Drugs / Alogliptin
Alogliptin
also known as
alogliptin benzoate · SYR-322 · Alogliptin (SYR-322) · Alogliptin and Metformin Fixed-Dose Combination (FDC) · Nesina
targets DPP4 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vipdomet | — | 2013-09-18 | europa.eu ↗ |
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 missed | ||||||
| Phase 1 | NCT05364164 | Jul 2022 | — | Celltrion | Completed | No outcome recorded |
| Phase 1 | NCT02508168 | Apr 2016 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01664624 | Jul → Nov 2012 | type 2 diabetes mellitus | AstraZeneca | Completed | Missed primary |
| Phase 1 | NCT01391663 | Jul → Sep 2011 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT00957268 | Sep 2009 → Nov 2013 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 23 trials · 2 met primary | ||||||
| Phase 2 | NCT01263496 | May 2007 → Sep 2008 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01263470 | Jan → Dec 2007 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 2 | NCT00755846 | Mar → Oct 2005 | diabetes mellitus | Takeda | Completed | Met primary |
| Phase 2/33 trials · 2 met primary | ||||||
| Phase 2/3 | NCT01318070 | Nov 2007 → Oct 2008 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 2/3 | NCT01263509 | Jun 2007 → Oct 2008 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 2/3 | NCT01263483 | Jan 2007 → Apr 2008 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 319 trials · 14 met primary · 1 missed | ||||||
| Phase 3 | NCT02856113 | Oct 2016 → Aug 2021 | type 2 diabetes mellitus | Takeda | Completed | Missed primary |
| Phase 3 | NCT01890122 | Sep 2013 → Sep 2015 | diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT01521962 | Feb 2012 → Mar 2013 | diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT01456130 | Nov 2011 → Mar 2013 | diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT01289119 | Dec 2010 → Dec 2011 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT01023581 | Nov 2009 → Jun 2011 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00968708 | Sep 2009 → Apr 2013 | acute coronary syndrome, type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00856284 | Mar 2009 → Oct 2012 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00707993 | Jun 2008 → Aug 2010 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00655863 | Jul 2007 → Dec 2009 | diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00432276 | Jan 2007 → May 2009 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00395512 | Nov 2006 → Feb 2008 | diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00328627 | May 2006 → Mar 2008 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00286468 | Apr 2006 → Jun 2007 | diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00286442 | Mar 2006 → Jun 2007 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00306384 | Mar 2006 → Nov 2011 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00286429 | Feb 2006 → May 2007 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00286455 | Feb 2006 → Jul 2007 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT00286494 | Feb 2006 → Aug 2007 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 49 trials · 1 met primary | ||||||
| Phase 4 | NCT07289750 | May 2026 → Aug 2027 expected | metabolic dysfunction-associated steatotic liver disease, type 2 diabetes mellitus | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03950505 | May → Dec 2020 | metabolic dysfunction-associated steatohepatitis, type 2 diabetes mellitus | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT03794336 | Jun 2019 → Dec 2020 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT03231709 | Aug 2017 → Feb 2018 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 4 | NCT03042325 | Jul 2017 → Jan 2018 | type 2 diabetes mellitus | Takeda | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT02823808 | Jul 2017 → Jul 2021 | diabetes mellitus | Kyunghee University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02771093 | Sep 2016 → Apr 2017 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02763007 | May 2016 → Dec 2018 | type 2 diabetes mellitus | Kun-Ho Yoon | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02312427 | Jan 2015 → Mar 2016 | congestive heart failure, diabetes mellitus | Mitsui Memorial Hospital | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02798172 | May 2014 → Aug 2015 | type 2 diabetes mellitus | Fourth People's Hospital of Shenyang | Completed | No outcome recorded |
| — | NCT01303055 | Feb 2011 → Dec 2013 | type 2 diabetes mellitus | Aichi Gakuin University | Unknown | No outcome recorded |
| Comparator or background therapy18 trials | ||||||
| Phase 2 | NCT00763347 Comparator | Nov 2006 → Feb 2007 | type 2 diabetes mellitus | Takeda | Terminated | No outcome recorded |
| Phase 2/3 | NCT01318135 Comparator | Jan 2009 → Jan 2010 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 2/3 | NCT01318083 Comparator | Aug 2008 → Apr 2009 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 2/3 | NCT01318109 Comparator | Aug 2008 → Apr 2009 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 2/3 | NCT01318122 Comparator | May 2008 → Aug 2009 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT07093476 Comparator | Jul 2025 → Dec 2026 expected | type 2 diabetes mellitus | Celltrion | Recruiting | No outcome recorded |
| Phase 3 | NCT05782192 Comparator | Jun 2019 → Mar 2022 | type 2 diabetes mellitus | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT02068443 Background | Feb 2014 → Feb 2015 | type 2 diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT01632007 Comparator | May 2012 → Jul 2013 | diabetes mellitus | Takeda | Completed | Met primary |
| Phase 3 | NCT01242228 Background | Oct 2010 → Jun 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT06449235 Comparator | Sep 2024 → Apr 2025 overdue | type 2 diabetes mellitus | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04392557 Comparator | Jul → Sep 2020 | type 2 diabetes mellitus | University of Catanzaro | Unknown | No outcome recorded |
| Phase 4 | NCT03499704 Comparator | Feb 2020 → Jan 2024 | type 2 diabetes mellitus | Celltrion Pharm, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT03014479 Comparator | Feb → Oct 2017 | type 2 diabetes mellitus | Takeda | Completed | Missed primary |
| Phase 4 | NCT04470310 Comparator | Dec 2015 → May 2019 | type 2 diabetes mellitus | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02528019 Comparator | Aug 2015 → Aug 2017 | — | Kurume University | Unknown | No outcome recorded |
| Phase 4 | NCT02683226 Background | Mar → Jun 2015 | polycystic ovary syndrome | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 4 | NCT02231021 Comparator | Sep 2014 → Oct 2018 | type 2 diabetes mellitus | Kun-Ho Yoon | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2016-09-28 | Takeda | Regulatory Takeda Obtains New Drug Application Approval for Inisync ® Combination Tablets for the Treatment of Type 2 Diabetes in Japan takeda.com ↗ |
| 2016-06-12 | Takeda | Results EXAMINE Trial Post-Hoc Analyses of Mortality Data Regarding Cardiovascular Safety of Alogliptin Presented at American Diabetes Association's 76 th Scientific Sessions and Published in Diabetes Care takeda.com ↗
These data reported that alogliptin does not increase CV risk in Type 2 diabetes patients at high-risk for MACE due to a recent ACS. |
| 2016-06-06 | Takeda | Results Takeda to Present New Data at the American Diabetes Association's 76th Scientific Sessions takeda.com ↗
These data, demonstrate that alogliptin does not increase CV risk in Type 2 diabetes patients at high-risk for MACE due to a recent ACS. |
| 2015-09-28 | Takeda | Regulatory Takeda Submits a New Drug Application for the Fixed-Dose Combination of Nesina ® and Metformin Hydrochloride for the Treatment of Type 2 Diabetes in Japan takeda.com ↗ |
| 2015-06-08 | Takeda | Results Takeda Presents Additional Data from Alogliptin's EXAMINE Cardiovascular Safety Outcomes Trial at the American Diabetes Association's 75th Scientific Sessions takeda.com ↗
The data also suggested that there were no significant differences for rates of CV death or hospitalized heart failure (HHF) on alogliptin compared to placebo in ACE inhibitor treated patients. |
| 2015-04-15 | Takeda | Regulatory FDA Advisory Committee Reviews Takeda's Alogliptin EXAMINE Cardiovascular Safety Outcomes Trial takeda.com ↗
The Committee voted that, based on the data presented, the results of EXAMINE demonstrate that the use of alogliptin in patients with Type 2 diabetes has an acceptable CV risk profile. |
| 2015-03-10 | Takeda | Results Takeda Announces Publication in The Lancet of a Post Hoc Analysis of Data from the EXAMINE Cardiovascular Safety Outcomes Trial takeda.com ↗
An analysis of data from the study showed that in patients with Type 2 diabetes and recent acute coronary syndrome (ACS), dipeptidyl peptidase 4 ( DPP - 4 ) inhibitor alogliptin compared to placebo did not increase the risk of heart failure (HF) outcomes. |
| 2014-05-23 | Takeda | Regulatory Takeda Announces the Approval of Changes to the NESINA ® Indication in Japan takeda.com ↗
Takeda Pharmaceutical Company Limited (“Takeda”) announced today that the Japanese Ministry of Health, Labour and Welfare has approved an application for changes to the Nesina ® indication, a treatment for type 2 Diabetes. |
| 2014-03-28 | Takeda | Results Takeda Presents Additional Data from the EXAMINE Cardiovascular Safety Outcomes Trial at the American College of Cardiology's 63 rd Annual Scientific Session takeda.com ↗
There was also no increase in sudden cardiac death with alogliptin (n=59, 2.2%) versus placebo (n=73, 2.7%) [HR=0.80, 95% CI: 0.57, 1.12]. |
All press releases naming this drug 10 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alogliptin | “DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) will be suspended for one month and serum BNP will be measured.” NCT02312427 ↗58“Chemical Names: Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Alogliptin Class: Dipeptidyl Peptidase-4 (DPP-4) Inhibitors” NCT06449235 ↗ “Alogliptin Benzoate 12.5 mg/Metformin HCl XR 1,000 mg, FDC Tablet, dosing under fasting condition” NCT05364164 ↗ “Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin” NCT03014479 ↗ “Group who takes Alogliptin 25mg+Pioglitazone 15mg, once daily.” NCT02823808 ↗ “alogliptin (12.5-25mg daily)” NCT02528019 ↗ “metformin and alogliptin” NCT02683226 ↗ |
| Known as | Alogliptin (SYR-322) | “Alogliptin (SYR-322)” NCT01318070 ↗ |
| Known as | Alogliptin and Metformin Fixed-Dose Combination (FDC) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01890122 ↗ |
| Known as | alogliptin benzoate | “After 24 weeks of Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment, the improvement of parameters estimated by MRI and liver fibroscan will...” NCT03950505 ↗2“Alogliptin (alogliptin benzoate) is the most recent DPP-4 inhibitor; it entered the market in 2006.” NCT02798172 ↗ “Alogliptin's nonproprietary name is alogliptin benzoate and is an oval-shaped yellow tablet.” NCT04470310 ↗ |
| Known as | Nesina | “Alogliptin was provided by Takeda Chemical industries Ltd in Japan, trade name: Nesina, 25 mg/tablet.” NCT02798172 ↗ |
| Known as | SYR-322 | “Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus.” NCT01263470 ↗1“Takeda is developing alogliptin (SYR-322) for patients with type 2 diabetes mellitus.” NCT00286429 ↗ |
| Action | Inhibit | “Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme.” NCT00286429 ↗ |
| Route | Oral | “Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.” NCT00286429 ↗ |
| Target | DPP4 | “Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme.” NCT00286429 ↗ |