EU regulators decline heart failure indication for Mounjaro but add trial data to label

European regulators have declined to add a heart failure indication to Mounjaro, but agreed to place results from a 731-patient trial in the medicine's European product information ^[1].

The European Medicines Agency assessed an application to extend use of Mounjaro, whose active substance is tirzepatide, to treat symptomatic long-term heart failure with preserved ejection fraction (HFpEF) in adults with obesity ^[1]. HFpEF is a condition in which the heart becomes too stiff to relax and fill properly between beats, so it pumps out less blood than the body needs. Symptoms include difficulty breathing, tiredness and swelling, usually of the ankles and feet ^[1].

The application was supported mainly by one study of 731 adults with obesity and chronic HFpEF. Participants received either Mounjaro or a placebo ^[1]. The main measures of effectiveness were changes in the severity of heart failure symptoms and their impact on everyday life, scored with a questionnaire called KCCQ-CSS after 52 weeks of treatment, and the number of cardiovascular deaths or episodes of worsening heart failure. The worsening events included hospital stays for heart failure, urgent visits for heart failure and intensification of diuretic treatment, a medicine that increases urine production to reduce fluid buildup ^[1].

In its conclusions, the agency said Mounjaro did not reduce deaths due to heart and circulation problems in adults with obesity and HFpEF, but that it significantly reduced the number of hospitalizations for heart failure and improved patients' quality of life ^[1]. The agency also said uncertainty remains about whether those results are independent of weight loss, and that use of Mounjaro in this group of people is already covered by the approved weight-management indication. It concluded that a separate HFpEF indication is not needed ^[1].

The prescribing information will be updated so that health professionals have current data on the effects of Mounjaro in adults with obesity and chronic HFpEF ^[1]. The EU product information already directs readers to heart failure trial results in section 5.1 in connection with the weight-management indication ^[2].

Mounjaro has been authorized in the European Union since September 2022 and is given as an injection ^[1]. The company told the agency that there are no consequences for patients in clinical trials using Mounjaro ^[1].

Why it matters for patients

HFpEF will not appear as an approved use on the EU label for Mounjaro. The trial results will appear in the product information instead, so clinicians treating adults who have both obesity and HFpEF can see them ^[1].

Prescribing in Europe remains governed by the existing indications. For weight management, Mounjaro is approved for adults with a BMI of 30 kg/m² or more, or a BMI of 27 to under 30 kg/m² with at least one weight-related condition such as high blood pressure, abnormal blood fats, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes ^[2]. The agency's reasoning states that this indication already covers adults with obesity and HFpEF ^[1].

The label's safety information is unchanged by this decision. It lists warnings about acute pancreatitis, gastrointestinal side effects such as nausea, vomiting and diarrhea, low blood sugar when the drug is used with insulin or a sulfonylurea, and the risk of aspiration during general anesthesia or deep sedation ^[2].

Whether a similar label change is planned or has been made in the United States has not been reported.

What happens next

The agency published the outcome of its assessment on 30 January 2026 ^[1]. It said the prescribing information will be updated, but a date for the revised text has not been disclosed ^[1]. The company also reported no consequences for participants in clinical trials using Mounjaro ^[1].