HUMALOG (insulin lispro recombinant)
HUMALOG is a rapid-acting human insulin analog indicated to improve glycemic control. It is approved for use in both adult and pediatric patients diagnosed with diabetes mellitus. The medication serves as a therapeutic intervention to manage blood sugar levels in these patient populations.
How HUMALOG Works
This drug regulates glucose metabolism by lowering blood glucose levels through several biological pathways. It stimulates peripheral glucose uptake in skeletal muscle and fat while simultaneously inhibiting the production of glucose in the liver. Additionally, it inhibits the breakdown of fats and proteins and enhances protein synthesis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-06-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HUMALOG Approval History
What HUMALOG Treats
1 indicationsHUMALOG is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
HUMALOG 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 HUMALOG's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HUMALOG treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03262116 results posted | 2017P001778 | Ph 2, Ph 3 | terminated | Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas |
| NCT04254380 GENTL 1 | GL-LSPT1-3003 | Ph 3 | withdrawn | Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro |
| NCT00774800 results posted | HZ2-08-05 HALO-117-201 | Ph 2 | completed | Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus |
| NCT02294474 SORELLA2 results posted | EFC13403 2014-002844-42, U1111-1156-4296 | Ph 3 | completed | Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine |
| NCT02273180 SORELLA1 results posted | EFC12619 2013-002945-12, U1111-1131-5038 | Ph 3 | completed | Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine |
| NCT01971047 | IRB00067662 | Ph 4 | withdrawn | Safety and Efficacy Study of Correcting Hyperglycemia in Patients With Diabetes Having Out-patient Surgery |
| 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 |
| NCT00916357 results posted | HALO-117-204 | Ph 2 | completed | Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM) |
| NCT01908894 | 3-101 | Ph 1 | completed | Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration |
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.
HUMALOG FDA Label Details
Indications & Usage
FDA Label (PDF)HUMALOG 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.
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