Jump to content
 







Main menu
   


Navigation  



Main page
Contents
Current events
Random article
About Wikipedia
Contact us
Donate
 




Contribute  



Help
Learn to edit
Community portal
Recent changes
Upload file
 








Search  

































Create account

Log in
 









Create account
 Log in
 




Pages for logged out editors learn more  



Contributions
Talk
 



















Contents

   



(Top)
 


1 Medical uses  





2 Side effects  





3 Market access  





4 References  





5 External links  














Alogliptin






العربية
Deutsch
Ελληνικά
Español
فارسی
Français
Italiano

ି
Српски / srpski
Srpskohrvatski / српскохрватски

 

Edit links
 









Article
Talk
 

















Read
Edit
View history
 








Tools
   


Actions  



Read
Edit
View history
 




General  



What links here
Related changes
Upload file
Special pages
Permanent link
Page information
Cite this page
Get shortened URL
Download QR code
Wikidata item
 




Print/export  



Download as PDF
Printable version
 




In other projects  



Wikimedia Commons
 
















Appearance
   

 






From Wikipedia, the free encyclopedia
 


Alogliptin
Clinical data
Trade namesNesina, Vipidia
Kazano, Vipidomet (with metformin)
Oseni, Incresync (with pioglitazone)
Other namesSYR-322
AHFS/Drugs.comMonograph
MedlinePlusa613026
License data
  • US DailyMedAlogliptin
  • 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
    Bioavailability100%
    Protein binding20%
    MetabolismLimited, liver (CYP2D6- and 3A4-mediated)
    Elimination half-life12–21 hours
    ExcretionKidney (major)[1] 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
  • benzoate: 850649-62-6 checkY
  • PubChem CID
    IUPHAR/BPS
    ChemSpider
    UNII
  • benzoate: EEN99869SC checkY
  • KEGG
    ChEBI
    ChEMBL
    CompTox Dashboard (EPA)
    ECHA InfoCard100.256.501 Edit this at Wikidata
    Chemical and physical data
    FormulaC18H21N5O2
    Molar mass339.399 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,[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]

    Medical uses[edit]

    Alogliptin is a dipeptidyl peptidase-4 inhibitor (DDP-4) that decreases blood sugar levels similar to other DPP-4 inhibitors.[9]

    Side effects[edit]

    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]

    Market access[edit]

    Alogliptin tablets sales in mainland China. Specification is 25 mg × 10 tablets.

    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]

    References[edit]

    1. ^ a b c d "www.aace.com" (PDF). Archived from the original (PDF) on 2018-11-01.
  • ^ a b "Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S." (Press release). Takeda Pharmaceutical Company. January 3, 2008. Retrieved March 11, 2021.
  • ^ a b "Vipidia" (PDF). European Medicines Agency. Archived from the original (PDF) on 1 November 2018. Retrieved 31 March 2024.
  • ^ Feng J, Zhang Z, Wallace MB, Stafford JA, Kaldor SW, Kassel DB, et al. (May 2007). "Discovery of alogliptin: a potent, selective, bioavailable, and efficacious inhibitor of dipeptidyl peptidase IV". Journal of Medicinal Chemistry. 50 (10): 2297–2300. doi:10.1021/jm070104l. PMID 17441705.
  • ^ a b "FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin". U.S. Food and Drug Administration (FDA). Retrieved 16 March 2018.
  • ^ "The San Diego Union-Tribune - San Diego, California & National News".
  • ^ "The Top 300 of 2020". ClinCalc. Retrieved 7 October 2022.
  • ^ "Alogliptin - Drug Usage Statistics". ClinCalc. Retrieved 7 October 2022.
  • ^ Saisho Y (2015). "Alogliptin benzoate for management of type 2 diabetes". Vascular Health and Risk Management. 11: 229–243. doi:10.2147/VHRM.S68564. PMC 4401208. PMID 25914541.
  • ^ Seino Y, Fujita T, Hiroi S, Hirayama M, Kaku K (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". Current Medical Research and Opinion. 27 (9): 1781–1792. doi:10.1185/03007995.2011.599371. PMID 21806314. S2CID 24082863.
  • ^ Kutoh E, Ukai Y (June 2012). "Alogliptin as an initial therapy in patients with newly diagnosed, drug naïve type 2 diabetes: a randomized, control trial". Endocrine. 41 (3) (published January 17, 2012): 435–441. doi:10.1007/s12020-012-9596-0. PMID 22249941. S2CID 45948727.
  • ^ Bosi E, Ellis GC, Wilson CA, Fleck PR (December 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 & Metabolism. 13 (12) (published October 27, 2011): 1088–1096. doi:10.1111/j.1463-1326.2011.01463.x. PMID 21733058. S2CID 1092260.
  • ^ a b "Highlights of Prescribing Information: Nesina" (PDF). US Food and Drug Administration. Retrieved 31 March 2024.
  • ^ "DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain". U.S. Food and Drug Administration (FDA). 2015-08-28. Retrieved 1 September 2015.
  • ^ White WB, Zannad F (January 2014). "Saxagliptin, alogliptin, and cardiovascular outcomes". The New England Journal of Medicine. 370 (5): 484. doi:10.1056/NEJMc1313880. PMID 24482824.
  • ^ a b c d Grogan K (April 26, 2012), "FDA wants yet more data on Takeda diabetes drug alogliptin", PharmaTimes, PharmaTimes, PharmaTimes online, retrieved April 26, 2012
  • ^ a b "GEN News Highlights: Takeda Pulls MAA for Type 2 Diabetes Therapy". Genetic Engineering & Biotechnology News. June 4, 2009.
  • ^ "Highlights of Prescribing Information: Kazano" (PDF). US Food and Drug Administration. Retrieved 31 March 2024.
  • ^ "Highlights of Prescribing Information: Oseni" (PDF). US Food and Drug Administration. Retrieved 31 March 2024.
  • External links[edit]


    Retrieved from "https://en.wikipedia.org/w/index.php?title=Alogliptin&oldid=1216586333"

    Categories: 
    Dipeptidyl peptidase-4 inhibitors
    Nitriles
    Piperidines
    Ureas
    Imides
    Pyrimidinediones
    Enantiopure drugs
    Drugs developed by Takeda Pharmaceutical Company
    Sanofi
    Hidden categories: 
    Articles with short description
    Short description is different from Wikidata
    Drugs with non-standard legal status
    Articles with changed EBI identifier
    ECHA InfoCard ID from Wikidata
    Chemical pages without DrugBank identifier
    Multiple chemicals in Infobox drug
    Chemicals using indexlabels
    Chemical articles with multiple CAS registry numbers
    Drug has EMA link
    Drugboxes which contain changes to verified fields
    Drugboxes which contain changes to watched fields
    All articles lacking reliable references
    Articles lacking reliable references from March 2024
    Commons category link from Wikidata
     



    This page was last edited on 31 March 2024, at 22:13 (UTC).

    Text is available under the Creative Commons Attribution-ShareAlike License 4.0; additional terms may apply. By using this site, you agree to the Terms of Use and Privacy Policy. Wikipedia® is a registered trademark of the Wikimedia Foundation, Inc., a non-profit organization.



    Privacy policy

    About Wikipedia

    Disclaimers

    Contact Wikipedia

    Code of Conduct

    Developers

    Statistics

    Cookie statement

    Mobile view



    Wikimedia Foundation
    Powered by MediaWiki