Clinical Trials

Numerous clinical trials evaluate the efficacy, safety, and pharmacokinetic profiles of alogliptin across Phase 1 through Phase 4 development, including pediatric and bioequivalence studies. These trials encompass completed, active recruiting, terminated, and withdrawn statuses, focusing primarily on type 2 diabetes mellitus alongside related conditions such as non-alcoholic steatohepatitis, insulin resistance, polycystic ovary syndrome, and healthy volunteer pharmacodynamics. Key sponsors include pharmaceutical companies such as Takeda and AstraZeneca, as well as clinical centers like Seoul National University Hospital and Yonsei University.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07289750 NOT_YET_RECRUITING
T2DM; MAFLD
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
 2026-05-01 PHASE4
NCT07093476 RECRUITING
T2DM; Diabete Type 2; DM
Celltrion
 2025-07-18 PHASE3
NCT03499704 COMPLETED
Diabetes Mellitus, Type 2
Celltrion Pharm, Inc.
 2020-02-11 PHASE4
NCT05363592 COMPLETED
Healthy
Celltrion
 2022-06-25 PHASE1
NCT05363384 COMPLETED
Healthy
Celltrion
 2022-06-11 PHASE1
NCT05782192 COMPLETED
Diabetes Mellitus, Type 2
Shenzhen Salubris Pharmaceuticals Co., Ltd.
 2019-06-13 PHASE3
NCT02856113 COMPLETED
Diabetes Mellitus, Type 2
Takeda
 2016-10-14 PHASE3
NCT02823808 UNKNOWN
Diabetes
Kyunghee University Medical Center
 2017-07 PHASE4
NCT03794336 COMPLETED
Type 2 Diabetes Mellitus
Sanofi
 2019-06-29 PHASE4
NCT03950505 UNKNOWN
Non-alcoholic Steatohepatitis; Type2 Diabetes
Yonsei University
 2020-05-29 PHASE4
NCT04392557 UNKNOWN
Diabetes Mellitus, Type 2
University of Catanzaro
 2020-07-01 PHASE4
NCT04470310 UNKNOWN
Type 2 Diabetes Mellitus
Seoul National University Hospital
 2015-12-31 PHASE4
NCT02763007 TERMINATED
Diabetes Mellitus, Type 2
Kun-Ho Yoon
 2016-05-18 PHASE4
NCT02231021 COMPLETED
Type 2 Diabetes Mellitus
Kun-Ho Yoon
 2014-09 PHASE4
NCT03501277 COMPLETED
Healthy Volunteers
Takeda
 2018-05-26 PHASE1
NCT03501277 Completed
Healthy Volunteers
Takeda
 2018-05-26 Phase 1
NCT03231709 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2017-08-18 PHASE4
NCT03042325 WITHDRAWN
Diabetes Mellitus, Type 2
Takeda
 2017-07-30 PHASE4
NCT02771093 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2016-09-08 PHASE4
NCT02508168 COMPLETED
Healthy Volunteers
Takeda
 2016-04 PHASE1
NCT02426294 UNKNOWN
Type 2 Diabetes Mellitus
Pusan National University Hospital
 2015-02 PHASE4
NCT01890122 COMPLETED
Diabetes Mellitus
Takeda
 2013-09 PHASE3
NCT02798172 COMPLETED
Diabetes Mellitus, Type 2
Fourth People's Hospital of Shenyang
 2014-05
NCT02683226 COMPLETED
Polycystic Ovary Syndrome; Insulin Resistance
University Medical Centre Ljubljana
 2015-03 PHASE4
NCT02068443 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2014-02 PHASE3
NCT02276274 COMPLETED
Clinical Pharmacology
Takeda
 2014-06 PHASE3
NCT02276274 Completed
Clinical Pharmacology
Takeda
 2014-06 Phase 3
NCT01303055 UNKNOWN
Diabetes Mellitus, Type 2
Aichi Gakuin University
 2011-02
NCT01686711 COMPLETED
Diabetes Mellitus
Takeda
 2012-09 PHASE4
NCT00957268 COMPLETED
Diabetes Mellitus, Type 2
Takeda
 2009-09 PHASE1
NCT01632007 COMPLETED
Diabetes Mellitus
Takeda
 2012-05-01 PHASE3
NCT00968708 COMPLETED
Diabetes Mellitus, Type 2; Acute Coronary Syndrome
Takeda
 2009-09 PHASE3
NCT01521962 COMPLETED
Diabetes Mellitus
Takeda
 2012-02 PHASE3
NCT01456130 COMPLETED
Diabetes Mellitus
Takeda
 2011-11 PHASE3
NCT01664624 COMPLETED
Type 2 Diabetes
AstraZeneca
 2012-07 PHASE1
NCT00856284 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2009-03 PHASE3
NCT01289119 COMPLETED
Diabetes Mellitus, Type 2
Takeda
 2010-12 PHASE3
NCT00306384 COMPLETED
Diabetes Mellitus
Takeda
 2006-03 PHASE3
NCT01391663 COMPLETED
Pharmacokinetics and Pharmacodynamics
Takeda
 2011-07 PHASE1
NCT01023581 COMPLETED
Diabetes Mellitus, Type 2
Takeda
 2009-11 PHASE3
NCT00707993 COMPLETED
Diabetes Mellitus
Takeda
 2008-06 PHASE3
NCT01318135 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2009-01 PHASE2; PHASE3
NCT00655863 COMPLETED
Diabetes Mellitus
Takeda
 2007-07 PHASE3
NCT00957268 Completed
Diabetes Mellitus Type 2
Takeda
 2009-09 Phase 1
NCT01318122 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2008-05 PHASE2; PHASE3
NCT00432276 COMPLETED
Diabetes Mellitus
Takeda
 2007-01 PHASE3
NCT01318109 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2008-08 PHASE2; PHASE3
NCT01318083 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2008-08 PHASE2; PHASE3
NCT01263509 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2007-06 PHASE2; PHASE3
NCT01318070 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2007-11 PHASE2; PHASE3
NCT01263496 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2007-05 PHASE2
NCT01263483 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2007-01 PHASE2; PHASE3
NCT00328627 COMPLETED
Type 2 Diabetes Mellitus
Takeda
 2006-05 PHASE3
NCT00395512 COMPLETED
Diabetes Mellitus
Takeda
 2006-11 PHASE3
NCT01263470 COMPLETED
Diabetes Mellitus, Type 2
Takeda
 2007-01 PHASE2
NCT00286494 COMPLETED
Diabetes Mellitus
Takeda
 2006-02 PHASE3
NCT00286455 COMPLETED
Diabetes Mellitus
Takeda
 2006-02 PHASE3
NCT00286468 COMPLETED
Diabetes Mellitus
Takeda
 2006-04 PHASE3
NCT00286442 COMPLETED
Diabetes Mellitus
Takeda
 2006-03 PHASE3
NCT00286429 COMPLETED
Diabetes Mellitus
Takeda
 2006-02 PHASE3
NCT00763347 TERMINATED
Diabetes Mellitus
Takeda
 2006-11 PHASE2
NCT00755846 COMPLETED
Diabetes Mellitus
Takeda
 2005-03 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-24)

Check the Alogliptin (SYR-322) benzoate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alogliptin selectively binds to dipeptidyl peptidase-4 (DPP-4), preventing the enzymatic degradation of active incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). This sustained elevation of endogenous incretin levels enhances glucose-dependent insulin secretion and suppresses glucagon release from pancreatic islet cells, providing therapeutic efficacy in clinical trials evaluating type 2 diabetes mellitus and metabolic disorders like non-alcoholic steatohepatitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.