Mounjaro FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 9, 2022.
FDA Approved: Yes (First approved May 13, 2022)
Brand name: Mounjaro
Generic name: tirzepatide
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Diabetes, Type 2
Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- Mounjaro works by activating the body's receptors for GIP and GLP-1, which are natural incretin hormones.
- Mounjaro is administered via subcutaneous injection once weekly.
- Warnings and precautions associated with Mounjaro include pancreatitis; hypoglycemia with concomitant use of insulin secretagogues or insulin; hypersensitivity reactions; acute kidney injury; severe gastrointestinal disease; diabetic retinopathy complications in patients with a history of diabetic retinopathy; and acute gallbladder disease.
- Common adverse reactions include nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Development timeline for Mounjaro
Further information
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