MOUNJARO Eli Lilly Australia Pty Ltd
Product name
MOUNJARO
Sponsor
Accepted date
Dec-2025
Active ingredients
tirzepatide
Proposed indication
MOUNJARO (tirzepatide) is proposed as a treatment to lower the risk of cardiovascular problems, such as heart attack, stroke, or death from heart disease - in adults who have type 2 diabetes and already have cardiovascular disease. The proposed indication is not limited to patients with T2DM and pre-existing heart disease - 19.2% in the main SURPASS-CVOT study had had a previous stroke
Application type
C (new indication)
Publication date
Dec-2025