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Data updated: May 26, 2026

KIRSTY (insulin aspart-xjhz)

Metabolic Approved 2025-07-15

KIRSTY (insulin aspart-xjhz) is a rapid-acting human insulin analog. It is indicated to improve glycemic control in both adult and pediatric patients diagnosed with diabetes mellitus. The drug serves as a therapeutic intervention for managing blood sugar levels in these patient populations.

Source: FDA Label • BIOCON BIOLOGICS INC • Insulin Analog

How KIRSTY Works

KIRSTY regulates glucose metabolism by lowering blood glucose through the stimulation of peripheral glucose uptake, specifically in skeletal muscle and fat. It further reduces blood sugar levels by inhibiting the production of glucose within the liver. Additionally, the drug inhibits the breakdown of fats and proteins while enhancing protein synthesis.

1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-07-15
Routes
SOLUTION
Dosage Forms
INJECTION

Companies

Active Ingredient: INSULIN ASPART-XJHZ

KIRSTY Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Jul 2025 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What KIRSTY Treats

1 indications

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

  • Diabetes
Source: FDA Label
Auto-substitute OK for Fiasp

Pharmacists can substitute KIRSTY for Fiasp without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.

KIRSTY Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in KIRSTY's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KIRSTY 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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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.

KIRSTY FDA Label Details

Indications & Usage

FDA Label (PDF)

KIRSTY is indicated for the treatment of Diabetes.

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Data Sources

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