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 | 2024-08-13 |
| duetact | New Drug Application | 2025-03-27 |
| oseni | New Drug Application | 2025-02-28 |
| pioglitazone | ANDA | 2025-05-17 |
| pioglitazone and glimepiride | NDA authorized generic | 2021-12-16 |
| pioglitazone and metformin | ANDA | 2016-11-23 |
| pioglitazone hydrochloride | ANDA | 2025-05-17 |
| pioglitazone hydrochloride and metformin hydrochloride | ANDA | 2025-02-27 |
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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
551 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 | 9 | 34 | 93 | 79 | 52 | 259 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 8 | 36 | 93 | 73 | 34 | 236 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 4 | 11 | 6 | 13 | 7 | 39 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 8 | 3 | 15 | 6 | 33 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 7 | 4 | 13 | 4 | 29 |
| Healthy volunteers/patients | — | — | — | 24 | 1 | — | 1 | 1 | 27 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 3 | 5 | 2 | 6 | 6 | 21 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 6 | 2 | 1 | 4 | 6 | 19 |
| Syndrome | D013577 | — | — | 5 | 4 | 1 | 6 | 3 | 18 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | 1 | 2 | 9 | 5 | 18 |
Show 80 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 3 | 2 | 1 | — | — | 6 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 3 | 1 | — | — | 4 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | — | 1 | — | 1 | 4 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 2 | — | 1 | — | 1 | 4 |
| Dyslipidemias | D050171 | — | — | — | — | 2 | — | 1 | 3 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | 1 | 1 | — | 1 | 3 |
| Kidney transplantation | D016030 | — | — | — | 1 | 1 | — | 1 | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 2 | — | — | 3 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | 1 | 1 | 1 | — | — | 2 |
| Depression | D003863 | — | F33.9 | — | 2 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 2 | 6 | — | — | — | 7 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | 7 | — | — | — | 7 |
| Myeloid leukemia | D007951 | — | C92 | 2 | 6 | — | — | — | 7 |
| Lung neoplasms | D008175 | — | C34.90 | — | 6 | — | — | 1 | 7 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 3 | 5 | — | — | 1 | 6 |
| Sclerosis | D012598 | — | — | 3 | 3 | — | — | — | 4 |
| Hyperglycemia | D006943 | — | R73.9 | 2 | 2 | — | — | 1 | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 3 | — | — | 1 | 4 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | 3 | — | — | — | 3 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | 2 | — | — | 1 | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | 3 | — | — | — | — | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | 2 | 3 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Ketosis | D007662 | — | R82.4 | 1 | — | — | — | 1 | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 2 | — | — | — | — | 2 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | 1 | — | — | — | — | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | — | — | — | 1 |
Show 17 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes complications | D048909 | — | — | — | — | — | — | 3 | 3 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | — | 3 | 3 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | — | — | 2 | 2 |
| Body-weight trajectory | D000077962 | — | — | — | — | — | — | 1 | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 1 | 1 |
| Diabetic ketoacidosis | D016883 | EFO_1000897 | — | — | — | — | — | 1 | 1 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 1 | 1 |
| Peritoneal dialysis | D010530 | — | — | — | — | — | — | 1 | 1 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | — | — | — | — | 1 | 1 |
| Hypogonadism | D007006 | — | E23.0 | — | — | — | — | 1 | 1 |
Show 14 more
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
Total medical expenditures per year (USD, in millions)
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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, Pioglitazone, Pioglitazone and glimepiride, Pioglitazone and metformin, Pioglitazone hydrochloride, Pioglitazone hydrochloride and metformin hydrochloride, Pioglitazonehydrochloride
Adverse Events
Top Adverse Reactions
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22,303 adverse events reported
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