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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
2024/10/15
Phase 4
Recruiting
2024/10/07
Early Phase 1
Completed
Zhongnan Hospital
2024/09/26
Phase 4
Completed
Zhibin Xu
2024/09/25
Phase 2
Recruiting
2024/09/10
Not Applicable
Not yet recruiting
2024/08/28
Phase 3
Recruiting
2024/08/26
Phase 3
Recruiting
2024/08/05
Phase 2
Recruiting
Hospital Municipal São José
2024/07/29
Phase 2
Recruiting
Diana Jalal
2024/07/26
Phase 1
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
RedPharm Drug, Inc.
67296-1527
ORAL
500 mg in 1 1
1/21/2022
Bryant Ranch Prepack
71335-2291
ORAL
1000 mg in 1 1
3/31/2019
Micro Labs Limited
42571-333
ORAL
500 mg in 1 1
1/12/2023
RedPharm Drug, Inc.
67296-0712
ORAL
500 mg in 1 1
1/19/2022
NuCare Pharmaceuticals, Inc.
68071-1774
ORAL
500 mg in 1 1
2/11/2021
A-S Medication Solutions
50090-6485
ORAL
500 mg in 1 1
11/5/2022
REMEDYREPACK INC.
70518-2920
ORAL
750 mg in 1 1
2/9/2022
Westminster Pharmaceuticals, LLC
69367-182
ORAL
1000 mg in 1 1
4/28/2020
Amneal Pharmaceuticals NY LLC
69238-2126
ORAL
750 mg in 1 1
8/31/2023
Qingdao BAHEAL Pharmaceutical Co., Ltd.
70247-019
ORAL
500 mg in 1 1
1/22/2024

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
JARDIANCE DUO FILM COATED TABLET 5MG/500MG
SIN15064P
TABLET, FILM COATED
500mg
8/3/2016
XIGDUO XR TABLETS 5MG/1000MG
SIN15080P
TABLET, FILM COATED, EXTENDED RELEASE
1000mg
8/30/2016
JARDIANCE DUO FILM COATED TABLET 12.5MG/500MG
SIN15063P
TABLET, FILM COATED
500mg
8/3/2016
Galvus Met Tablet 50mg/500mg
SIN13952P
TABLET, FILM COATED
500.0mg
5/3/2011
XIGDUO XR TABLETS 5MG/500MG
SIN15077P
TABLET, FILM COATED, EXTENDED RELEASE
500mg
8/30/2016
JARDIANCE DUO FILM COATED TABLET 12.5MG/850MG
SIN15062P
TABLET, FILM COATED
850mg
8/3/2016
SITAGLIPTIN-METFORMIN SANDOZ FILM COATED TABLET 50MG/1000MG
SIN17119P
TABLET, FILM COATED
1000mg
10/24/2024
SITAGLIPTIN-METFORMIN SANDOZ FILM COATED TABLET 50MG/850MG
SIN17120P
TABLET, FILM COATED
850mg
10/24/2024
SITAGLIPTIN-METFORMIN SANDOZ FILM COATED TABLET 50MG/500MG
SIN17121P
TABLET, FILM COATED
500mg
10/24/2024

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
METFORMIN GPPL XR 500 metformin hydrochloride 500 mg modified release tablet blister pack
232664
Medicine
A
9/10/2015
JANUMET XR 100/1000 sitagliptin (as phosphate monohydrate)/metformin hydrochloride 100 mg/1000 mg extended release tablet bottle
205318
Medicine
A
11/1/2013
KOMBIGLYZE XR 5/500 tablets 5 mg saxagliptin (as hydrochloride) immediate release and 500 mg metformin hydrochloride modified release
202209
Medicine
A
10/10/2013
TRAJENTAMET 2.5 mg/1000 mg linagliptin 2.5 mg / metformin hydrochloride 1000 mg film-coated tablet bottle
195090
Medicine
A
5/21/2013
APX-METFORMIN metformin hydrochloride 850 mg tablet bottle
284954
Medicine
A
7/19/2017
TN-METFORMIN metformin hydrochloride 500 mg tablet blister pack
284965
Medicine
A
7/19/2017
METFORMIN-ME XR 500 metformin hydrochloride 500 mg extended release tablet blister pack
423414
Medicine
A
8/8/2024
METFORMIN-MC XR 500 metformin hydrochloride 500 mg extended release tablet blister pack
423417
Medicine
A
8/8/2024
Metformin-WGR XR metformin hydrochloride 500 mg modified release tablet blister pack
278176
Medicine
A
9/5/2016
Metformin-WGR XR metformin hydrochloride 1000 mg modified release tablet blister pack
278175
Medicine
A
9/5/2016

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SYNJARDY
boehringer ingelheim (canada) ltd ltee
02456605
Tablet - Oral
500 MG
8/3/2016
SYNJARDY
boehringer ingelheim (canada) ltd ltee
02456613
Tablet - Oral
850 MG
8/3/2016
PRZ-SITAGLIPTIN-METFORMIN
pharmaris canada inc
02552310
Tablet - Oral
850 MG
N/A
MYLAN-METFORMIN
Mylan Pharmaceuticals ULC
02229656
Tablet - Oral
850 MG
5/12/1997
AVA-METFORMIN
avanstra inc
02364506
Tablet - Oral
500 MG
9/15/2011
APO-METFORMIN ER
02460653
Tablet (Extended-Release) - Oral
1000 MG
10/2/2017
APO-SITAGLIPTIN-METFORMIN
02435772
Tablet - Oral
500 MG
N/A
ORB-METFORMIN
orbus pharma inc
02246613
Tablet - Oral
500 MG
N/A
M-METFORMIN
mantra pharma inc
02547767
Tablet - Oral
500 MG
11/14/2024
METFORMIN
Cobalt Pharmaceuticals Company
02343606
Tablet - Oral
500 MG
N/A

CIMA AEMPS Drug Approvals

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Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

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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