Mounjaro Approved in Brazil: What It Means

When regulatory agencies give the green light to new meds, it’s a big deal, especially if these meds could help a lot of people. In Brazil, Anvisa (the health regulation agency) calls the shots, checking if new products are safe, work well, and are up to snuff before they hit the market(ANVISA, 2025). They recently approved Mounjaro (active ingredient: tirzepatide) for obesity and overweight people with other health issues. Before it was just for type 2 diabetes.

Mounjaro was already being sold in Brazil for blood sugar control in type 2 diabetics since 2023. Tirzepatide helps cut blood sugar and with losing weight, shown in studies before it was first approved (ANVISA, 2025). Doctors were prescribing it off-label for weight loss, but in June 2025, Anvisa made it official. Now, adults with a BMI of 30 or higher (that’s obese) or a BMI of 27 or higher with related health problems like high blood pressure can use it (AGÊNCIA BRASIL, 2025; ANVISA, 2025).

This decision was based on solid proof that it works and is safe, from clinical trials that showed peeps lost body mass when they used tirzepatide and also ate healthier and exercised (ANVISA, 2025). Studies show many agonists may help a lot with body mass and other health numbers. (ANVISA, 2025, p. 2).

This approval has a bunch of effects here. Medically, it’s good news because being able to use Mounjaro is a step forward in fighting obesity, which is a widespread disease that causes several long-term conditions that can cause death(ANVISA, 2025). It and its side effects are a big health problem in Brazil. Having access to a medicine that is helpful could reduce the bad outcomes.

But, even if it is helpful, getting Mounjaro might be tricky in Brazil. Market research says it can cost between R$ 1,400 and R$ 2,300 monthly, depending. So most folks can’t buy it(AGÊNCIA BRASIL, 2025). This brings up questions about equal access to healthcare and whether the government should help cover expensive drugs like this.

It’s also tricky to keep the use of Mounjaro in check as demand goes up. Anvisa put limits on making similar versions, including tirzepatide, due to safety worries (UOL Notícias, 2025). It shows peeps are trying to keep things safe and protecting patients from dodgy treatments.

Another thing is that people are getting it from other countries, like Paraguay. (PharmaBR.News, 2025). This shows how complex global health controls can go.

Doctors also need to give folks correct advice on how to use Mounjaro, what might happen, and to have them visit multidisciplinary visits. While it can be effective, folks could still face some challenges and it is good to have monitoring.

To sum up, Anvisa approving Mounjaro is a step forward in Brazil for tackling obesity, giving doctors and patients another tool (ANVISA, 2025). All the results show the need for policies that provide fair access, safe use, and good medical care. The rules of this market that evidence all the health practices are also complex when it comes to inovative drugs.

REFERENCES

AGÊNCIA BRASIL. Anvisa approves the use of the drug Mounjaro for weight loss. Agência Brasil, June 9, 2025. Available at: https://agenciabrasil.ebc.com.br/saude/noticia/2025-06/anvisa-aprova-uso-do-medicamento-mounjaro-para-perda-de-peso. Accessed on: Jan. 25, 2026.

ANVISA. Mounjaro® (tirzepatide): new indication — Brazilian Health Regulatory Agency. Brazil: Anvisa, June 9, 2025. Available at: https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/mounjaro-r-tirzepatida-nova-indicacao. Accessed on: Jan. 25, 2026.

PHARMABR.NEWS. Brazilians turn to Paraguayan-sourced Mounjaro pens amid access gaps in Brazil. PharmaBR.News, Oct. 25, 2025. Available at: https://pharmabr.news/2025/10/25/brazilians-turn-to-paraguayan-sourced-mounjaro-pens-amid-access-gaps-in-brazil/. Accessed on: Jan. 25, 2026.

UOL NOTÍCIAS. Anvisa bans compounded versions of Ozempic, Mounjaro, and Wegovy in Brazil. UOL Notícias, Aug. 25, 2025. Available at: https://noticias.uol.com.br/saude/ultimas-noticias/redacao/2025/08/25/anvisa-proibe-versoes-manipuladas-de-ozempic-mounjaro-e-wegovy-no-brasil.htm. Accessed on: Jan. 25, 2026.