Molecule
Saxagliptin is a dipeptidyl peptidase 4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, among other approved uses. MedsAcross supplies Saxagliptin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Saxagliptin 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. Limitations of use: Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Source: US FDA prescribing information
Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production. In patients with type 2 diabetes mellitus, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved. Saxagliptin is a competitive DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus.
Source: US FDA prescribing information
Recommended dosage is 2.5 mg or 5 mg orally once daily taken regardless of meals. Patients with an eGFR <45 mL/min/1.73 m 2 (moderate or severe renal impairment, or end-stage renal disease): Recommended dosage is 2.5 mg once daily regardless of meals. Assess renal function before starting saxagliptin tablets and periodically thereafter. Limit the dosage of saxagliptin tablets to 2.5 mg daily for patients also taking strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole).
Source: US FDA prescribing information
Saxagliptin tablets are contraindicated in patients with a history of a serious hypersensitivity reaction to saxagliptin or any of the ingredients in saxagliptin tablets. Reactions such as anaphylaxis, angioedema, or exfoliative skin conditions have been reported with saxagliptin tablets. History of a serious hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to saxagliptin or any of the ingredients in saxagliptin tablets.
Source: US FDA prescribing information
Pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue saxagliptin. Heart Failure: Consider the risks and benefits of saxagliptin in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues: Consider a lower dosage of insulin or insulin secretagogue when used in combination with saxagliptin. Hypersensitivity-Related Events: There have been postmarketing reports of serious hypersensitivity reactions such as anaphylaxis, angioedema, and exfoliative skin conditions. If hypersensitivity reactions occur, discontinue saxagliptin, treat promptly, and monitor until signs and symptoms resolve. Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors.
Source: US FDA prescribing information
The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis Heart Failure Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues Hypersensitivity Reactions Severe and disabling arthralgia Bullous pemphigoid Most common adverse reactions (incidence ≥5% and more often than placebo) are upper respiratory tract infection, urinary tract infection, and headache. Peripheral edema was reported more commonly in patients treated with the combination of saxagliptin and a thiazolidinedione (TZD) than in patients treated with the combination of placebo and TZD.
Source: US FDA prescribing information
Strong CYP3A4/5 inhibitors (e.g., ketoconazole): Coadministration with saxagliptin significantly increases saxagliptin concentrations. Limit saxagliptin dosage to 2.5 mg once daily when coadministered with a strong CYP3A4/5 inhibitor.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Saxagliptin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Saxagliptin 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Saxagliptin 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Saxagliptin and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Saxagliptin on 31 July 2009, according to Drugs@FDA.
Yes. Saxagliptin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Saxagliptin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Saxagliptin is classified under ATC code A10BH03 (Saxagliptin).
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