Zituvimet FDA Approval History
Last updated by Judith Stewart, BPharm on July 24, 2024.
FDA Approved: Yes (First approved November 3, 2023)
Brand name: Zituvimet
Generic name: metformin hydrochloride and sitagliptin
Dosage form: Tablets
Company: Zydus Pharmaceuticals (USA) Inc.
Treatment for: Diabetes, Type 2
Zituvimet (metformin hydrochloride and sitagliptin) is a biguanide and dipeptidyl peptidase-4 (DPP-4) inhibitor combination 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.
- Zituvimet contains two approved drugs that are well established treatments for type 2 diabetes, both as single ingredients and in combination. Metformin hydrochloride is a biguanide that works to improve glucose tolerance in type 2 diabetes by decreasing hepatic glucose production and decreasing intestinal absorption of glucose. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by prolonging the action of the incretin hormones GLP-1 and GIP to increase insulin production in the pancreas and decrease glucose overproduction in the liver.
- The metformin and sitagliptin combination was first approved in 2007 under the brand name Janumet, which contains metformin hydrochloride and sitagliptin phosphate. The Janumet XR extended release formulation containing metformin hydrochloride extended release and sitagliptin phosphate was approved in 2012.
- Zituvimet was first approved in 2023 and contains metformin hydrochloride, and sitagliptin in free base form. The Zituvimet XR extended release formulation containing metformin hydrochloride extended release and sitagliptin free base was approved in 2024.
- Zituvimet tablets are taken orally twice daily with meals. Zituvimet XR extended release tablets are taken orally once daily with a meal.
- The Zituvimet and Zituvimet XR product labels carry a Boxed Warning for an increased risk of metformin-associated lactic acidosis. Warnings and precautions associated with Zituvimet and Zituvimet XR include pancreatitis, heart failure, acute renal failure, vitamin B12 deficiency, an increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue, hypersensitivity reactions, severe and disabling arthralgia, and bullous pemphigoid.
- Common adverse reactions include diarrhea, upper respiratory tract infection, and headache.
Development timeline for Zituvimet
Further information
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