ONGLYZA
LOE ApproachingNDAORALTABLET
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
5
Data completeness
5/8 — Partial
ONGLYZA by AstraZeneca is 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. First approved in 2009.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONGLYZA (saxagliptin) is an oral small-molecule DPP4 inhibitor approved in 2009 for type 2 diabetes mellitus. It works by slowing the inactivation of incretin hormones (GLP-1 and GIP), thereby increasing their concentrations and reducing fasting and postprandial glucose in a glucose-dependent manner. The drug is administered as an oral tablet and represents a glucose-dependent approach to insulin secretion.
$0.058BPart D
LOE Approaching2.4 years to LOEProduct is 2.5 years from loss of exclusivity with modest Medicare claims (~64K), signaling a contracting portfolio position requiring efficiency-focused manufacturing and operational excellence.
Mechanism of Action
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 DPP4…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Korean Post-marketing Surveillance for Onglyza®
Started Mar 2012
3,433 enrolled
Diabetes Mellitus, Type 2
BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Started Mar 2011
0Type 2 Diabetes
Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use
Started Oct 2010
542 enrolled
Type 2 Diabetes Mellitus
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Started Feb 2010
24 enrolled
Type 2 Diabetes Mellitus
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
Started Nov 2009
30 enrolled
Diabetes Mellitus
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.