Alogliptin

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Alogliptin
Alogliptin.svg
Clinical data
Trade namesNesina, Vipidia
Kazano, Vipidomet (with metformin)
Oseni, Incresync (with pioglitazone)
Other namesSYR-322
License data
Pregnancy
category
  • US: B (No risk in non-human studies)
Routes of
administration
Oral
ATC code
Legal status
Legal status
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability100%
Protein binding20%
MetabolismLimited, hepatic (CYP2D6- and 3A4-mediated)
Elimination half-life12–21 hours
ExcretionRenal (major) and fecal (minor)
Identifiers
CAS Number
PubChem CID
IUPHAR/BPS
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.256.501 Edit this at Wikidata
Chemical and physical data
FormulaC18H21N5O2
Molar mass339.39 g/mol g·mol−1
3D model (JSmol)
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Alogliptin (trade name Nesina and Vipidia[1][2]) is an oral anti-diabetic drug in the DPP-4 inhibitor (gliptin) class.[3] 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.[4]

In April 2016, the U.S. 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]

Medical uses[edit]

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

Side effects[edit]

Adverse events include mild hypoglycemia based on clinical studies.[8][9][10] Alogliptin is not associated with increased weight, increased risk of cardiovascular events.[11][12] It may also cause joint pain that can be severe and disabling.[13] In April 2016, the U.S. FDA added a warning about increased risk of heart failure.[5]

Market access[edit]

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),[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[edit]

References[edit]

  1. ^ a b "Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S." (Press release). Takeda Pharmaceutical Company. January 4, 2008. Retrieved January 9, 2008.
  2. ^ Vipidia: EPAR summary for the public (European Medicines Agency)
  3. ^ Feng, Jun; Zhang, Zhiyuan; Wallace, Michael B.; Stafford, Jeffrey A.; Kaldor, Stephen W.; Kassell, Daniel B.; Navre, Marc; Shi, Lihong; Skene, Robert J.; Asakawa, Tomoko; Takeuchi, Koji; Xu, Rongda; Webb, David R.; Gwaltney II, Stephen L. (2007). "Discovery of alogliptin: a potent, selective, bioavailable, and efficacious inhibitor of dipeptidyl peptidase IV". J. Med. Chem. 50 (10): 2297–2300. doi:10.1021/jm070104l. PMID 17441705.
  4. ^ "www.aace.com" (PDF).
  5. ^ a b "FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin". www.fda.gov. Retrieved 16 March 2018.
  6. ^ [1]
  7. ^ Saisho, Y (2015). "Alogliptin benzoate for management of type 2 diabetes". Vascular Health and Risk Management. 11: 229–43. doi:10.2147/VHRM.S68564. PMC 4401208. PMID 25914541.
  8. ^ Seino, Yutaka; Fujita, Tetsuya; Hiroi, Shinzo; Hirayama, Masashi; Kaku, Kohei (September 2011), "Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study (abstract only)", Current Medical Research and Opinion, 27 (9): 1781–1792, doi:10.1185/03007995.2011.599371, PMID 21806314
  9. ^ Kutoh, Eiji; Ukai, Yasuhiro (2012), "Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial (abstract only)", Endocrine (published January 17, 2012), 41 (3): 435–41, doi:10.1007/s12020-012-9596-0, PMID 22249941, retrieved April 26, 2012
  10. ^ Bosi, Emanuele; Ellis, G.C.; Wilson, C.A.; Fleck, P.R. (October 2011), "Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, double-blind, active-controlled, parallel-group study", Diabetes, Obesity and Metabolism (published October 27, 2011), 13 (12): 1088–1096, doi:10.1111/j.1463-1326.2011.01463.x, PMID 21733058
  11. ^ White WB, Cannon CP, Heller SR, et al. (October 2013). "Alogliptin after acute coronary syndrome in patients with type 2 diabetes" (PDF). N. Engl. J. Med. 369 (14): 1327–35. doi:10.1056/NEJMoa1305889. PMID 23992602.
  12. ^ White WB, Zannad F (January 2014). "Saxagliptin, alogliptin, and cardiovascular outcomes". N. Engl. J. Med. 370 (5): 483–484. doi:10.1056/NEJMc1313880. PMID 24482824.
  13. ^ "DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain". FDA. 2015-08-28. Retrieved 1 September 2015.
  14. ^ a b c d Grogan, Kevin (April 26, 2012), "FDA wants yet more data on Takeda diabetes drug alogliptin", PharmaTimes, PharmaTimes, PharmaTimes online, retrieved April 26, 2012
  15. ^ a b "GEN News Highlights: Takeda Pulls MAA for Type 2 Diabetes Therapy". Genetic Engineering & Biotechnology News. June 4, 2009.