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Drug

Alogliptin

Approved · EMA
Emerging researchLate-stage developmentRising momentum
Also known as Alogliptin-Metformin, Alogliptin-Pioglitazone, Kazano, Nesina+4 more

Alogliptin-Metformin, Alogliptin-Pioglitazone, Kazano, Nesina, Oseni, Alogliptina, Alogliptine, Alogliptinum.

RxNorm1368001ChEMBLCHEMBL376359UNIIJHC049LO86
3
Research papers
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin

Clinical trial2025-08-11Results expected Q4 2026 · ClinicalTrials.gov

A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy

Clinical trial2024-01-16Completed · ClinicalTrials.gov

Treatment Preference for Weekly DPP-4 Inhibitors Versus Daily DPP-4 Inhibitors in Patients With Type 2 Diabetes Mellitus

Clinical trial2023-12-22Results posted · ClinicalTrials.gov

An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus

Clinical trial2023-12-12Results posted · ClinicalTrials.gov

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study When Metformin Hydrochloride 500 mg is Added on to SYR-322 25 mg in Type 2 Diabetic Patients

Clinical trial2023-09-28Results posted · ClinicalTrials.gov

A Multi-center, Randomized, Double-blind, Placebo/Positive Parallel Phase III Clinical Trial to Evaluate the Efficacy and Safety of SAL067 in Type 2 Diabetes Patients Who Cannot Effectively Control Blood Glucose Through Diet and Exercise

Clinical trial2022-03-25Completed · ClinicalTrials.gov

Efficacy and Safety of Alogliptin vs. Acarbose in Chinese T2DM Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive: A Multicenter, Randomized, Open Label, Prospective Study

Clinical trial2020-12-14Completed · ClinicalTrials.gov

A Randomized, Open-Label, Single-Dose, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin (25 mg) and Pioglitazone (15 and 30 mg) When Administered as Individual Tablets and as Fixed-Dose Combination Tablets to Healthy Russian Subjects

Clinical trial2019-08-08Results posted · ClinicalTrials.gov

Approval: Vipidia (EMA)

Regulatory2013-09-18EMA

Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study.

Research2012-01-12Diabetologia

Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies.

Research2009-09-30Journal of the American Geriatrics Society

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study.

Research2008-09-22Diabetes care

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Improves HbA1c in type 2 diabetes
74%Moderate confidence
Uncertainty ±12%Evidence coverage: HighUpdated 16 January 2024

Confidence is moderate because multiple independent trials consistently report HbA1c, with a narrow uncertainty band; publication incorporation remains limited.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Alogliptin
Aliases & brands
Alogliptin-MetforminAlogliptin-PioglitazoneKazanoNesinaOseniAlogliptinaAlogliptineAlogliptinum
RxNorm CUI
1368001
ChEMBL ID
CHEMBL376359
UNII
JHC049LO86
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-09-18
Latest approval
2013-09-18
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2013-09-18Approval
Approval: Vipidia (EMA)
Indication: Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products… Show full indication

Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

36 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
36
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
27
Late-stage (III+)
30
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 36
Phase 15Phase 24Phase 318Phase 48Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy

CompletedPH IVCelltrion Pharm, Inc.n=1332024

Comparison of Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination in Poorly Controlled Type 2 Diabetic Patients

Unknown statusPH IVSeoul National University Hospitaln=992021

Efficacy and Safety of Alogliptin vs. Acarbose in Chinese T2DM Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive: A Multicenter, Randomized, Open Label, Prospective Study

CompletedPH IVKey trialSanofin=1,2932020

An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients

TerminatedPH IVKun-Ho Yoonn=412019

Multicenter, Randomized, Double Blind, Three-arm Parallel Group Study to Evaluate Efficacy and Safety of Alogliptin and Pioglitazone Combination Therapy on Glucose Control in Type 2 Diabetes Subjects Who Have Inadequate Control With Metformin Monotherapy in Korea

CompletedPH IVKun-Ho Yoonn=2162019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy

CompletedPH IVCelltrion Pharm, Inc.n=1332024

A Multi-center, Randomized, Double-blind, Placebo/Positive Parallel Phase III Clinical Trial to Evaluate the Efficacy and Safety of SAL067 in Type 2 Diabetes Patients Who Cannot Effectively Control Blood Glucose Through Diet and Exercise

CompletedPH IIIShenzhen Salubris Pharmaceuticals Co., Ltd.n=4582022

Efficacy and Safety of Alogliptin vs. Acarbose in Chinese T2DM Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive: A Multicenter, Randomized, Open Label, Prospective Study

CompletedPH IVKey trialSanofin=1,2932020

Multicenter, Randomized, Double Blind, Three-arm Parallel Group Study to Evaluate Efficacy and Safety of Alogliptin and Pioglitazone Combination Therapy on Glucose Control in Type 2 Diabetes Subjects Who Have Inadequate Control With Metformin Monotherapy in Korea

CompletedPH IVKun-Ho Yoonn=2162019

A Randomized, Open-Label, Single-Dose, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin (25 mg) and Pioglitazone (15 and 30 mg) When Administered as Individual Tablets and as Fixed-Dose Combination Tablets to Healthy Russian Subjects

CompletedPH ITakedan=722018

Treatment Preference for Weekly DPP-4 Inhibitors Versus Daily DPP-4 Inhibitors in Patients With Type 2 Diabetes Mellitus

CompletedPH IVTakedan=602018

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20082012
Journals, researchers & institutions
Top journals
  • Diabetes care1
  • Diabetologia1
  • Journal of the American Geriatrics Society1
Leading researchers
  • Fleck PR2
  • Mekki Q2
  • Wilson CA2
  • Cederholm J1
  • DeFronzo RA1
  • Diamant M1
  • Eeg-Olofsson K1
  • Eliasson B1
Leading institutions
free-text, unnormalised
  • College of Medicine1
  • Department of Molecular and Clinical Medicine1
  • University of Texas Health Science Center at San Antonio1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.