Alogliptin

Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the dipeptidyl peptidase-4 (DPP-4) enzyme within minutes.

• Alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14) ]. Alogliptin tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.ICD-10: E11.9

• Serious hypersensitivity reaction to alogliptin or any of the excipients in Alogliptin tablets. Reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) ] .contraindicated

The recommended dose in patients with normal renal function or mild renal impairment is 25 mg once daily. ( 2.1 ) Can be taken with or without food. ( 2.1 ) Adjust dose if moderate or severe renal impairment or end-stage renal disease (ESRD). ( 2.2 ) Degree of Renal Impairment Creatinine Clearance (mL/min) Recommended Dosing Moderate ≥30 to <60 12.5 mg once daily Severe/ESRD <30 6.25 mg once daily 2.1 Recommended Dosing The recommended dose of alogliptin tablets is 25 mg once daily. Alogliptin tablets may be taken with or without food. Do not split tablets. 2.2 Patients with Renal Impairment No dose adjustment of alogliptin tablets is necessary for patients with mild renal impairment (creatinine clearance [CrCl] ≥60 mL/min). The dose of alogliptin tablets is 12.5 mg once daily for patients with moderate renal impairment (CrCl ≥30 to <60 mL/min). The dose of alogliptin tablets is 6.25 mg once daily for patients with severe renal impairment (CrCl ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis). Alogliptin tablets may be administered without regard to the timing of dialysis. Alogliptin tablets have not been studied in patients undergoing peritoneal dialysis [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ]. Because there is a need for dose adjustment based upon renal function, assessment of renal function is recommended prior to initiation of alogliptin tablets therapy and periodically thereafter.

Pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue alogliptin tablets. ( 5.1 ) Heart failure: Consider the risks and benefits of alogliptin tablets prior to initiating treatment in patients at risk for heart failure. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of alogliptin tablets ( 5.2 ). Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with alogliptin tablets such as anaphylaxis, angioedema and severe cutaneous adverse reactions, including Stevens-Johnson syndrome. In such cases, promptly discontinue alogliptin tablets, assess for other potential causes, institute appropriate monitoring and treatment and initiate alternative treatment for diabetes. ( 5.3 ) Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt alogliptin tablets and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart alogliptin tablets if liver injury is confirmed and no alternative etiology can be found. ( 5.4 ) Hypoglycemia: When an insulin secretagogue (e.g., sulfonylurea) or insulin is used in combination with alogliptin tablets, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia.

The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Hepatic Effects [see Warnings and Precautions (5.4) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] Bullous Pemphigoid [see Warnings and Precautions (5.7) ] The most common adverse reactions (4% or greater incidence) are nasopharyngitis, headache and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 14,778 patients with type 2 diabetes participated in 14 randomized, double-blind, controlled clinical trials of whom 9052 subjects were treated with alogliptin tablets, 3469 subjects were treated with placebo and 2257 were treated with an active comparator. The mean duration of diabetes was seven years, the mean body mass index (BMI) was 31 kg/m 2 (49% of patients had a BMI ≥30 kg/m 2 ), and the mean age was 58 years (26% of patients ≥65 years of age).

8.1 Pregnancy Risk Summary Limited data with alogliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ]. No adverse developmental effects were observed when alogliptin was administered to pregnant rats and rabbits during organogenesis at exposures 180- and 149-times the 25 mg clinical dose, respectively, based on plasma drug exposure (AUC) [see Data ] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.

Metabolism

The pharmacokinetics of alogliptin tablets has been studied in healthy subjects and in patients with type 2 diabetes. After administration of single, oral doses up to 800 mg in healthy subjects, the peak plasma alogliptin concentration (median T max ) occurred one to two hours after dosing.

In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status. Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract. Alogliptin is minimally dialyzable; over a three-hour hemodialysis session, approximately 7% of the drug was removed. Therefore, hemodialysis is unlikely to be beneficial in an overdose situation. It is not known if alogliptin tablets are dialyzable by peritoneal dialysis. To contact the poison control center, call 1-800-222-1222.

• Jan 25, 2013NDANDA022426Takeda Pharms Usa
• Jan 25, 2013NDANDA203414Takeda Pharms Usa
• Jan 25, 2013NDANDA022271Takeda Pharms Usa

1. 1Diarrhoea1453.9%
2. 2Nausea1383.7%
3. 3Vomiting1193.2%
4. 4Rash1113.0%
5. 5Acute Kidney Injury1082.9%
6. 6Blood Glucose Increased1012.7%
7. 7Malaise1012.7%
8. 8Pemphigoid1012.7%
9. 9Dyspnoea992.6%
10. 10Drug Ineffective962.6%
11. 11Dizziness872.3%
12. 12Pneumonia872.3%
13. 13Fatigue852.3%
14. 14Pruritus832.2%
15. 15Headache822.2%

The 10 most recently updated of 89 ClinicalTrials.gov registrations naming Alogliptin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
  Active not recruiting · Observational · 781,430 enrolled · Brigham and Women's Hospital
  NCT05220917updated 2026-05-15
• The Effect of Alogliptin Combined With Actoplus Met on Glucose and Lipid Metabolism and Pancreatic Function in Patients With T2DM Complicated With MAFLD
  Not yet recruiting · Phase 4 · Interventional · 80 enrolled · The Fourth Affiliated Hospital of Zhejiang University School of Medicine
  NCT07289750updated 2026-03-24
• 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 · Phase 4 · Interventional · 133 enrolled · Celltrion Pharm, Inc.
  NCT03499704updated 2026-03-18
• Comparison of Type 2 Diabetes Pharmacotherapy Regimens
  Completed · Observational · 241,981 enrolled · Kaiser Permanente
  NCT05073692updated 2025-11-21
• A Bioequivalence Study of CT-L02 Compared to Co-administration (CTL0201 and CTL0202) in Healthy Volunteers
  Completed · Phase 1 · Interventional · 40 enrolled · Celltrion
  NCT07128654updated 2025-11-17
• Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors
  Completed · Observational · 742,670 enrolled · Brigham and Women's Hospital
  NCT05768945updated 2025-11-10
• Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
  Active not recruiting · Observational · 23,280,000 enrolled · Ohio State University
  NCT07188545updated 2025-09-23
• Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
  Recruiting · Phase 3 · Interventional · 171 enrolled · Celltrion
  NCT07093476updated 2025-08-11
• A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
  Completed · Observational · 714,582 enrolled · Janssen Research & Development, LLC
  NCT03492580updated 2025-06-25
• A Study to Assess the Safety and Efficacy of ASP1941 in Combination With Dipeptidyl Peptidase-4 (DPP-4) Inhibitor in Type 2 Diabetic Patients
  Completed · Phase 3 · Interventional · 106 enrolled · Astellas Pharma Inc
  NCT01242228updated 2025-05-30

Frequently asked questions

How does Alogliptin work?

Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the dipeptidyl peptidase-4 (DPP-4) enzyme within minutes.

What is Alogliptin used for?

According to FDA labeling, Alogliptin carries indications including: Alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14) ]. Alogliptin tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Alogliptin?

Alogliptin is classified as Dipeptidyl peptidase 4 (DPP-4) inhibitors, Dipeptidyl Peptidase 4 Inhibitor, Dipeptidyl Peptidase 4 Inhibitors, Peptide Metabolism Alteration.

What are the brand names for Alogliptin?

Alogliptin is marketed under brand names including Kazano, Nesina, Oseni.

What are the contraindications for Alogliptin?

Alogliptin labeling lists contraindications including: Serious hypersensitivity reaction to alogliptin or any of the excipients in Alogliptin tablets. Reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) ] .. Always consult the full prescribing information and a clinician.