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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Actos, Pioglitazone (discontinued: Pioglitazone)
CombinationsActoplus 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
Pioglitazone hydrochloride
Glimepiride
+
Pioglitazone hydrochloride
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| actoplus met | New Drug Application | 2025-03-27 |
| actos | New Drug Application | 2025-03-28 |
| alogliptin and pioglitazone | NDA authorized generic | 2025-07-28 |
| duetact | New Drug Application | 2025-03-27 |
| oseni | New Drug Application | 2025-02-28 |
| pioglitazole and metformin hydrochloride | ANDA | 2025-05-06 |
| pioglitazone | ANDA | 2026-02-11 |
| pioglitazone and glimepiride | NDA authorized generic | 2025-12-12 |
| pioglitazone and metformin | ANDA | 2016-11-23 |
| pioglitazone and metformin hydrochloride | ANDA | 2025-12-03 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Alogliptin Benzoate / Pioglitazone Hydrochloride, Oseni, Takeda Pharms Usa | |||
| 8637079 | 2029-06-04 | DP | |
| 7807689 | 2028-06-27 | DS, DP | U-1337 |
| 8173663 | 2025-03-15 | U-1338 | |
| 8288539 | 2025-03-15 | DP | |
| Metformin Hydrochloride / Pioglitazone Hydrochloride, Actoplus Met, Takeda Pharms Usa | |||
| 9320714 | 2029-02-03 | DP | |
| 9101660 | 2027-01-22 | DP | |
| Glimepiride / Pioglitazone Hydrochloride, Duetact, Takeda Pharms Usa | |||
| 8071130 | 2028-06-08 | DP | |
| 7700128 | 2027-01-30 | DP | |
| Metformin Hydrochloride / Pioglitazone Hydrochloride, Actoplus Met Xr, Takeda Pharms Usa | |||
| 7785627 | 2026-07-31 | DP | |
| 7959946 | 2026-07-31 | DP | |
| 8470368 | 2023-09-19 | DP | |
| 8668931 | 2023-09-19 | DP | |
| 9060941 | 2023-09-19 | DP | |
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
558 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 | — | 8 | 20 | 15 | 14 | 55 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 7 | 20 | 11 | 5 | 41 |
| Dyslipidemias | D050171 | — | — | — | 4 | 12 | 4 | 1 | 21 |
| Glucose metabolism disorders | D044882 | — | — | — | 4 | 10 | 5 | 1 | 20 |
| Lipoatrophic diabetes mellitus | D003923 | EFO_0007346 | — | — | 3 | 6 | 3 | 1 | 13 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 2 | 1 | 1 | — | 4 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 2 | 1 | 1 | — | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | 2 | — | 1 | — | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | 1 | — | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | — | 1 | — | 2 |
Show 5 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 2 | — | — | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 2 | — | — | 3 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | 2 | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 1 | — | 1 | 2 |
| Hyperglycemia | D006943 | — | R73.9 | — | — | 1 | — | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 1 | — | — | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 1 | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
| Weight gain | D015430 | — | — | — | — | 1 | — | — | 1 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | — | 1 | — | — | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | — | — | — | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | 1 | — | — | — | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | 1 | — | — | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | — | — | 1 |
| Respiratory sounds | D012135 | — | R06.1 | — | 1 | — | — | — | 1 |
| Overweight | D050177 | — | E66.3 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | — | — | — | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | 1 | — | — | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
| Lipodystrophy | D008060 | — | E88.1 | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | — | — | 1 | 1 |
| Nephrolithiasis | D053040 | — | N20.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pioglitazone |
| INN | pioglitazone |
| 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 class | peroxisome proliferator activiating receptor (PPAR) agonists (thiazolidene derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1 |
Identifiers
| PDB | — |
| CAS-ID | 111025-46-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL595 |
| ChEBI ID | 8228 |
| PubChem CID | 4829 |
| DrugBank | DB01132 |
| UNII ID | X4OV71U42S (ChemIDplus, GSRS) |
Target
Agency Approved
PPARG
PPARG
Organism
Homo sapiens
Gene name
PPARG
Gene synonyms
NR1C3
NCBI Gene ID
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
Mouse ortholog
Pparg (19016)
peroxisome proliferator-activated receptor gamma (P37238)
Alternate
Variants
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Financial
Revenue by drug
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Estimated US medical usage
Pioglitazone
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Glimepiride
Total medical expenditures per year (USD, in millions)
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Pioglitazone
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Metformin
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Pioglitazone
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Actoplus met, Actos, Alogliptin and pioglitazone, Duetact, Oseni, Pioglitazole and metformin hydrochloride, Pioglitazone, Pioglitazone and glimepiride, Pioglitazone and metformin, Pioglitazone and metformin hydrochloride, Pioglitazone hcl and metformin hcl, Pioglitazone hydrochloride, Pioglitazone hydrochloride and metformin hydrochloride, Pioglitazonehydrochloride
Adverse Events
Top Adverse Reactions
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22,255 adverse events reported
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