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Metformin

Generic Name
Metformin
Brand Names
Actoplus Met, Avandamet, Fortamet, Glucophage, Glucovance, Glumetza, Glycon, Invokamet, Janumet, Jentadueto, Kazano, Kombiglyze, Komboglyze, Qternmet, Riomet, Segluromet, Synjardy, Trijardy, Velmetia, Xigduo, Sitagliptin / Metformin hydrochloride Accord, Vildagliptin / Metformin hydrochloride Accord, Vokanamet, Sitagliptin / Metformin hydrochloride Mylan, Efficib, Zomarist, Vipdomet, Sitagliptin / Metformin hydrochloride Sun
Drug Type
Small Molecule
Chemical Formula
C4H11N5
CAS Number
657-24-9
Unique Ingredient Identifier
9100L32L2N

Overview

Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels. Another well-known benefit of this drug is modest weight loss, making it an effective choice for obese patients type II diabetes. Metformin was first approved in Canada in 1972, and received subsequent FDA approval in the US in 1995.

Indication

Metformin immediate-release formulations Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years old with type 2 diabetes mellitus. Metformin extended-release tablet (XR) The extended-release formulation of metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Safety in children has not been determined to this date. Metformin combination products Metformin is a component of a variety of combination products with other anti-diabetic agents. It is indicated, along with diet and exercise, to improve glycemic control in adult patients with type 2 diabetes mellitus in combination with DPP-4 inhibitors (sitagliptin, linagliptin, alogliptin, or saxagliptin), in combination with SGLT2 inhibitors (canagliflozin, empagliflozin, ertugliflozin, or dapagliflozin), or in combination with pioglitazone.

Associated Conditions

  • Cardiovascular Mortality
  • End Stage Renal Disease (ESRD)
  • Hospitalizations
  • Polycystic Ovarian Syndrome (PCOS)
  • Type 2 Diabetes Mellitus
  • Decreased estimated glomerular filtration rate

Research Report

Published: May 14, 2025

Metformin Report

Name: Metformin Name (English): Metformin DrugBank ID: DB00331 Type: Small Molecule CAS Number: 657-24-9

General Information: Metformin is an oral antihyperglycemic agent of the biguanide class, primarily used in the management of type 2 diabetes mellitus. It is often considered the first-line medication for this condition, especially in overweight individuals. Metformin can also be used off-label for insulin resistance in polycystic ovary syndrome (PCOS).

Pharmacology: Metformin works by:

  • Decreasing hepatic glucose production.
  • Increasing insulin sensitivity in peripheral tissues.
  • Improving glucose uptake and utilization.
  • Increasing GDF15 secretion, which reduces appetite and caloric intake.

Indications:

  • Type 2 diabetes mellitus in adults and pediatric patients ≥10 years old, as an adjunct to diet and exercise.
  • May be used as a second-line agent for infertility in women with PCOS.
  • Investigational use for other conditions such as type 1 diabetes, obesity, and various cancers is ongoing.

Dosage and Administration: Dosage varies depending on the formulation (immediate-release or extended-release) and individual patient needs. It is typically taken with meals to reduce gastrointestinal side effects.

Contraindications:

  • Severe renal impairment (eGFR below 30 mL/min/1.73 m²)
  • Hypersensitivity to metformin
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2024/06/11
Early Phase 1
Completed
Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
2024/06/10
Phase 1
Completed
Humanis Saglık Anonim Sirketi
2024/06/07
Phase 4
Not yet recruiting
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
2024/06/06
Phase 1
Recruiting
2024/06/06
Phase 4
Recruiting
2024/06/03
Phase 4
Not yet recruiting
2024/05/24
Phase 1
Not yet recruiting
2024/05/22
Phase 1
Not yet recruiting
2024/05/16
Phase 1
Completed
2024/05/09
Not Applicable
Recruiting
Ming Lv

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-117
ORAL
500 mg in 1 1
12/21/2020
Aphena Pharma Solutions - Tennessee, LLC
71610-941
ORAL
1000 mg in 1 1
8/26/2025
Granules Pharmaceuticals Inc.
70010-064
ORAL
850 mg in 1 1
8/9/2023
Aurobindo Pharma Limited
65862-081
ORAL
500 mg in 1 1
3/16/2022
RPK Pharmaceuticals, Inc.
53002-4422
ORAL
850 mg in 1 1
2/7/2017
Laurus Labs Limited
42385-949
ORAL
1000 mg in 1 1
9/21/2023
State of Florida DOH Central Pharmacy
53808-0848
ORAL
1000 mg in 1 1
4/15/2014
Mylan Pharmaceuticals Inc.
0378-6001
ORAL
1000 mg in 1 1
5/25/2017
Northwind Pharmaceuticals
51655-562
ORAL
750 mg in 1 1
6/19/2014
direct rx
72189-064
ORAL
500 mg in 1 1
10/11/2022

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Number
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Company
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No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
APOTEX-METFORMIN 1000 metformin hydrochloride 1000 mg tablet blister pack
157214
Medicine
A
4/7/2010
APOTEX-METFORMIN 850 metformin hydrochloride 850 mg tablet blister pack
157218
Medicine
A
4/7/2010
SITAGLIPTIN/METFORMIN XR MYLAN 50/1000 sitagliptin (as phosphate)/metformin hydrochloride 50 mg/1000 mg extended release tablet bottle
443397
Medicine
A
3/20/2025
JANUMET 50 mg/1000 mg sitagliptin phosphate monohydrate/metformin HCI 50 mg/1000 mg tablet blister pack
149023
Medicine
A
4/30/2009
METFORMIN-MH XR 500 metformin hydrochloride 500 mg extended release tablet blister pack
423420
Medicine
A
8/8/2024
SITAGLIPTIN/METFORMIN 50/1000 SUN sitagliptin (as fumarate)/metformin hydrochloride 50 mg/1000 mg tablet bottle
383280
Medicine
A
3/7/2023
AURO-METFORMIN 850 metformin hydrochloride 850 mg tablets Bottle
180432
Medicine
A
11/24/2011
MEDREICH METFORMIN XR 1000 metformin hydrochloride 1000 mg extended release tablet blister pack
420750
Medicine
A
8/8/2024
Sitagliptin/Metformin Sandoz 50/1000 sitagliptin (as hydrochloride monohydrate)/metformin hydrochloride 50 mg/1000 mg film coated tablet blister pack
326500
Medicine
A
9/13/2021
TIH-METFORMIN metformin hydrochloride 500 mg tablet blister pack
335851
Medicine
A
6/23/2020

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
VAN-METFORMIN
vanc pharmaceuticals inc
02444941
Tablet - Oral
850 MG
N/A
SITAGLIPTIN-METFORMIN
sivem pharmaceuticals ulc
02529157
Tablet - Oral
500 MG
2/6/2023
M-METFORMIN
mantra pharma inc
02548275
Tablet - Oral
1000 MG
11/14/2024
METFORMIN
02229517
Tablet - Oral
850 MG
N/A
APO-DAPAGLIFLOZIN-METFORMIN
02536161
Tablet - Oral
1000 MG
12/1/2023
PRZ-SITAGLIPTIN-METFORMIN
pharmaris canada inc
02552329
Tablet - Oral
1000 MG
N/A
RATIO-METFORMIN
teva canada limited
02242974
Tablet - Oral
500 MG
1/4/2001
SANDOZ METFORMIN FC
02246820
Tablet - Oral
500 MG
12/20/2002
PMS-ROSIGLITAZONE-METFORMIN
02357925
Tablet - Oral
1000 MG
N/A
NTP-METFORMIN
nt pharma canada ltd
02361272
Tablet - Oral
850 MG
N/A

CIMA AEMPS Drug Approvals

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Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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