TheraRadar
Data updated: May 26, 2026

NESINA (alogliptin benzoate)

Genetically Validated
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.

3
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2013-01-25
Patent Cliff
2029

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Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: ALOGLIPTIN BENZOATE

NESINA Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
39 FDA actions from 2013 to 2023 · 2 indication expansions
Jul 2023 SUPPL
Efficacy
Mar 2022 SUPPL
Label · Labeling
Jul 2019 SUPPL
Label · Labeling

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.

What's emerging in NESINA's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NESINA treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to NESINA

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BYETTA
EXENATIDE SYNTHETIC
1 shared
AstraZeneca
Shared indications:
Type 2 diabetes mellitus
GLIPIZIDE
GLIPIZIDE
1 shared
PHARMOBEDIENT
Shared indications:
Type 2 diabetes mellitus
GLYBURIDE AND METFORMIN HYDROCHLORIDE
GLYBURIDE
1 shared
IMPAX LABS INC
Shared indications:
Type 2 diabetes mellitus
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02856113 results posted SYR-322_309 U1111-1174-1923, 2015-000208-25 Ph 3 completed Phase 3 Alogliptin Pediatric Study
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Active Pipeline

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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

Indications & Usage

FDA Label (PDF)

NESINA is indicated for the treatment of Type 2 diabetes mellitus.

View full patent landscape →
2 OB patents · 2 families · 110 international docs across 39 countries

NESINA Patents & Exclusivity

Latest Patent: Jun 2029
Exclusivity: Jul 2026

Patents (2 active)

US8697125 Expires Jun 16, 2029
US7807689 Expires Jun 27, 2028

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
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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Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2029
  • 18 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 6 similar drugs
  • Same target/indication analysis
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Data Sources

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