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Takeda Pharmaceutical Company
Alogliptin
Другие языки:

Alogliptin

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Alogliptin
Alogliptin.svg
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
  • AU: B3
Routes of
administration		 By mouth
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability 100%
Protein binding 20%
Metabolism Limited, liver (CYP2D6- and 3A4-mediated)
Elimination half-life 12–21 hours
Excretion Kidney (major) and fecal (minor)
Identifiers
  • 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile
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)
  • N#Cc3ccccc3CN\1C(=O)N(C)C(=O)/C=C/1N2CCC[C@@H](N)C2
  • InChI=1S/C18H21N5O2/c1-21-17(24)9-16(22-8-4-7-15(20)12-22)23(18(21)25)11-14-6-3-2-5-13(14)10-19/h2-3,5-6,9,15H,4,7-8,11-12,20H2,1H3/t15-/m1/s1 checkY
  • Key:ZSBOMTDTBDDKMP-OAHLLOKOSA-N checkY
 ☒NcheckY (what is this?)  (verify)

Alogliptin, sold under the brand names Nesina and Vipidia,) is an oral anti-diabetic drug in the DPP-4 inhibitor (gliptin) class. Alogliptin does not decrease the risk of heart attack and stroke. 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. Alogliptin and other gliptins are commonly used in combination with metformin in people whose diabetes cannot adequately be controlled with metformin alone.

In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure. It was developed by Syrrx, a company which was acquired by Takeda Pharmaceutical Company in 2005. In 2020, it was the 295th most commonly prescribed medication in the United States, with more than 1 million prescriptions.

Medical uses

Alogliptin is a dipeptidyl peptidase-4 inhibitor that decreases blood sugar similar to the other.

Side effects

Adverse events include mild hypoglycemia based on clinical studies. Alogliptin is not associated with increased weight, increased risk of cardiovascular events. It may also cause joint pain that can be severe and disabling. In April 2016, the U.S. Food and Drug Administration (FDA) added a warning about increased risk of heart failure.

Market access

Alogliptin tablets sales in Mainland China. Specification is 25mg * 10 tablets.

In December 2007, Takeda submitted a New Drug Application (NDA) for alogliptin to the United States Food and Drug Administration (USFDA), after positive results from Phase III clinical trials. In September 2008, the company also filed for approval in Japan, winning approval in April 2010. The company also filed a Marketing Authorization Application (MAA) elsewhere outside the United States, which was withdrawn in June 2009 needing more data. The first USFDA 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. In 2012, Takeda received a negative response from the USFDA on both of these NDAs, citing a need for additional data.

In 2013, the FDA approved the drug in three formulations: as a stand-alone with the brand-name Nesina, combined with metformin using the name Kazano, and when combined with pioglitazone as Oseni.

External links

  • Media related to Alogliptin at Wikimedia Commons
  • "Alogliptin". Drug Information Portal. U.S. National Library of Medicine.

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