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Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

NESINA

ALOGLIPTIN BENZOATE
Metabolic Approved 2013-01-25

Nesina is 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. It is used to manage blood glucose levels in the adult patient population. The medication is not recommended for the treatment of patients with type 1 diabetes mellitus.

Source: FDA Label • Takeda

How NESINA Works

Alogliptin selectively binds to and inhibits the enzyme DPP-4, which normally inactivates incretin hormones such as GLP-1 and GIP. By slowing this inactivation, the drug increases the bloodstream concentrations of these hormones, which stimulate insulin release from pancreatic beta cells in a glucose-dependent manner. Additionally, increased GLP-1 levels lower glucagon secretion, leading to reduced hepatic glucose production and lower fasting and postprandial glucose concentrations.

Source: FDA Label
3
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2013-01-25
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: ALOGLIPTIN BENZOATE

NESINA Approval History

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What NESINA Treats

1 indications

NESINA is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Type 2 diabetes mellitus
Source: FDA Label

NESINA Target & Pathway

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Target

GLP-1 (Glucagon-Like Peptide-1) Incretin Receptor

A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.

NESINA Competitors

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6 other drugs also target GLP-1. Compare mechanisms, indications, and trial activity.

Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (GLP-1). Earlier expiry dates signal biosimilar/generic opportunities.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NESINA FDA Label Details

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Indications & Usage

FDA Label (PDF)

NESINA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. NESINA is 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. Limitations of Use: Should not be used in patients with type 1 diabetes mellitus. Limitations of Use NESINA is not recommended for use in patients with type 1 diabetes mellitus.

NESINA Patents & Exclusivity

Latest Patent: Jun 2029
Exclusivity: Jul 2026

Patents (18 active)

US8697125 Expires Jun 16, 2029
US7807689 Expires Jun 27, 2028
+ 8 more patents

Exclusivity

M-300 Until Jul 2026
M-300 Until Jul 2026
M-300 Until Jul 2026
M-300 Until Jul 2026
M-300 Until Jul 2026
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.