Metformin alone — Competitive Intelligence Brief

Metformin alone (Metformin alone) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Biguanide. Area: Diabetes.

phase 3 Biguanide AMP-activated protein kinase (AMPK); Complex I of the mitochondrial electron transport chain Diabetes Small molecule

Target snapshot

Metformin alone (Metformin alone) — Mount Sinai Hospital, Canada. Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK).

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Metformin alone TARGET	Metformin alone	Mount Sinai Hospital, Canada	phase 3	Biguanide	AMP-activated protein kinase (AMPK); Complex I of the mitochondrial electron transport chain
Metformin plus vildagliptin	Metformin plus vildagliptin	Sheba Medical Center	marketed	Biguanide + DPP-4 inhibitor combination	Metformin: mitochondrial glycerophosphate dehydrogenase; Vildagliptin: DPP-4 (dipeptidyl peptidase-4)
metformin+ gliclazide	metformin+ gliclazide	GlaxoSmithKline	marketed	Antidiabetic combination (biguanide + sulfonylurea)	Metformin: mitochondrial glycerophosphate dehydrogenase; Gliclazide: ATP-sensitive potassium channels on pancreatic beta cells
medical nutrition therapy + metformin	medical nutrition therapy + metformin	Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes	marketed	Combination therapy: dietary intervention + biguanide antidiabetic	AMP-activated protein kinase (AMPK) and hepatic glucose metabolism (metformin component)
Glimepiride/metformin fixed combination	Glimepiride/metformin fixed combination	Handok Inc.	marketed	Sulfonylurea/biguanide combination	ATP-sensitive potassium channel (glimepiride); mitochondrial complex I / AMPK pathway (metformin)
Metformin discontinue	Metformin discontinue	University of Texas Southwestern Medical Center	marketed	Biguanide	AMP-activated protein kinase (AMPK); hepatic glucose production
Metformin and Saxagliptin	Metformin and Saxagliptin	ikfe-CRO GmbH	marketed	Biguanide + DPP-4 inhibitor combination	Metformin: mitochondrial glycerophosphate dehydrogenase; Saxagliptin: DPP-4 (dipeptidyl peptidase-4)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Biguanide class)

1. AstraZeneca · 4 drugs in this class
2. Merck Sharp & Dohme LLC · 3 drugs in this class
3. University of Texas Southwestern Medical Center · 2 drugs in this class
4. Mount Sinai Hospital, Canada · 2 drugs in this class
5. GlaxoSmithKline · 2 drugs in this class
6. Eli Lilly and Company · 2 drugs in this class
7. University Magna Graecia · 2 drugs in this class
8. First Affiliated Hospital of Wenzhou Medical University · 1 drug in this class
9. Ente Ospedaliero Ospedali Galliera · 1 drug in this class
10. Daewoong Pharmaceutical Co. LTD. · 1 drug in this class