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Mounjaro
Published
Product name
Mounjaro
Active ingredient
Tirzepatide
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Mounjaro (tirzepatide) was approved for the following therapeutic use:
Type 2 Diabetes Mellitus:
Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is not tolerated or contraindicated.
- in addition to other medicinal products for the treatment of type 2 diabetes.
How this medicine works
Tirzepatide is a long-acting dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It is a 39-amino acid peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs half-life. Both receptors are present on the pancreatic α and β endocrine cells, brain, heart, vasculature, immune cells (leukocytes), gut and kidney. GIP receptors are also present on adipocytes.
Tirzepatide is selective to human GIP and GLP-1 receptors. Tirzepatide has high affinity to both the GIP and GLP-1 receptors. The activity of tirzepatide on the GIP receptor is similar to native GIP hormone. The activity of tirzepatide on the GLP-1 receptor is lower compared to native GLP 1 hormone. Tirzepatide is a biased agonist at the GLP-1 receptor with preferential signaling towards the activation of adenylyl cyclase as opposed to the recruitment of β-arrestin.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Mounjaro was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- MOUNJARO tirzepatide 5 mg/0.5 mL solution for injection pre-filled pen (379330)
- MOUNJARO tirzepatide 7.5 mg/0.5 mL solution for injection pre-filled pen (379331)
- MOUNJARO tirzepatide 12.5 mg/0.5 mL solution for injection pre-filled pen (379332)
- MOUNJARO tirzepatide 10 mg/0.5 mL solution for injection pre-filled pen (379333)
- MOUNJARO tirzepatide 15 mg/0.5 mL solution for injection pre-filled pen (379334)
- MOUNJARO tirzepatide 2.5 mg/0.5 mL solution for injection pre-filled pen (382625)