XIGDUO XR

Peak

dapagliflozin and metformin hydrochloride

NDAORALTABLET, EXTENDED RELEASE
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
179

Mechanism of Action

Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose, and…

Clinical Trials (5)

NCT07450820N/ARecruiting

OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD

Started Feb 2026
14,308 enrolled
Chronic Kidney Disease
NCT07404137Phase 1Recruiting

A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food

Started Feb 2026
26 enrolled
Healthy Participants
NCT07222917Phase 2Recruiting

A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

Started Dec 2025
218 enrolled
Chronic Kidney Disease and Hypertension
NCT06979388Phase 1Completed

A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.

Started May 2025
14 enrolled
Healthy Participants
NCT06942910Phase 2Recruiting

A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria

Started May 2025
224 enrolled
Chronic Kidney Disease With High Proteinuria

Loss of Exclusivity

LOE Date
May 12, 2031
63 months away
Patent Expiry
May 12, 2031
Exclusivity Expiry
Dec 12, 2027

Patent Records (5)

Patent #ExpiryTypeUse Code
6515117
Oct 4, 2025Expired
SubstanceProduct
U-493
6515117*PED
Apr 4, 2026
8501698
Jun 20, 2027
Product
U-493
8501698*PED
Dec 20, 2027
7919598
Dec 16, 2029
Substance