BLAINJECTIONINJECTABLE10 Generics Approved
Approved
Jun 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
HUMALOG TEMPO PEN (insulin lispro) by Eli Lilly and Company. Approved for insulin analog [epc]. First approved in 1996.
Drug data last refreshed 3d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Humalog Tempo Pen is a rapid-acting insulin lispro analog administered via subcutaneous injection for Type 1 and Type 2 Diabetes Mellitus. It lowers blood glucose by stimulating peripheral glucose uptake and inhibiting hepatic glucose production, while suppressing lipolysis and proteolysis. The Tempo Pen formulation represents a device innovation within the established insulin lispro class.
LOE Approaching
As loss of exclusivity approaches, the brand team is transitioning from growth to defensive strategy, with emphasis on device differentiation and patient loyalty programs rather than expansion.
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.