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Humalog (INSULIN LISPRO)
Humalog works by mimicking the natural hormone insulin to help cells absorb glucose from the bloodstream.
Humalog (INSULIN LISPRO) is a small molecule insulin drug developed by Lilly, targeting the insulin receptor to treat diabetes mellitus type 1 and type 2. It was FDA approved in 1996 and remains a branded product under Lilly's ownership. As a fast-acting insulin, Humalog helps regulate blood sugar levels after meals. Key safety considerations include the risk of hypoglycemia and allergic reactions. Commercially, Humalog is a patented product with no generic manufacturers available.
At a glance
| Generic name | INSULIN LISPRO |
|---|---|
| Sponsor | Eli Lilly |
| Drug class | Insulin Analog [EPC] |
| Target | Insulin receptor |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1996 |
| Annual revenue | 2200 |
Mechanism of action
The primary activity of insulin, including Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, is the regulation of glucose metabolism. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.
Approved indications
- Diabetes mellitus type 1
- Diabetes mellitus type 2
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
Drug interactions
- antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics
- atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones
- alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
- beta-blockers, clonidine, guanethidine, and reserpine
Key clinical trials
- Impact on Birth Weight of Two Therapeutic Strategies (Insulin Therapy From the Beginning of Pregnancy vs. Insulin Therapy Initiated According to Fetal Growth Evaluated by Ultrasonography Measurements) in Pregnant Women With Monogenic Diabetes (NA)
- Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (NA)
- Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes (PHASE2)
- Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor
- A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes (PHASE1)
- Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog® (PHASE1)
- Oral Anti Diabetic Agents in the Hospital (PHASE4)
- Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Humalog CI brief — competitive landscape report
- Humalog updates RSS · CI watch RSS
- Eli Lilly portfolio CI