Clinical data | |
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Trade names | Nesina, Vipidia Kazano, Vipidomet (with metformin) Oseni, Incresync (with pioglitazone) |
Other names | SYR-322 |
AHFS/ Drugs.com | Monograph |
MedlinePlus | a613026 |
License data |
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Pregnancy category |
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Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Bioavailability | 100% |
Protein binding | 20% |
Metabolism | Limited, liver ( CYP2D6- and 3A4-mediated) |
Elimination half-life | 12–21 hours |
Excretion | Kidney (major) [1] and fecal (minor) |
Identifiers | |
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CAS Number |
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PubChem CID | |
IUPHAR/BPS | |
ChemSpider | |
UNII |
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KEGG | |
ChEBI | |
ChEMBL | |
CompTox Dashboard ( EPA) | |
ECHA InfoCard | 100.256.501 |
Chemical and physical data | |
Formula | C18H21N5O2 |
Molar mass | 339.399 g·mol−1 |
3D model ( JSmol) | |
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(what is this?) (verify) |
Alogliptin, sold under the brand names Nesina and Vipidia, [2] [3] is an oral anti-diabetic drug in the DPP-4 inhibitor (gliptin) class. [4] Like other members of the gliptin class, it causes little or no weight gain, exhibits relatively little risk of hypoglycemia, and has relatively modest glucose-lowering activity. [1] Alogliptin and other gliptins are commonly used in combination with metformin in people whose diabetes cannot adequately be controlled with metformin alone. [1]
In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure. [5] It was developed by Syrrx, a company which was acquired by Takeda Pharmaceutical Company in 2005. [6] In 2020, it was the 295th most commonly prescribed medication in the United States, with more than 1 million prescriptions. [7] [8]
Alogliptin is a dipeptidyl peptidase-4 inhibitor (DDP-4) that decreases blood sugar levels similar to other DPP-4 inhibitors. [9]
Adverse events include hypoglycemia, [10] [11] [12] pruritis (itching), [3] nasopharyngitis, headache, and upper respiratory tract infection. [13] It may also cause joint pain that can be severe and disabling. [14] Like other DDP-4 inhibitors, alogliptin is weight-neutral. [1]
A 2014 letter to the editor claimed alogliptin is not associated with increased risk of cardiovascular events. [15][ better source needed] In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure. [5]
In December 2007, Takeda submitted a New Drug Application (NDA) for alogliptin to the United States Food and Drug Administration (FDA), [16] after positive results from Phase III clinical trials. [2] In September 2008, the company also filed for approval in Japan, [17] winning approval in April 2010. [16] The company also filed a Marketing Authorization Application elsewhere outside the United States, which was withdrawn in June 2009 needing more data. [17] The first NDA failed to gain approval and was followed by a pair of NDAs (one for alogliptin and a second for a combination of alogliptin and pioglitazone) in July 2011. [16] In 2012, Takeda received a negative response from the FDA on both of these NDAs, citing a need for additional data. [16]
In 2013, the FDA approved the drug in three formulations: as a stand-alone with the brand-name Nesina, [13] combined with metformin using the name Kazano, [18] and when combined with pioglitazone as Oseni. [19]
Clinical data | |
---|---|
Trade names | Nesina, Vipidia Kazano, Vipidomet (with metformin) Oseni, Incresync (with pioglitazone) |
Other names | SYR-322 |
AHFS/ Drugs.com | Monograph |
MedlinePlus | a613026 |
License data |
|
Pregnancy category |
|
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Bioavailability | 100% |
Protein binding | 20% |
Metabolism | Limited, liver ( CYP2D6- and 3A4-mediated) |
Elimination half-life | 12–21 hours |
Excretion | Kidney (major) [1] and fecal (minor) |
Identifiers | |
| |
CAS Number |
|
PubChem CID | |
IUPHAR/BPS | |
ChemSpider | |
UNII |
|
KEGG | |
ChEBI | |
ChEMBL | |
CompTox Dashboard ( EPA) | |
ECHA InfoCard | 100.256.501 |
Chemical and physical data | |
Formula | C18H21N5O2 |
Molar mass | 339.399 g·mol−1 |
3D model ( JSmol) | |
| |
| |
(what is this?) (verify) |
Alogliptin, sold under the brand names Nesina and Vipidia, [2] [3] is an oral anti-diabetic drug in the DPP-4 inhibitor (gliptin) class. [4] Like other members of the gliptin class, it causes little or no weight gain, exhibits relatively little risk of hypoglycemia, and has relatively modest glucose-lowering activity. [1] Alogliptin and other gliptins are commonly used in combination with metformin in people whose diabetes cannot adequately be controlled with metformin alone. [1]
In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure. [5] It was developed by Syrrx, a company which was acquired by Takeda Pharmaceutical Company in 2005. [6] In 2020, it was the 295th most commonly prescribed medication in the United States, with more than 1 million prescriptions. [7] [8]
Alogliptin is a dipeptidyl peptidase-4 inhibitor (DDP-4) that decreases blood sugar levels similar to other DPP-4 inhibitors. [9]
Adverse events include hypoglycemia, [10] [11] [12] pruritis (itching), [3] nasopharyngitis, headache, and upper respiratory tract infection. [13] It may also cause joint pain that can be severe and disabling. [14] Like other DDP-4 inhibitors, alogliptin is weight-neutral. [1]
A 2014 letter to the editor claimed alogliptin is not associated with increased risk of cardiovascular events. [15][ better source needed] In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure. [5]
In December 2007, Takeda submitted a New Drug Application (NDA) for alogliptin to the United States Food and Drug Administration (FDA), [16] after positive results from Phase III clinical trials. [2] In September 2008, the company also filed for approval in Japan, [17] winning approval in April 2010. [16] The company also filed a Marketing Authorization Application elsewhere outside the United States, which was withdrawn in June 2009 needing more data. [17] The first NDA failed to gain approval and was followed by a pair of NDAs (one for alogliptin and a second for a combination of alogliptin and pioglitazone) in July 2011. [16] In 2012, Takeda received a negative response from the FDA on both of these NDAs, citing a need for additional data. [16]
In 2013, the FDA approved the drug in three formulations: as a stand-alone with the brand-name Nesina, [13] combined with metformin using the name Kazano, [18] and when combined with pioglitazone as Oseni. [19]