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 (insulin lispro) by Eli Lilly and Company. Approved for insulin analog [epc]. First approved in 1999.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HUMALOG MIX 50/50 is a fixed-ratio insulin lispro blend combining rapid-acting and intermediate-acting insulin for glycemic control in Type 1 and Type 2 Diabetes. It works by stimulating peripheral glucose uptake in muscle and fat while inhibiting hepatic glucose production. This premixed formulation simplifies dosing for patients requiring both basal and bolus insulin coverage.
LOE Approaching
Product facing patent expiration pressure; commercial teams should expect declining market exclusivity and intensified generic competition within 2-3 years.
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.