Glucophage, Avandamet(metformin)

Actoplus Met, Avandamet, Competact, Ebymect, Efficib, Eucreas, Fortamet, Glucovance, Glumetza, Icandra, Invokamet, Janumet, Jentadueto, Kazano, Kombiglyze, Komboglyze, Metaglip, Prandimet, Qternmet, Qtrilmet, Ristfor, Segluromet, Synjardy, Trijardy, Velmetia, Vipdomet, Vokanamet, Xigduo, Zomarist (metformin) is a small molecule pharmaceutical. Metformin was first approved as Glucophage on 1995-03-03. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. It is known to target solute carrier family 22 member 2, 5'-AMP-activated protein kinase subunit beta-1, solute carrier family 22 member 3, multidrug and toxin extrusion protein 1, multidrug and toxin extrusion protein 2, and cytochrome P450 3A4.

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SARS-CoV-2 Interaction

COVID-19

BMS

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nutritional and metabolic diseases	D009750
endocrine system diseases	D004700

Trade Name

FDA

EMA

Fortamet, Glumetza (generic drugs available since 2002-01-24, discontinued: Glucophage, Riomet)

Combinations

Actoplus met, Invokamet, Janumet, Jentadueto, Kazano, Kombiglyze, Segluromet, Synjardy, Trijardy, Xigduo (generic drugs available since 2002-01-24, discontinued: Avandamet, Glucovance, Metaglip, Prandimet, Qternmet)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Alogliptin benzoate

Metformin hydrochloride

Tradename	Company	Number	Date	Products
KAZANO	Takeda	N-203414 RX	2013-01-25	2 products, RLD, RS

Canagliflozin

Metformin hydrochloride

Tradename	Company	Number	Date	Products
INVOKAMET	Johnson & Johnson	N-204353 RX	2014-08-08	4 products, RLD, RS
INVOKAMET XR	Johnson & Johnson	N-205879 RX	2016-09-20	4 products, RLD, RS

Dapagliflozin

Metformin hydrochloride

Tradename	Company	Number	Date	Products
XIGDUO XR	AstraZeneca	N-205649 RX	2014-10-29	5 products, RLD, RS

Dapagliflozin

Metformin hydrochloride

Saxagliptin hydrochloride

Tradename	Company	Number	Date	Products
QTERNMET XR	AstraZeneca	N-210874 DISCN	2019-05-02	4 products, RLD

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Empagliflozin

Linagliptin

Metformin hydrochloride

Tradename	Company	Number	Date	Products
TRIJARDY XR	Boehringer Ingelheim	N-212614 RX	2020-01-27	4 products, RLD, RS

Empagliflozin

Metformin hydrochloride

Tradename	Company	Number	Date	Products
SYNJARDY	Boehringer Ingelheim	N-206111 RX	2015-08-26	4 products, RLD, RS
SYNJARDY XR	Boehringer Ingelheim	N-208658 RX	2016-12-09	4 products, RLD, RS

Ertugliflozin

Metformin hydrochloride

Tradename	Company	Number	Date	Products
SEGLUROMET	Merck Sharp & Dohme	N-209806 RX	2017-12-19	4 products, RLD, RS

Glipizide

Metformin hydrochloride

Tradename	Company	Number	Date	Products
METAGLIP	Bristol Myers Squibb	N-021460 DISCN	2002-10-21	3 products, RLD

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Glyburide

Metformin hydrochloride

Tradename	Company	Number	Date	Products
GLUCOVANCE	Bristol Myers Squibb	N-021178 DISCN	2000-07-31	3 products, RLD

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Linagliptin

Metformin hydrochloride

Tradename	Company	Number	Date	Products
JENTADUETO	Boehringer Ingelheim	N-201281 RX	2012-01-30	3 products, RLD, RS
JENTADUETO XR	Boehringer Ingelheim	N-208026 RX	2016-05-27	2 products, RLD, RS

Metformin hydrochloride

Tradename	Company	Number	Date	Products
FORTAMET	Andrx Corporation	N-021574 RX	2004-04-27	1 products, RLD
GLUMETZA	Santarus	N-021748 RX	2005-06-03	2 products, RLD, RS

Show 5 discontinued

Metformin hydrochloride

Pioglitazone hydrochloride

Tradename	Company	Number	Date	Products
ACTOPLUS MET	Takeda	N-021842 RX	2005-08-29	1 products, RLD, RS

Show 2 discontinued

Metformin hydrochloride

Repaglinide

Tradename	Company	Number	Date	Products
PRANDIMET	Novo Nordisk	N-022386 DISCN	2008-06-23	2 products, RLD

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Metformin hydrochloride

Rosiglitazone maleate

Tradename	Company	Number	Date	Products
AVANDAMET	SB Pharmco	N-021410 DISCN	2002-10-10	5 products, RLD

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Metformin hydrochloride

Saxagliptin hydrochloride

Tradename	Company	Number	Date	Products
KOMBIGLYZE XR	AstraZeneca	N-200678 RX	2010-11-05	3 products, RLD

Metformin hydrochloride

Sitagliptin phosphate

Tradename	Company	Number	Date	Products
JANUMET XR	Merck Sharp & Dohme	N-202270 RX	2012-02-02	3 products, RLD, RS
JANUMET	Merck Sharp & Dohme	N-022044 RX	2007-03-30	2 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
actoplus met	New Drug Application	2021-01-13
avandamet	New Drug Application	2012-08-30
fortamet	New Drug Application	2021-03-02
glucovance	New Drug Application	2012-04-23
glumetza	New Drug Application	2019-08-01
invokamet invokamet xr	New Drug Application	2022-10-20
janumet	New Drug Application	2023-06-19
jentadueto	New Drug Application	2022-04-27
kazano	New Drug Application	2021-04-27
kombiglyze	New Drug Application	2019-10-24

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
type 2 diabetes mellitus	EFO_0001360	D003924	E11

Agency Specific

FDA

EMA

Expiration	Code
ERTUGLIFLOZIN / METFORMIN HYDROCHLORIDE, SEGLUROMET, MSD SUB MERCK
2024-09-17	M-275
METFORMIN HYDROCHLORIDE / SITAGLIPTIN PHOSPHATE, JANUMET, MSD SUB MERCK
2024-06-04	PED
2023-12-04	M-187
2023-02-12	PED
METFORMIN HYDROCHLORIDE / SITAGLIPTIN PHOSPHATE, JANUMET XR, MERCK SHARP DOHME
2024-06-04	PED
2023-12-04	M-187
2023-02-12	PED
LINAGLIPTIN / METFORMIN HYDROCHLORIDE, JENTADUETO, BOEHRINGER INGELHEIM
2023-03-30	M-252
LINAGLIPTIN / METFORMIN HYDROCHLORIDE, JENTADUETO XR, BOEHRINGER INGELHEIM
2023-03-30	M-252

Patent Expiration

Patent	Expires	Flag	FDA Information
Metformin Hydrochloride, Riomet Er, Sun Pharm
9962336	2035-05-01	DP
Empagliflozin / Linagliptin / Metformin Hydrochloride, Trijardy Xr, Boehringer Ingelheim
9949998	2034-06-11		U-2290, U-2731
10258637	2034-04-03		U-2290, U-2731
11090323	2034-04-03		U-3192, U-3193
10596120	2032-03-07	DP	U-2775, U-2776, U-2790, U-2792
11564886	2032-03-07	DP	U-3531
10406172	2030-06-15	DP	U-2733
9155705	2030-05-21	DP
8551957	2029-10-14	DP	U-2730
9415016	2029-04-02	DP
10022379	2029-04-02		U-2339, U-2732
7579449	2028-08-01	DP
7713938	2027-04-15	DS, DP
8883805	2025-11-26	DP
7407955	2025-05-02	DS, DP
8119648	2023-08-12		U-802, U-1652
8178541	2023-08-12	DP	U-775, U-1652, U-1853
Empagliflozin / Metformin Hydrochloride, Synjardy, Boehringer Ingelheim
9949997	2034-05-17		U-3532, U-3533
10610489	2030-09-30	DP
Linagliptin / Metformin Hydrochloride, Jentadueto Xr, Boehringer Ingelheim
9555001	2033-03-06	DP	U-1967, U-1968
9173859	2027-05-04	DP	U-1503
Dapagliflozin / Metformin Hydrochloride, Xigduo Xr, Astrazeneca Ab
9616028	2030-11-12	DP
8685934	2030-05-26		U-1522
7919598	2029-12-16	DP
8501698	2027-06-20	DP	U-493
6515117	2025-10-04	DS, DP	U-493
Ertugliflozin / Metformin Hydrochloride, Segluromet, Msd Sub Merck
9308204	2030-10-21	DP
9439902	2030-10-21		U-2214
8080580	2030-07-13	DS, DP	U-2214
Canagliflozin / Metformin Hydrochloride, Invokamet, Janssen Pharms
11576894	2030-07-06	DP
7943582	2029-02-26	DS, DP	U-493, U-2441, U-2632
8513202	2027-12-03	DS, DP	U-493, U-2441, U-2632
7943788	2027-07-14	DS, DP
8222219	2025-04-11		U-493, U-2441, U-2632
8785403	2024-07-30	DP
Linagliptin / Metformin Hydrochloride, Jentadueto, Boehringer Ingelheim
8846695	2030-06-04		U-1503
10973827	2029-04-02	DP
8673927	2027-05-04		U-1503
Alogliptin Benzoate / Metformin Hydrochloride, Kazano, Takeda Pharms Usa
8900638	2029-05-24	DP
7807689	2028-06-27	DS, DP	U-1337
8288539	2025-06-24	DP
8173663	2025-03-15		U-1338
Metformin Hydrochloride / Pioglitazone Hydrochloride, Actoplus Met, Takeda Pharms Usa
9320714	2029-02-03	DP
9101660	2027-01-22	DP

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ATC Codes

A: Alimentary tract and metabolism drugs

— A10: Drugs used in diabetes

— A10B: Blood glucose lowering drugs, excl. insulins

— A10BA: Biguanide blood glucose lower drugs

— A10BA02: Metformin

— A10BD: Combinations of oral blood glucose lowering drugs

— A10BD02: Metformin and sulfonylureas

— A10BD03: Metformin and rosiglitazone

— A10BD05: Metformin and pioglitazone

— A10BD07: Metformin and sitagliptin

— A10BD08: Metformin and vildagliptin

— A10BD10: Metformin and saxagliptin

— A10BD11: Metformin and linagliptin

— A10BD13: Metformin and alogliptin

— A10BD14: Metformin and repaglinide

— A10BD15: Metformin and dapagliflozin

— A10BD16: Metformin and canagliflozin

— A10BD17: Metformin and acarbose

— A10BD18: Metformin and gemigliptin

— A10BD20: Metformin and empagliflozin

— A10BD22: Metformin and evogliptin

— A10BD23: Metformin and ertugliflozin

— A10BD25: Metformin, saxagliptin and dapagliflozin

— A10BD26: Metformin and lobeglitazone

— A10BD27: Metformin, linagliptin and empagliflozin

HCPCS

No data

Clinical

Clinical Trials

1835 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	88	100	264	164	76	670
Healthy volunteers/patients	—			165	1	—	1	8	175
Polycystic ovary syndrome	D011085	EFO_0000660	E28.2	12	14	22	42	43	127
Obesity	D009765	EFO_0001073	E66.9	7	18	9	22	21	73
Insulin resistance	D007333	EFO_0002614		5	15	15	19	12	61
Diabetes mellitus	D003920	EFO_0000400	E08-E13	8	6	16	14	10	53
Gestational diabetes	D016640	HP_0009800	O24.4	2	5	16	9	8	36
Prediabetic state	D011236	EFO_1001121	R73.03	3	6	8	15	5	35
Metabolic syndrome	D024821	EFO_0000195	E88.81	—	12	6	8	8	33
Prostatic neoplasms	D011471		C61	5	25	3	1	1	32

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	10	26	2	—	5	42
Neoplasms	D009369		C80	10	4	1	—	1	15
Endometrial neoplasms	D016889	EFO_0004230		4	8	1	—	3	15
Non-small-cell lung carcinoma	D002289			—	11	1	—	—	12
Colorectal neoplasms	D015179			1	9	1	—	1	12
Liver neoplasms	D008113	EFO_1001513	C22.0	1	5	2	—	—	8
Chronic renal insufficiency	D051436		N18	—	4	2	—	2	7
Chronic periodontitis	D055113	EFO_0006343	K05.3	—	6	5	—	—	6
Hyperandrogenism	D017588			1	3	1	—	1	5
Acinar cell carcinoma	D018267			1	3	1	—	—	4

Show 45 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	6	9	—	—	2	16
Lung neoplasms	D008175		C34.90	2	7	—	—	—	9
Melanoma	D008545			3	7	—	—	—	8
Glioblastoma	D005909	EFO_0000515		2	5	—	—	—	7
Squamous cell carcinoma of head and neck	D000077195			3	3	—	—	1	6
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	2	3	—	—	1	5
Colonic neoplasms	D003110		C18	1	3	—	—	—	4
Adenocarcinoma	D000230			—	4	—	—	—	4
Rectal neoplasms	D012004			—	3	—	—	1	4
Ovarian epithelial carcinoma	D000077216			2	2	—	—	—	4

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Therapeutic equivalency	D013810			6	—	—	—	2	8
Pharmacokinetics	D010599			5	—	—	—	—	5
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	1	—	—	—	3	4
Drug interactions	D004347			3	—	—	—	—	3
Hyperlipidemias	D006949	EFO_0003774	E78.5	3	—	—	—	—	3
Weight loss	D015431	HP_0001824		1	—	—	—	1	2
Metabolism	D008660	GO_0008152		1	—	—	—	1	2
Fatigue	D005221	HP_0012378	R53.83	1	—	—	—	1	2
Lymphoma	D008223		C85.9	2	—	—	—	—	2
Fasting	D005215	EFO_0002756		2	—	—	—	—	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pre-eclampsia	D011225	EFO_0000668	O14	—	—	—	—	3	3
Disease-free survival	D018572	EFO_0000409		—	—	—	—	2	2
Open-angle glaucoma	D005902	EFO_0004190	H40.1	—	—	—	—	1	1
Postoperative pain	D010149		G89.18	—	—	—	—	1	1
Microbiota	D064307			—	—	—	—	1	1
Fertility	D005298			—	—	—	—	1	1
Uveitis	D014605	EFO_1001231	H20.9	—	—	—	—	1	1
Fibrosis	D005355			—	—	—	—	1	1
Psoriatic arthritis	D015535	EFO_0003778	L40.5	—	—	—	—	1	1
Prehypertension	D058246			—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	METFORMIN
INN	metformin
Description	Metformin is a member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1. It has a role as a hypoglycemic agent, a xenobiotic, an environmental contaminant and a geroprotector. It is functionally related to a biguanide. It is a conjugate base of a metformin(1+).
Classification	Small molecule
Drug class	hypoglycemics (phenformin type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CN(C)C(=N)NC(=N)N

Identifiers

PDB	5G5J
CAS-ID	657-24-9
RxCUI	6809
ChEMBL ID	CHEMBL1431
ChEBI ID	6801
PubChem CID	4091
DrugBank	DB00331
UNII ID	9100L32L2N (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

SLC22A2

PRKAB1

SLC22A3

SLC47A1

SLC47A2

CYP3A4

Organism

Homo sapiens

Gene name

SLC22A2

Gene synonyms

OCT2

NCBI Gene ID

6582

Protein name

solute carrier family 22 member 2

Protein synonyms

hOCT2, Organic cation transporter 2, solute carrier family 22 (organic cation transporter), member 2

Uniprot ID

Q9NQB9

Mouse ortholog

Slc22a2 (20518)

solute carrier family 22 member 2 (Q8K4X8)

Variants

Clinical Variant

No data

Financial

Janumet - Merck Sharp & Dohme

€

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Metformin - Amneal Pharmaceuticals

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 97,467 documents

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Safety

Black-box Warning

Black-box warning for: Actoplus met, Avandamet , Fortamet, Glumetza, Invokamet invokamet xr, Janumet, Jentadueto, Kazano, Kombiglyze, Riomet, Segluromet, Synjardy, Trijardy xr, Xigduo

Adverse Events

Top Adverse Reactions

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1,218 adverse events reported

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MATERIALS

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