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Open-label Metformin — Competitive Intelligence Brief

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

phase 3 Biguanide AMP-activated protein kinase (AMPK) Diabetes Small molecule Live · refreshed every 30 min

Target snapshot

Open-label Metformin (Open-label Metformin) — Merck Sharp & Dohme LLC. Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK).

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Open-label Metformin TARGET Open-label Metformin Merck Sharp & Dohme LLC phase 3 Biguanide AMP-activated protein kinase (AMPK)
metformin\pioglitazone\exenatide metformin\pioglitazone\exenatide The University of Texas Health Science Center at San Antonio marketed Combination antidiabetic agent (biguanide + thiazolidinedione + GLP-1 receptor agonist) Multiple: AMPK pathway (metformin), PPAR-γ (pioglitazone), GLP-1 receptor (exenatide)
metformin+ gliclazide metformin+ gliclazide GlaxoSmithKline marketed Antidiabetic combination (biguanide + sulfonylurea) Metformin: mitochondrial glycerophosphate dehydrogenase; Gliclazide: ATP-sensitive potassium channels on pancreatic beta cells
Linagliptin / Metformin Oral Tablet Linagliptin / Metformin Oral Tablet Universidad de Guanajuato marketed DPP-4 inhibitor / Biguanide combination DPP-4 (dipeptidyl peptidase-4) / AMPK pathway
Metformin discontinue Metformin discontinue University of Texas Southwestern Medical Center marketed Biguanide AMP-activated protein kinase (AMPK); hepatic glucose production
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)
metformin or sulfonylurea metformin or sulfonylurea Dr. Milan Gupta marketed Antidiabetic agents (biguanide and sulfonylurea) Metformin: AMP-activated protein kinase (AMPK) pathway; Sulfonylureas: ATP-sensitive potassium channel (KATP)

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

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Cite this brief

Drug Landscape (2026). Open-label Metformin — Competitive Intelligence Brief. https://druglandscape.com/ci/open-label-metformin. Accessed 2026-05-14.

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