Glyburide - PharmaKB

Glyburide

Diabeta, Glyburide, Glynase (glyburide) is a small molecule pharmaceutical. Glyburide was first approved as Micronase on 1984-05-01. It is used to treat type 2 diabetes mellitus in the USA. The pharmaceutical is active against ATP-sensitive inward rectifier potassium channel 11. In addition, it is known to target ATP-sensitive inward rectifier potassium channel 8, cystic fibrosis transmembrane conductance regulator, and solute carrier organic anion transporter family member 2B1.

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Financial

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Events Timeline

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion date

Results first post date

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Commercial

Therapeutic Areas

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

Trade Name

FDA

EMA

Diabeta, Glyburide, Glynase (discontinued: Glyburide, Glynase, Micronase)

Combinations

Glyburide metformin (discontinued: Glucovance, Glyburide metformin)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Glyburide

Tradename	Company	Number	Date	Products
GLYNASE	Pfizer	N-020051 RX	1992-03-04	3 products, RLD
DIABETA	Sanofi	N-017532 RX	1984-05-01	3 products, RLD, RS

Show 3 discontinued

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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Labels

FDA

EMA

Brand Name	Status	Last Update
glucovance	New Drug Application	2012-04-23
glyburase		2006-09-19
glyburide	ANDA	2024-10-28
glyburide and metformin	ANDA	2011-12-20
glyburide and metformin hydrochloride	ANDA	2024-08-20
glyburide-metformin hydrochloride	ANDA	2024-10-21

Indications

FDA

EMA

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

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

A: Alimentary tract and metabolism drugs

— A10: Drugs used in diabetes

— A10B: Blood glucose lowering drugs, excl. insulins

— A10BB: Sulfonylureas for blood glucose lowering

— A10BB01: Glibenclamide

HCPCS

No data

Clinical

Clinical Trials

138 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes mellitus	D003920	HP_0000819	E08-E13	5	9	23	22	18	74
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	4	5	16	18	18	61
Gestational diabetes	D016640	HP_0009800	O24.4	2	1	3	7	5	17
Hypertension	D006973	EFO_0000537	I10	—	—	—	2	2	4
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	—	1	1	2	1	4
Cardiovascular diseases	D002318	HP_0001626	—	—	—	—	1	2	3
Hemorrhage	D006470	MP_0001914	R58	—	—	—	2	1	3
Vascular stiffness	D059289	—	—	—	—	—	1	1	2
Subarachnoid hemorrhage	D013345	EFO_0000713	I60	—	—	—	2	—	2
Pregnancy in diabetics	D011254	—	O24.91	—	—	—	1	1	2

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	12	—	1	—	2	15
Stroke	D020521	EFO_0000712	I63.9	2	3	2	—	—	5
Hypoglycemia	D007003	HP_0001943	E16.2	—	3	1	—	2	5
Reperfusion injury	D015427	—	—	—	—	1	—	2	3
Heart failure	D006333	HP_0001635	I50	—	—	1	—	2	3
Edema	D004487	HP_0000969	R60.9	1	2	1	—	—	3
Pregnancy	D011247	EFO_0002950	Z33.1	—	—	2	—	1	3
Neoplasm metastasis	D009362	EFO_0009708	—	1	1	1	—	—	2
Brain edema	D001929	EFO_1000845	G93.6	1	1	1	—	—	2
Infarction	D007238	EFO_0009463	—	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Traumatic brain injuries	D000070642	—	S06	2	2	—	—	—	3
Brain injuries	D001930	—	S06.9	2	2	—	—	—	3
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	1	—	—	1	2
Wounds and injuries	D014947	—	T14.8	2	1	—	—	—	2
Spinal cord injuries	D013119	EFO_1001919	—	2	1	—	—	—	2
Ischemic stroke	D000083242	—	—	1	2	—	—	—	2
Hyperglycemia	D006943	HP_0003074	R73.9	—	2	—	—	—	2
Brain neoplasms	D001932	EFO_0003833	C71	1	1	—	—	—	1
Contusions	D003288	—	T14.8	—	1	—	—	—	1
Brain contusion	D000070624	—	—	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Angina pectoris	D000787	EFO_0003913	I20	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Headache	D006261	HP_0002315	R51	—	—	—	—	3	3
Ischemia	D007511	EFO_0000556	—	—	—	—	—	2	2
Cerebrovascular circulation	D002560	—	—	—	—	—	—	2	2
Pancreatitis	D010195	HP_0001733	K85	—	—	—	—	1	1
Pancreatic neoplasms	D010190	EFO_0003860	C25	—	—	—	—	1	1
Cerebral hemorrhage	D002543	—	—	—	—	—	—	1	1
Neoplasms	D009369	—	C80	—	—	—	—	1	1
Inflammation	D007249	MP_0001845	—	—	—	—	—	1	1
Latent autoimmune diabetes in adults	D000071698	—	—	—	—	—	—	1	1
Migraine disorders	D008881	EFO_0003821	G43	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Glyburide
INN	glibenclamide
Description	Glyburide is an N-sulfonylurea that is acetohexamide in which the acetyl group is replaced by a 2-(5-chloro-2-methoxybenzamido)ethyl group. It has a role as a hypoglycemic agent, an anti-arrhythmia drug, an EC 2.7.1.33 (pantothenate kinase) inhibitor and an EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor. It is a N-sulfonylurea and a member of monochlorobenzenes.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccc(Cl)cc1C(=O)NCCc1ccc(S(=O)(=O)NC(=O)NC2CCCCC2)cc1

Identifiers

PDB	—
CAS-ID	10238-21-8
RxCUI	—
ChEMBL ID	CHEMBL472
ChEBI ID	5441
PubChem CID	3488
DrugBank	DB01016
UNII ID	SX6K58TVWC (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

SLCO2B1

AKR1C1

Organism

Homo sapiens

Gene name

SLCO2B1

Gene synonyms

KIAA0880, OATP2B1, OATPB, SLC21A9

NCBI Gene ID

11309

Protein name

solute carrier organic anion transporter family member 2B1

Protein synonyms

OATP-B, OATP-RP2, OATP2B1, OATPRP2, Organic anion transporter B, Organic anion transporter polypeptide-related protein 2, Organic anion transporting polypeptide 2B1, solute carrier family 21 (organic anion transporter), member 9, Solute carrier family 21 member 9

Uniprot ID

O94956

Mouse ortholog

Slco2b1 (101488)

solute carrier organic anion transporter family member 2B1 (Q8BXB6)

Variants

No data

Financial

Revenue by drug

€

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No data

Estimated US medical usage

Glyburide

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Glyburide

Metformin

Total medical expenditures per year (USD, in millions)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 19,042 documents

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Safety

Black-box Warning

Black-box warning for: Glyburide and metformin hydrochloride, Glyburide-metformin hydrochloride

Adverse Events

Top Adverse Reactions

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6,693 adverse events reported

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