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Drug ReportsPioglitazone
Actos, Glustin(pioglitazone)
/ Pioglitazone, Actoplus Met, Actos, Competact, Duetact, Incresync, Oseni, Pioglitazone, Tandemact (pioglitazone) is a small molecule pharmaceutical. Pioglitazone was first approved as Actos on 1999-07-15. 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.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
Trade Name
FDA
EMA
Actos, Pioglitazone (discontinued: Pioglitazone)
Combinations
Actoplus met, Duetact, Oseni, Pioglitazone glimepiride, Pioglitazone metformin (discontinued: Actoplus met, Oseni, Pioglitazone metformin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Metformin hydrochloride
+
Pioglitazone hydrochloride
Tradename
Company
Number
Date
Products
ACTOPLUS METTakedaN-021842 RX2005-08-29
1 products, RLD, RS
Show 2 discontinued
Pioglitazone hydrochloride
Tradename
Company
Number
Date
Products
ACTOSTakedaN-021073 RX1999-07-15
3 products, RLD, RS
Glimepiride
+
Pioglitazone hydrochloride
Tradename
Company
Number
Date
Products
DUETACTTakedaN-021925 RX2006-07-28
2 products, RLD
Alogliptin benzoate
+
Pioglitazone hydrochloride
Tradename
Company
Number
Date
Products
OSENITakedaN-022426 RX2013-01-25
4 products, RLD
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
actoplus metNew Drug Application2025-03-27
actosNew Drug Application2025-03-28
alogliptin and pioglitazoneNDA authorized generic2024-08-13
duetactNew Drug Application2025-03-27
oseniNew Drug Application2025-02-28
pioglitazoneANDA2025-05-17
pioglitazone and glimepirideNDA authorized generic2021-12-16
pioglitazone and metforminANDA2016-11-23
pioglitazone hydrochlorideANDA2025-05-17
pioglitazone hydrochloride and metformin hydrochlorideANDA2025-02-27
Show 1 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Alogliptin Benzoate / Pioglitazone Hydrochloride, Oseni, Takeda Pharms Usa
86370792029-06-04DP
78076892028-06-27DS, DPU-1337
81736632025-03-15U-1338
82885392025-03-15DP
Metformin Hydrochloride / Pioglitazone Hydrochloride, Actoplus Met, Takeda Pharms Usa
93207142029-02-03DP
91016602027-01-22DP
Glimepiride / Pioglitazone Hydrochloride, Duetact, Takeda Pharms Usa
80711302028-06-08DP
77001282027-01-30DP
Metformin Hydrochloride / Pioglitazone Hydrochloride, Actoplus Met Xr, Takeda Pharms Usa
77856272026-07-31DP
79599462026-07-31DP
84703682023-09-19DP
86689312023-09-19DP
90609412023-09-19DP
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
— A10BD05: Metformin and pioglitazone
— A10BD06: Glimepiride and pioglitazone
— A10BD09: Pioglitazone and alogliptin
— A10BD12: Pioglitazone and sitagliptin
— A10BG: Thiazolidinediones, blood glucose lowering drugs
— A10BG03: Pioglitazone
HCPCS
No data
Clinical
Clinical Trials
551 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePioglitazone
INNpioglitazone
Description
Pioglitazone is a member of the class of thiazolidenediones that is 1,3-thiazolidine-2,4-dione substituted by a benzyl group at position 5 which in turn is substituted by a 2-(5-ethylpyridin-2-yl)ethoxy group at position 4 of the phenyl ring. It exhibits hypoglycemic activity. It has a role as an insulin-sensitizing drug, an EC 2.7.1.33 (pantothenate kinase) inhibitor, a xenobiotic, an EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor, a ferroptosis inhibitor, a cardioprotective agent, a PPARgamma agonist, an antidepressant, a geroprotector and a hypoglycemic agent. It is a member of thiazolidinediones, an aromatic ether and a member of pyridines.
Classification
Small molecule
Drug classperoxisome proliferator activiating receptor (PPAR) agonists (thiazolidene derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Identifiers
PDB—
CAS-ID111025-46-8
RxCUI—
ChEMBL IDCHEMBL595
ChEBI ID8228
PubChem CID4829
DrugBankDB01132
UNII IDX4OV71U42S (ChemIDplus, GSRS)
Target
Agency Approved
PPARG
PPARG
Organism
Homo sapiens
Gene name
PPARG
Gene synonyms
NR1C3
NCBI Gene ID
5468
Protein name
peroxisome proliferator-activated receptor gamma
Protein synonyms
Nuclear receptor subfamily 1 group C member 3, peroxisome proliferator-activated receptor-gamma 5, peroxisome proliferator-activated receptor-gamma splicing, PPAR-gamma
Uniprot ID
Q96J12
Mouse ortholog
Pparg (19016)
peroxisome proliferator-activated receptor gamma (P37238)
Alternate
TRPM3
TRPM3
Organism
Homo sapiens
Gene name
TRPM3
Gene synonyms
KIAA1616, LTRPC3
NCBI Gene ID
80036
Protein name
transient receptor potential cation channel subfamily M member 3
Protein synonyms
Long transient receptor potential channel 3, LTrpC-3, LTrpC3, Melastatin-2, MLSN2
Uniprot ID
Q9HCF6
Mouse ortholog
—
—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Pioglitazone
+
Glimepiride
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Pioglitazone
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Metformin
Total medical expenditures per year (USD, in millions)
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Pioglitazone
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 30,345 documents
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Safety
Black-box Warning
Black-box warning for: Actoplus met, Actos, Alogliptin and pioglitazone, Duetact, Oseni, Pioglitazone, Pioglitazone and glimepiride, Pioglitazone and metformin, Pioglitazone hydrochloride, Pioglitazone hydrochloride and metformin hydrochloride, Pioglitazonehydrochloride
Adverse Events
Top Adverse Reactions
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22,209 adverse events reported
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