LANTUS (insulin glargine recombinant)
Lantus is a long-acting human insulin analog indicated to improve glycemic control in both adult and pediatric patients with diabetes mellitus. As a basal insulin, it provides sustained regulation of blood sugar levels. However, it is not recommended for the treatment of diabetic ketoacidosis.
How LANTUS Works
Lantus regulates glucose metabolism by lowering blood glucose levels through multiple pathways. It stimulates peripheral glucose uptake, particularly in skeletal muscle and fat, while simultaneously inhibiting the production of glucose by the liver. Furthermore, the medication inhibits the processes of lipolysis and proteolysis and enhances protein synthesis within the body.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-04-20
- Patent Cliff
- 2016
- Revenue
- $463M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LANTUS Approval History
What LANTUS Treats
1 indicationsLANTUS is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
LANTUS 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 LANTUS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LANTUS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LANTUS
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03555305 results posted | 13877 I4L-MC-ABEF | Ph 1 | completed | A Study of Insulin Glargine (LY2963016) in Healthy Chinese Participants |
| NCT02514850 | BC3-CT018 | Ph 1 | completed | A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties of Biochaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes |
| NCT00767000 results posted | 0941-007 2008_557 | Ph 2 | terminated | Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED) |
| NCT01421459 ELEMENT 2 results posted | 13713 I4L-MC-ABEC, 2011-000828-15 | Ph 3 | completed | A Study in Adults With Type 2 Diabetes |
| NCT01421147 ELEMENT 1 results posted | 13712 I4L-MC-ABEB, 2011-000829-73 | Ph 3 | completed | A Study in Adults With Type 1 Diabetes |
| NCT01600950 results posted | 13831 I4L-MC-ABEE | Ph 1 | completed | A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus |
| NCT01374178 results posted | 14094 I4L-MC-ABEI | Ph 1 | completed | A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects |
| NCT01476345 results posted | 13711 I4L-MC-ABEA | Ph 1 | completed | A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY2963016 to Lantus in Healthy Participants |
| NCT01634165 results posted | 14676 I4L-MC-ABEM | Ph 1 | completed | A Study of LY2963016 in Healthy Participants |
| NCT00943709 | 060601 AVENTIS-CINJ-060601, 0220070268 | Ph 3 | withdrawn | Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia |
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.
LANTUS FDA Label Details
Indications & Usage
FDA Label (PDF)LANTUS is indicated for the treatment of Diabetes.
Pro Intelligence Preview
Deep insights for LANTUS
Revenue Insights
- • Q4-2025: $463M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2016
- • Generic/biosimilar risk
Trial Analysis
- • 21 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment