Rosiglitazone - PharmaKB

Avandia(rosiglitazone)

Avaglim, Avandamet, Avandaryl, Avandia, Nyracta, Venvia (rosiglitazone) is a small molecule pharmaceutical. Rosiglitazone was first approved as Avandia on 1999-05-25. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. The pharmaceutical is active against peroxisome proliferator-activated receptor gamma. In addition, it is known to target transient receptor potential cation channel subfamily M member 3, short transient receptor potential channel 5, and free fatty acid receptor 1.

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Trends

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Events Timeline

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Events

FDA approval date

EMA approval date

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Commercial

Therapeutic Areas

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

Trade Name

FDA

EMA

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Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Rosiglitazone maleate

Tradename	Company	Number	Date	Products
AVANDIA	Woodward Pharma Services	N-021071 DISCN	1999-05-25	3 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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Glimepiride

Rosiglitazone maleate

Tradename	Company	Number	Date	Products
AVANDARYL	SB Pharmco	N-021700 DISCN	2005-11-23	5 products, RLD

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Labels

FDA

EMA

Brand Name	Status	Last Update
avandamet	New Drug Application	2012-08-30
avandia	New Drug Application	2010-01-19

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

— A10BD: Combinations of oral blood glucose lowering drugs

— A10BD03: Metformin and rosiglitazone

— A10BD04: Glimepiride and rosiglitazone

— A10BG: Thiazolidinediones, blood glucose lowering drugs

— A10BG02: Rosiglitazone

HCPCS

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Clinical

Clinical Trials

229 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	—	—	1	1	—	2
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	—	1	1	—	2
Insulin resistance	D007333	EFO_0002614	E88.819	—	—	—	1	—	1

Indications Phases 3

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Indications Phases 2

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Indications Phases 1

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Indications Without Phase

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Rosiglitazone
INN	rosiglitazone
Description	Rosiglitazone is an aminopyridine and a member of thiazolidinediones. It has a role as an insulin-sensitizing drug, a ferroptosis inhibitor and an EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor. It is a conjugate acid of a rosiglitazone(1-).
Classification	Small molecule
Drug class	peroxisome proliferator activiating receptor (PPAR) agonists (thiazolidene derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1

Identifiers

PDB	—
CAS-ID	122320-73-4
RxCUI	—
ChEMBL ID	CHEMBL121
ChEBI ID	50122
PubChem CID	77999
DrugBank	DB00412
UNII ID	05V02F2KDG (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

RXRA

Organism

Homo sapiens

Gene name

RXRA

Gene synonyms

NR2B1

NCBI Gene ID

6256

Protein name

retinoic acid receptor RXR-alpha

Protein synonyms

Nuclear receptor subfamily 2 group B member 1, retinoid X nuclear receptor alpha, Retinoid X receptor alpha

Uniprot ID

P19793

Mouse ortholog

Rxra (20181)

retinoic acid receptor RXR-alpha (P28700)

Variants

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Financial

Revenue by drug

€

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Estimated US medical usage

Rosiglitazone

Glimepiride

Total medical expenditures per year (USD, in millions)

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Rosiglitazone

Metformin

Total medical expenditures per year (USD, in millions)

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Rosiglitazone

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 30,174 documents

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Safety

Black-box Warning

Black-box warning for: Avandamet, Avandia

Adverse Events

Top Adverse Reactions

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112,177 adverse events reported

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