Metformin only — Competitive Intelligence Brief

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

marketed Biguanide AMP-activated protein kinase (AMPK), mitochondrial complex I Diabetes Small molecule

Target snapshot

Metformin only (Metformin only) — Sheba Medical Center. Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK) and inhibiting mitochondrial complex I.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Metformin only TARGET	Metformin only	Sheba Medical Center	marketed	Biguanide	AMP-activated protein kinase (AMPK), mitochondrial complex I
Metformin / Pioglitazone Pill	Metformin / Pioglitazone Pill	University of Catanzaro	marketed	Antidiabetic combination (biguanide + thiazolidinedione)	AMPK activation (metformin); PPAR-γ (pioglitazone)
Linagliptin / Metformin Oral Tablet	Linagliptin / Metformin Oral Tablet	Universidad de Guanajuato	marketed	DPP-4 inhibitor / Biguanide combination	DPP-4 (dipeptidyl peptidase-4) / AMPK pathway
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+ gliclazide	metformin+ gliclazide	GlaxoSmithKline	marketed	Antidiabetic combination (biguanide + sulfonylurea)	Metformin: mitochondrial glycerophosphate dehydrogenase; Gliclazide: ATP-sensitive potassium channels on pancreatic beta cells
Glucophage tablets and Victoza	Glucophage tablets and Victoza	University Medical Centre Ljubljana	marketed	Biguanide (metformin) and GLP-1 receptor agonist (liraglutide)	AMP-activated protein kinase (metformin); GLP-1 receptor (liraglutide)
Metformin IR	Metformin IR	AstraZeneca	marketed	Biguanide	AMP-activated protein kinase (AMPK)

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