10]
European Union	Mounjaro	September 15, 2022 [2]	Mounjaro	December 11, 2023 [4]
United Kingdom	Mounjaro	In use for diabetes before the weight approval [3]	Mounjaro	November 8, 2023 [3]
Canada	Mounjaro	November 24, 2022 [5]	Zepbound	May 13, 2025 [6]
Australia	Mounjaro	December 23, 2022 [7]	Mounjaro	September 10, 2024 [14]
Japan	Mounjaro	September 26, 2022 [8]	Zepbound	December 27, 2024 [9]
China	Tirzepatide	Announced May 21, 2024 [10]	Tirzepatide	Announced July 19, 2024 [11]
India	Mounjaro	Launched March 20, 2025 [12]	Mounjaro	Launched March 20, 2025 [12]

What about buying tirzepatide from another country or online?

The FDA has issued internet pharmacy warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide. Such products may be counterfeit and could contain the wrong ingredients, or too little, too much or no active ingredient at all ^[13]. The agency has also warned companies selling tirzepatide falsely labeled “for research purposes” or “not for human consumption” while selling directly to consumers with dosing instructions ^[13].

Fraudulent compounded tirzepatide has carried labels naming compounding pharmacies that do not exist, or licensed pharmacies that did not make the products ^[13]. As of May 31, 2026, the FDA had received more than 730 adverse event reports associated with compounded tirzepatide, and it maintains import alert 66-80 on GLP-1 active pharmaceutical ingredients with potential quality concerns ^[13]. The FDA’s guidance for patients is to obtain a prescription from a doctor, fill it at a state-licensed pharmacy, and use the agency’s BeSafeRx resources when buying medicines online ^[13].

Sources

1. US Food and Drug Administration. Mounjaro (tirzepatide) injection. NDA approval letter.
2. European Medicines Agency. Mounjaro: European public assessment report (EPAR).
3. UK Government. MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss.
4. European Medicines Agency. Mounjaro, INN-tirzepatide: procedural steps taken and scientific information after authorisation.
5. Health Canada. Notice of Compliance Information: Mounjaro. November 24, 2022.
6. Eli Lilly Canada. Zepbound KwikPen (tirzepatide injection), the first and only dual receptor agonist for the treatment of obesity, now approved and available in Canada. July 9, 2025.
7. Therapeutic Goods Administration. Mounjaro: Australian product information. December 22, 2022.
8. Eli Lilly Japan and Mitsubishi Tanabe Pharma Corporation. Approval of Mounjaro, the world’s first sustained release GIP/GLP-1 receptor agonist for the treatment of type 2 diabetes in Japan. September 26, 2022.
9. Eli Lilly Japan and Mitsubishi Tanabe Pharma Corporation. Zepbound, a long-acting GIP/GLP-1 receptor agonist, approved for the chronic disease of obesity disease with multiple factors. December 27, 2024.
10. Reuters. Eli Lilly’s diabetes drug tirzepatide gets approval in China. May 21, 2024.
11. Reuters. Eli Lilly’s weight loss drug tirzepatide gets approval in China. July 19, 2024.
12. Reuters. Eli Lilly launches weight-loss drug Mounjaro in India, beats Novo Nordisk to major market. March 20, 2025.
13. US Food and Drug Administration. FDA’s concerns with unapproved GLP-1 drugs used for weight loss.
14. Therapeutic Goods Administration. Mounjaro (Eli Lilly Australia Pty Ltd): prescription medicine registration. September 10, 2024.
15. European Medicines Agency. Mounjaro, INN-tirzepatide: procedural steps taken and scientific information after the authorisation.
16. ConscienHealth. Lilly withdraws tirzepatide application to FDA for heart failure. May 3, 2025.
17. European Medicines Agency. Mounjaro, INN-tirzepatide: EPAR product information.
18. European Medicines Agency. Outcome of assessment on use of Mounjaro in treatment of heart failure with preserved ejection fraction in adults with obesity. January 30, 2026.