Zituvio FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 26, 2023.

FDA Approved: Yes (First approved October 18, 2023)
Brand name: Zituvio
Generic name: sitagliptin
Dosage form: Tablets
Company: Zydus Pharmaceuticals (USA) Inc.
Treatment for: Diabetes, Type 2

Zituvio (sitagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Type 2 diabetes is a disease that occurs when the body doesn’t make enough insulin or doesn’t use insulin well, and blood glucose levels become elevated.
• Zituvio contains the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin which works to lower blood glucose levels in type 2 diabetes by enhancing active incretin levels to increase insulin production and lower glucagon secretion from alpha cells, which in turn decreases hepatic glucose overproduction. Sitagliptin prolongs the action of the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) by inhibiting dipeptidyl peptidase-4, the enzyme responsible for the inactivation of GLP-1 and GIP.
• Sitagliptin was first approved under the brand name Januvia (sitagliptin phosphate) in 2006. Zituvio contains sitagliptin in free base form.
• Zituvio tablets are taken orally, once daily, with or without food.
• Warnings and precautions associated with Zituvio include pancreatitis, heart failure, acute renal failure, increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue, serious allergic and hypersensitivity reactions, severe and disabling arthralgia, and bullous pemphigoid.
• Common adverse reactions include upper respiratory tract infection, nasopharyngitis and headache.

Development timeline for Zituvio

Further information

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