Actos, Glustin(pioglitazone)
Actoplus Met, Actos, Competact, Duetact, Incresync, Oseni, 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
Trade Name
FDA
EMA
Actos (generic drugs available since 2012-10-26)
CombinationsActoplus met, Duetact, Oseni (generic drugs available since 2012-10-26)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Alogliptin benzoate
+
Pioglitazone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OSENI | Takeda | N-022426 RX | 2013-01-25 | 4 products, RLD |
Show 1 discontinued
Glimepiride
+
Pioglitazone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUETACT | Takeda | N-021925 RX | 2006-07-28 | 2 products, RLD |
Metformin hydrochloride
+
Pioglitazone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACTOPLUS MET | Takeda | N-021842 RX | 2005-08-29 | 1 products, RLD, RS |
Show 2 discontinued
Pioglitazone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACTOS | Takeda | N-021073 RX | 1999-07-15 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| actoplus met | New Drug Application | 2021-01-13 |
| actos | New Drug Application | 2021-01-13 |
| duetact | New Drug Application | 2021-01-13 |
| oseni | New Drug Application | 2021-04-30 |
| pioglitazone | ANDA | 2023-06-20 |
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
457 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 | 7 | 31 | 59 | 58 | 33 | 181 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 7 | 15 | 11 | 1 | 34 |
| Insulin resistance | D007333 | EFO_0002614 | 2 | 8 | 5 | 10 | 5 | 28 | |
| Healthy volunteers/patients | — | 24 | 1 | — | 1 | 1 | 27 | ||
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 4 | 1 | 10 | — | 16 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 1 | 3 | 1 | 6 | 4 | 15 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 3 | 2 | — | 3 | 6 | 14 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 4 | 1 | — | 4 | 2 | 11 |
| Coronary artery disease | D003324 | I25.1 | — | 2 | 2 | 4 | — | 7 | |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 2 | 1 | 2 | 2 | 7 |
Show 41 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 3 | 1 | — | — | 4 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | — | 1 | — | 1 | 4 |
| Prostatic neoplasms | D011471 | C61 | 1 | 2 | 1 | — | — | 4 | |
| 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 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | 1 | — | 1 | 2 | |
| Risk reduction behavior | D040242 | — | — | 1 | — | — | 1 | ||
| Coronary restenosis | D023903 | EFO_0004224 | — | — | 1 | — | — | 1 | |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | 1 | — | — | 1 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 5 | — | — | — | 5 | |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 3 | 5 | — | — | — | 5 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 4 | — | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | 3 | — | — | — | 3 | ||
| Oral leukoplakia | D007972 | K13.21 | — | 3 | — | — | — | 3 | |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | 1 | — | — | — | 2 |
| Squamous cell carcinoma | D002294 | — | 2 | — | — | — | 2 | ||
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | 2 | — | — | — | 2 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 1 | 2 | — | — | — | 2 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | 1 | 1 | — | — | 1 | 2 |
Show 36 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | 2 | 3 |
| Infertility | D007246 | EFO_0000545 | 2 | — | — | — | — | 2 | |
| Castration-resistant prostatic neoplasms | D064129 | 2 | — | — | — | — | 2 | ||
| Peripheral arterial disease | D058729 | EFO_0004265 | 1 | — | — | — | — | 1 | |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | — | — | — | — | 1 |
| Overweight | D050177 | E66.3 | 1 | — | — | — | — | 1 | |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 2 | 2 | |
| Urinary bladder neoplasms | D001749 | C67 | — | — | — | — | 2 | 2 | |
| Ketosis | D007662 | HP_0002919 | R82.4 | — | — | — | — | 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 | |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | — | — | — | 1 | 1 |
Show 4 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 |
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Actoplus met, Actos, Duetact, Oseni, Pioglitazone
Adverse Events
Top Adverse Reactions
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10,353 adverse events reported
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