Alogliptin

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Alogliptin
Alogliptin.svg
Names
Trade namesNesina, Vipidia
Kazano, Vipidomet (with metformin)
Oseni, Incresync (with pioglitazone)
Other namesAlogliptin benzoate, SYR-322
  • 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile
Clinical data
Drug classDPP-4 inhibitor (gliptin)[1]
Main usesType 2 diabetes[1]
Side effectsRunny nose, headache, upper respiratory tract infection[1]
Pregnancy
category
  • AU: B3
  • US: B (No risk in non-human studies)
Routes of
use
By mouth
Typical dose25 mg OD[2]
External links
AHFS/Drugs.comMonograph
US NLMAlogliptin
MedlinePlusa613026
Legal
License data
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Pharmacokinetics
Bioavailability100%
Protein binding20%
MetabolismLimited, liver (CYP2D6- and 3A4-mediated)
Elimination half-life12–21 hours
ExcretionKidney (major) and fecal (minor)
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

Alogliptin, sold under the brand names Nesina and Vipidia among others, is a medication used to treat type 2 diabetes.[1] It is a second line treatment used together with diet and exercise.[3] Effects on the risk of heart disease are unclear.[1] It is taken by mouth.[2]

Common side effects include runny nose, headache, and upper respiratory tract infection.[1] Other side effects may include pancreatitis, heart failure, anaphylaxis, liver problems, and low blood sugar.[1] Safety in pregnancy is unclear.[1] It is a DPP-4 inhibitor (gliptin), which works by increasing insulin secretion from the pancreas.[1][2]

Alogliptin was approved for medical use in the United States and Europe in 2013.[1][4] In the United Kingdom 4 weeks costs the NHS about £27 as of 2021.[2] This amount in the United States is about 90 USD.[5] It is also available as a combination medication with metformin or pioglitazone.[3]

Medical uses

Alogliptin is a dipeptidyl peptidase-4 inhibitor that decreases blood sugar similar to the other.[6]

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.[7]

Dosage

It is taken at a dose of 25 mg once per day.[2]

Side effects

Side effects may 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. Food and Drug Administration (FDA) added a warning about increased risk of heart failure.[14]

History

It was developed by Syrrx, a company which was acquired by Takeda Pharmaceutical Company in 2005.[15]

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),[16] after positive results from Phase III clinical trials.[17] In September 2008, the company also filed for approval in Japan,[18] winning approval in April 2010.[16] The company also filed a Marketing Authorization Application (MAA) elsewhere outside the United States, which was withdrawn in June 2009 needing more data.[18] 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.[16] In 2012, Takeda received a negative response from the USFDA 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, combined with metformin using the name Kazano, and when combined with pioglitazone as Oseni.

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 "DailyMed - ALOGLIPTIN tablet, film coated". dailymed.nlm.nih.gov. Archived from the original on 10 November 2021. Retrieved 14 January 2022.
  2. 2.0 2.1 2.2 2.3 2.4 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 734. ISBN 978-0857114105.
  3. 3.0 3.1 "Alogliptin Monograph for Professionals". Drugs.com. Archived from the original on 28 January 2021. Retrieved 14 January 2022.
  4. "Vipidia". Archived from the original on 16 November 2021. Retrieved 14 January 2022.
  5. "Alogliptin Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 14 January 2022.
  6. 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.
  7. "www.aace.com" (PDF). Archived from the original (PDF) on 2018-11-01.
  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, S2CID 24082863
  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, S2CID 45948727
  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, S2CID 1092260
  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. hdl:10447/94479. PMID 23992602. Archived (PDF) from the original on 2021-11-05. Retrieved 2021-05-07.
  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". U.S. Food and Drug Administration (FDA). 2015-08-28. Archived from the original on 2019-12-13. Retrieved 1 September 2015.
  14. "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). Archived from the original on 11 August 2020. Retrieved 16 March 2018.
  15. "Archive copy". Archived from the original on 2014-03-08. Retrieved 2021-05-07.{{cite web}}: CS1 maint: archived copy as title (link)
  16. 16.0 16.1 16.2 16.3 Grogan, Kevin (April 26, 2012), "FDA wants yet more data on Takeda diabetes drug alogliptin", PharmaTimes, PharmaTimes, PharmaTimes online, archived from the original on September 24, 2015, retrieved April 26, 2012
  17. "Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S." (Press release). Takeda Pharmaceutical Company. January 3, 2008. Archived from the original on December 3, 2020. Retrieved March 11, 2021.
  18. 18.0 18.1 "GEN News Highlights: Takeda Pulls MAA for Type 2 Diabetes Therapy". Genetic Engineering & Biotechnology News. June 4, 2009.

External links

Identifiers:
  • "Alogliptin". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-11-05. Retrieved 2021-05-07.