TheraRadar
Data updated: May 26, 2026

BRYNOVIN (sitagliptin hydrochloride)

Dipeptidyl Peptidase 4 Inhibitors Genetically Validated
Metabolic Approved 2025-01-16

Brynovin helps adults with type 2 diabetes manage their blood sugar levels when used alongside diet and exercise. It is prescribed to improve glycemic control by supporting the body's natural processes for regulating glucose. This medication is not intended for patients with type 1 diabetes or for those who have a history of pancreatitis.

Source: FDA Label • AZURITY • Dipeptidyl Peptidase 4 Inhibitor

How BRYNOVIN Works

This drug works by blocking the DPP-4 enzyme, which prevents the breakdown of incretin hormones that are naturally released after a meal. By keeping these hormones active for longer, the medication prompts the pancreas to release more insulin and signals the liver to produce less sugar. This process helps regulate blood sugar in a glucose-dependent manner, responding to the body's needs throughout the day.

1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2025-01-16
Patent Cliff
2040

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Routes
ORAL
Dosage Forms
SOLUTION

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Active Ingredient: SITAGLIPTIN HYDROCHLORIDE

BRYNOVIN Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Jan 2025 ORIGINAL
New Form · Type 3 - New Dosage Form

What BRYNOVIN Treats

1 indications

BRYNOVIN is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Type 2 Diabetes
Source: FDA Label

BRYNOVIN 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 BRYNOVIN's indications

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

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Active Pipeline

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Key Completed Trials

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Trial Timeline

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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.

BRYNOVIN FDA Label Details

Indications & Usage

FDA Label (PDF)

BRYNOVIN is indicated for the treatment of Type 2 Diabetes.

View full patent landscape →
2 OB patents · 1 families · 12 international docs across 5 countries

BRYNOVIN Patents & Exclusivity

Latest Patent: Oct 2040

Patents (2 active)

US12295953 Expires Oct 23, 2040
US11944621 Expires Oct 23, 2040
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2040
  • 2 active patents

Trial Analysis

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  • Development stage analysis

Competitive Landscape

  • 20 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.