Nesina

(Alogliptin)

ApprovedSmall molecule

Alogliptin is used to help control blood sugar levels in people with type 2 diabetes. It works by helping the pancreas release more insulin when blood sugar is high.[2] Nesina is currently approved and in use across 4 indications[4].[1]

Nesina is one of 115 small molecule programs targeting Acute Coronary Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

114

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Acute Coronary SyndromeActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

Diabetes MellitusActive, not recruiting

Type 2 DiabetesActive, not recruiting

Acute Coronary SyndromePhase 3

Active, not recruiting

Type 2 Diabetes MellitusApproved

Active, not recruiting

Diabetes MellitusApproved

Active, not recruiting

Type 2 DiabetesPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Nesina

Takeda

Approved

22 2

Byetta

AstraZeneca

Preclinical

55 3

NOVOLIN R

Novo Nordisk

Preclinical

5 4

Aurlumyn

BBTG International Inc.

Preclinical

1 5

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

1 6

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

1 7

Lovaza

AstraZeneca

Preclinical

1 8

Sulfonylureas

Eli Lilly

Preclinical

1 9

Blank Control

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Preclinical

1 10

Antiplatelet Drug

FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Type 2 Diabetes

NCT07093476

Clinical

Trials by Indication[1]

Type 2 Diabetes22 trials

Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2/3·NCT01263483·230 enrolled

Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2/3·NCT01263509·179 enrolled

Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2/3·NCT01318135·576 enrolled

Show 19 more trials

Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2/3·NCT01318122·336 enrolled

Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2/3·NCT01318109·288 enrolled

A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea

Completed· Takeda logo

Takeda··NCT04980040·3,623 enrolled

Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

Completed· Takeda logo

Takeda·Phase 3·NCT00286429·390 enrolled

Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2/3·NCT01318083·312 enrolled

Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2/3·NCT01318070·339 enrolled

The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy

Completed·—·N/A·NCT02798172·81 enrolled

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2·NCT01263470·480 enrolled

Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

Completed· Takeda logo

Takeda·Phase 3·NCT01023581·784 enrolled

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

Completed· Takeda logo

Takeda·Phase 3·NCT01289119·506 enrolled

Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01664624·40 enrolled

Long-term Study of Alogliptin as an Add-on to Rapid-Acting Insulin Secretagogues in Type 2 Diabetes

Completed· Takeda logo

Takeda·Phase 3·NCT01456130·67 enrolled

Efficacy and Safety of Alogliptin and Metformin Fixed-Dose Combination in Participants With Type 2 Diabetes

Completed· Takeda logo

Takeda·Phase 3·NCT01890122·647 enrolled

SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Completed·SShenzhen Salubris Pharmaceuticals Co., Ltd.·Phase 3·NCT05782192·458 enrolled

Efficacy and Safety of Alogliptin in Subjects With Type 2 Diabetes

Completed· Takeda logo

Takeda·Phase 3·NCT00286455·329 enrolled

Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

Completed· Takeda logo

Takeda·Phase 3·NCT00655863·71 enrolled

Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

Completed· Takeda logo

Takeda·Phase 2·NCT00755846·265 enrolled

Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan

Completed· Takeda logo

Takeda·Phase 2·NCT01263496·438 enrolled

Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin

Recruiting·CCelltrion·Phase 3·NCT07093476·171 enrolled

Type 2 Diabetes Mellitus19 trials

Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive

Completed· Sanofi logo

Sanofi·Phase 4·NCT03794336·1,293 enrolled

Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 3·NCT00286494·493 enrolled

Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 3·NCT00286442·527 enrolled

Show 16 more trials

Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"

Completed· Takeda logo

Takeda··NCT03555565·1,026 enrolled

Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.

Completed· Takeda logo

Takeda·Phase 3·NCT00286468·500 enrolled

Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 4·NCT03231709·60 enrolled

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

Completed· Takeda logo

Takeda··NCT01945216·3,317 enrolled

A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy

Completed·CCelltrion Pharm, Inc.·Phase 4·NCT03499704·133 enrolled

Efficacy and Safety Study of SYR-619 in Treating Subjects With Type 2 Diabetes Mellitus

Terminated· Takeda logo

Takeda·Phase 2·NCT00763347·82 enrolled

Efficacy of Alogliptin and Pioglitazone in Subjects With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 3·NCT00432276·803 enrolled

Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus

Withdrawn· Takeda logo

Takeda·Phase 4·NCT03042325

Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 3·NCT00856284·2,639 enrolled

Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 1·NCT00957268·46 enrolled

An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 4·NCT02771093·27 enrolled

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"

Completed· Takeda logo

Takeda··NCT01945242·1,374 enrolled

Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda··NCT01964963·19,192 enrolled

Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 3·NCT00306384·3,323 enrolled

Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 3·NCT00395512·655 enrolled

Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.

Completed· Takeda logo

Takeda·Phase 3·NCT00328627·1,554 enrolled

MPA2 trials

A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers

Completed·CCelltrion·Phase 1·NCT05363384·48 enrolled

A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 12.5 mg and MET XR 500 mg) in Healthy Volunteers

Completed·CCelltrion·Phase 1·NCT05363592·48 enrolled

Type 2 Diabetic Patients2 trials

Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy

Completed· Takeda logo

Takeda·Phase 3·NCT02068443·374 enrolled

Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)"

Completed· Takeda logo

Takeda··NCT02221284·964 enrolled

Combination Therapy2 trials

The Practical Evidence of Antidiabetic Combination Therapy in Korea

Completed·KKun-Ho Yoon·Phase 4·NCT02231021·216 enrolled

Study of Combination Therapy With SYR-322

Completed· Takeda logo

Takeda·Phase 3·NCT01521962·67 enrolled

12 more indications

Efficacy and Safety1 trial

Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics

Completed· Takeda logo

Takeda·Phase 3·NCT00707993·441 enrolled

Pediatric1 trial

Phase 3 Alogliptin Pediatric Study

Completed· Takeda logo

Takeda·Phase 3·NCT02856113·152 enrolled

Diabetes Mellitus1 trial

An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2

Completed· Takeda logo

Takeda··NCT02756832·1,409 enrolled

Cancer1 trial

DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

Unknown status·NNagaoka Red Cross Hospital··NCT01588587·500 enrolled

ART1 trial

A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03501277·72 enrolled

Metformin1 trial

Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice

Terminated· Takeda logo

Takeda··NCT02989649·593 enrolled

Trial1 trial

An Extension Study of PEAK Trial

Terminated·KKun-Ho Yoon·Phase 4·NCT02763007·41 enrolled

Tics1 trial

Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants

Completed· Takeda logo

Takeda·Phase 1·NCT01391663·48 enrolled

Acute Coronary Syndrome1 trial

Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

Completed· Takeda logo

Takeda·Phase 3·NCT00968708·5,380 enrolled

Pancreatic1 trial

Effects of Alogliptin on Pancreatic Beta Cell Function

Unknown status·—·N/A·NCT01303055·80 enrolled

Phase 11 trial

Phase 1 Bioavailability Study of SYR-322MET

Completed· Takeda logo

Takeda·Phase 1·NCT02508168·24 enrolled

Double-blind1 trial

Double-blind Comparative Study of SYR-472

Completed· Takeda logo

Takeda·Phase 3·NCT01632007·245 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 25, 2013

NESINA

NDA NDA022271

Sources

References

[1]
ClinicalTrials.gov — 59 trial records for Alogliptin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nesina drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alogliptin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alogliptin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022271). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Nesina. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dipeptidyl Peptidase IV Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[6]

Patent Cliff

Jun 27, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7807689Jun 27, 2028

8697125Jun 16, 2029

Nesina

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Type 2 Diabetes22 trials

Type 2 Diabetes Mellitus19 trials

MPA2 trials

Type 2 Diabetic Patients2 trials

Combination Therapy2 trials

Efficacy and Safety1 trial

Pediatric1 trial

Diabetes Mellitus1 trial

Cancer1 trial

ART1 trial

Metformin1 trial

Trial1 trial

Tics1 trial

Acute Coronary Syndrome1 trial

Pancreatic1 trial

Phase 11 trial

Double-blind1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News