SEMGLEE (insulin glargine-yfgn) · Viatris
Semglee is a long-acting human insulin analog indicated to improve glycemic control in patients with diabetes mellitus. The medication is approved for use in both adult and pediatric populations to manage blood sugar levels. It is not recommended for the treatment of diabetic ketoacidosis.
How SEMGLEE Works
This insulin analog functions by regulating glucose metabolism through several biological pathways. It lowers blood glucose by stimulating peripheral glucose uptake in skeletal muscle and fat while inhibiting the liver's production of glucose. Furthermore, it inhibits the processes of lipolysis and proteolysis and promotes protein synthesis.
Details
- Status
- Prescription
- First Approved
- 2020-06-11
- Patent Cliff
- 2022
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SEMGLEE Approval History
What SEMGLEE Treats
2 indicationsSEMGLEE is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
- Diabetic Ketoacidosis
Pharmacists can substitute SEMGLEE for Basaglar without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
SEMGLEE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 SEMGLEE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SEMGLEE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SEMGLEE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
SEMGLEE FDA Label Details
Indications & Usage
FDA Label (PDF)SEMGLEE is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use SEMGLEE is not recommended for the treatment of diabetic ketoacidosis. SEMGLEE is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use Not recommended for the treatment of diabetic ketoacidosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.