Mounjaro
Authorised
This medicine is authorised for use in the European Union
tirzepatide
MedicineHumanAuthorised
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Overview
Mounjaro is a medicine used together with diet and physical activity to treat adults, adolescents and children aged 10 years and above who have type 2 diabetes which is not satisfactorily controlled. It can be used on its own in patients who cannot take metformin (another diabetes medicine) or as an ‘add-on’ to other diabetes medicines.
Mounjaro is also used together with diet and physical activity to help adults to lose weight and keep their weight under control. It is used in adults who have obesity with a body mass index (BMI) of 30 kg/m2 or more, or who are overweight with a BMI between 27 and 30 kg/m2 and have weight-related health problems such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep). BMI is a measure of your weight in relation to your height.
Mounjaro contains the active substance tirzepatide.
Mounjaro can only be obtained with a prescription. It is given by injection using prefilled pens. It is injected once a week, under the skin of the abdomen (belly), thigh, or upper arm, and if another person gives the injection, it may also be given in the back of the shoulder.
Mounjaro should be injected on the same day each week. Patients or their carers can inject the medicine after being trained.
For more information about using Mounjaro, see the package leaflet or contact your doctor or pharmacist.
The active substance in Mounjaro, tirzepatide, acts in the same way as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). These hormones are produced in the gut and bind to specific receptors (targets) in the body, such as, among others, the pancreas and brain. This increases the amount of insulin that the pancreas releases in response to food and helps lower blood glucose levels in people with type 2 diabetes. Targeting these receptors also reduces appetite and helps people manage their weight.
Type 2 diabetes
Mounjaro was effective at controlling blood glucose in five main studies involving more than 6,000 adults with type 2 diabetes. In these studies, the main measure of effectiveness was a reduction in the proportion of haemoglobin in the blood that has glucose attached (HbA1c). This indicates how well blood glucose is controlled.
In two studies, Mounjaro lowered HbA1c by up to 2.1 and 2.6 percentage points after 40 weeks when added to lifestyle changes only or to insulin glargine with or without metformin, respectively. These results compared with no decrease or a decrease of 0.9 percentage points, respectively, in patients who received placebo (a dummy treatment).
In a third study, Mounjaro lowered HbA1c by up to 2.5 percentage points after 40 weeks when added to metformin treatment, compared with a decrease of 1.9 percentage points in patients who received semaglutide (another medicine for type 2 diabetes).
In a fourth study, Mounjaro lowered HbA1c by up to 2.4 percentage points after 52 weeks, when added to treatment with metformin with or without an SGLT2 inhibitor (a group of medicines used to control blood glucose levels), compared with a decrease of 1.3 percentage points in patients who received insulin degludec.
In a fifth study, Mounjaro lowered HbA1c by up to 2.6 percentage points after 52 weeks, when added to treatment with up to 3 oral medicines (metformin, SGLT2 inhibitors and sulphonylureas (another group of medicines used to control blood glucose levels)), compared with a decrease of 1.4 percentage points in patients who received insulin glargine.
In addition, another study involved 99 adolescents aged 10 to less than 18 years with type 2 diabetes. The study found that, after 30 weeks, Mounjaro lowered HbA1c levels by around 2 percentage points compared to 0.2 in those who received placebo.
Weight management
Mounjaro was effective at helping adults to lose weight in a study involving more than 2,500 participants who had obesity (BMI over 30 kg/m2) or who were overweight (BMI between 27 and 30 kg/m2) and had at least one weight-related health problem. In this study, people who used Mounjaro in combination with diet and physical activity for 72 weeks reduced their weight by at least 15% on average, depending on the dose they were given. This compares with 3% in people who were given a placebo. Over 85% of study participants taking Mounjaro were able to reduce their weight by at least 5%, compared with 35% of those given placebo.
For the full list of side effects and restrictions with Mounjaro, see the package leaflet.
The most common side effects with Mounjaro (which may affect more than 1 in 10 people) include low blood glucose levels (when used with sulphonylurea or insulin), nausea (feeling sick), vomiting, abdominal pain, constipation and diarrhoea.
Studies show that Mounjaro is effective in lowering blood glucose levels in adults and children aged 10 years and above with type 2 diabetes, when given alone or in combination with other diabetes medicines, without significantly increasing the patient’s risk of having low glucose levels. In adults who have obesity or are overweight with weight-related complications, treatment with Mounjaro resulted in weight loss which was mainly due to loss of fat mass. Further, Mounjaro improved other measures such as blood pressure levels and the amount of fat in the blood.
The most common side effects of Mounjaro were gut-related, generally mild or moderate in severity and occurred more often shortly after the dose was increased. Overall, side effects were considered manageable. The European Medicines Agency therefore decided that Mounjaro’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mounjaro have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Mounjaro are continuously monitored. Suspected side effects reported with Mounjaro are carefully evaluated and any necessary action taken to protect patients.
Mounjaro received a marketing authorisation valid throughout the EU on 15 September 2022.
Product information
Latest procedure affecting product information:II/0038
29/01/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Mounjaro
- Active substance
- tirzepatide
- International non-proprietary name (INN) or common name
- tirzepatide
- Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Obesity
- Overweight
- Anatomical therapeutic chemical (ATC) code
- A10BX16
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications - in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1. Weight management Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of - ≥ 30 kg/m2 (obesity) or - ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus). For trial results with respect to obstructive sleep apnoea (OSA) and heart failure with preserved ejection fraction (HFpEF), see section 5.1.
Assessment history
News on Mounjaro
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