Metformin up-titration — Competitive Intelligence Brief

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

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

Target snapshot

Metformin up-titration (Metformin up-titration) — Research Clinical Centre of the Russian Railways, JSC. 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 up-titration TARGET	Metformin up-titration	Research Clinical Centre of the Russian Railways, JSC	marketed	Biguanide	AMP-activated protein kinase (AMPK), mitochondrial respiratory chain complex I
Placebo plus metformin	Placebo plus metformin	University Magna Graecia	marketed	Biguanide	AMP-activated protein kinase (AMPK), mitochondrial glycerophosphate dehydrogenase
CSII followed by MET	CSII followed by MET	Sun Yat-sen University	marketed	Insulin + Biguanide combination regimen	Insulin receptor (insulin); AMP-activated protein kinase pathway (metformin)
SGLT2i+Metformin+Linagliptin	SGLT2i+Metformin+Linagliptin	Huazhong University of Science and Technology	marketed	Combination antidiabetic agent (SGLT2 inhibitor + biguanide + DPP-4 inhibitor)	SGLT2 transporter, mitochondrial complex I (metformin), dipeptidyl peptidase-4
GLIMEPIRIDE + METFORMIN	GLIMEPIRIDE + METFORMIN	Sanofi	marketed	Sulfonylurea + biguanide combination	ATP-sensitive potassium channel (Kir6.2/SUR1); mitochondrial respiratory chain complex I
or Metformin HCl alone	or Metformin HCl alone	Bristol-Myers Squibb	marketed	Biguanide	AMP-activated protein kinase (AMPK); mitochondrial glycerophosphate dehydrogenase
Metformin + Clomiphene	Metformin + Clomiphene	University of Auckland, New Zealand	marketed	Combination therapy: biguanide + selective estrogen receptor modulator (SERM)	Metformin: AMP-activated protein kinase (AMPK); Clomiphene: estrogen receptor (ER)

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