BLAINJECTIONINJECTABLE10 Generics Approved
Approved
Dec 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
HUMALOG MIX 50/50 PEN (insulin lispro) by Eli Lilly and Company. Approved for insulin analog [epc]. First approved in 1999.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HUMALOG MIX 50/50 PEN is a rapid-acting insulin lispro analog administered by injection for Type 1 and Type 2 diabetes mellitus, chronic kidney disease, and acute myocardial infarction. It works by stimulating peripheral glucose uptake in muscle and fat while inhibiting hepatic glucose production, lipolysis, and proteolysis. The 50/50 formulation combines rapid-acting and intermediate-acting insulin for flexible dosing throughout the day.
LOE Approaching
Facing moderate competitive pressure (30/100) in a market dominated by GLP-1 agonists and SGLT2 inhibitors; brand teams should anticipate contraction and focus on retention and lifecycle extension strategies.
Mechanism of Action
Pharmacologic Class:
Insulin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec
Started Jan 2024
227 enrolled
Diabetes Mellitus, Type 1
A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes
Started Feb 2022
25 enrolled
Diabetes Mellitus, Type 1
A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin
Started Oct 2020
1,428 enrolled
Type 2 Diabetes
A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus
Started Aug 2020
32 enrolled
Type 1 Diabetes
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Started Feb 2020
32 enrolled
Diabetes Mellitus, Type 1
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.