Alogliptin

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Alogliptin
Alogliptin.svg
Systematic (IUPAC) name
2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile
Clinical data
Trade names Nesina, Vipidia
Kazano, Vipidomet (with metformin)
Oseni, Incresync (with pioglitazone)
Pregnancy
category
  • US: B (No risk in non-human studies)
Legal status
  • ℞ (Prescription only)
Routes of
administration		 Oral
Pharmacokinetic data
Bioavailability 100%
Protein binding 20%
Metabolism Limited, hepatic (CYP2D6- and 3A4-mediated)
Biological half-life 12–21 hours
Excretion Renal (major) and fecal (minor)
Identifiers
CAS Number 850649-62-6 YesY
ATC code A10BH04 (WHO)
PubChem CID: 11450633
IUPHAR/BPS 6319
ChemSpider 9625485 YesY
UNII JHC049LO86 YesY
KEGG D06553 YesY
ChEBI CHEBI:72323 N
ChEMBL CHEMBL376359 YesY
Synonyms SYR-322
Chemical data
Formula C18H21N5O2
Molecular mass 339.39 g/mol
  • 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 YesY
  • Key:ZSBOMTDTBDDKMP-OAHLLOKOSA-N YesY
 NYesY (what is this?)  (verify)

Alogliptin (trade name Nesina in the US[1] and Vipidia in Europe[2]) is an orally administered anti-diabetic drug in the DPP-4 inhibitor class,[3] developed by Syrrx, a company which was acquired by Takeda Pharmaceutical Company in 2005.[4] Like other medications for the treatment of Type 2 diabetes, 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 causing hypoglycemia, and exhibits relatively modest glucose-lowering activity. Alogliptin and other gliptins are commonly used in combination with metformin in patients whose diabetes cannot adequately be controlled with metformin alone.[5] In April 2016, the U.S. FDA added a warning about increased risk of heart failure.[6]

Medical uses

Alogliptin is a dipeptidyl peptidase-4 inhibitor that decreases blood sugar similar to the other.[7]

Side effects

Adverse events include mild hypoglycemia based on clinical studies.[8][9][10] It may cause severe joint pain.[11]

Alogliptin is not associated with increased weight, increased risk of cardiovasular events.[12][13] In April 2016, the U.S. FDA added a warning about increased risk of heart failure.[6]

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 Adminiistration (USFDA),[14] after positive results from Phase III clinical trials.[1] In September 2008, the company also filed for approval in Japan,[15] winning approval in April 2010.[14] The company also filed a Marketing Authorization Application (MAA) elsewhere outside the United States, which was withdrawn in June 2009 needing more data.[15] 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.[14] In 2012, Takeda received a negative response from the USFDA on both of these NDAs, citing a need for additional data.[14]

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.

See also

References

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  1. ↑ 1.0 1.1 Lua error in package.lua at line 80: module 'strict' not found.
  2. ↑ Vipidia: EPAR summary for the public (European Medicines Agency)
  3. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  4. ↑ [1]
  5. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  6. ↑ 6.0 6.1 Lua error in package.lua at line 80: module 'strict' not found.
  7. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  8. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  9. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  10. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  11. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  12. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  13. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  14. ↑ 14.0 14.1 14.2 14.3 Lua error in package.lua at line 80: module 'strict' not found.
  15. ↑ 15.0 15.1 Lua error in package.lua at line 80: module 'strict' not found.
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