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Insulin Lispro

Generic Name
Insulin Lispro
Brand Names
Admelog, Humalog, Humalog Mix, Humalog kwikpen, Liprolog, Lyumjev, Insulin lispro Sanofi, Lyumjev (previously Liumjev)
Drug Type
Biotech
CAS Number
133107-64-9
Unique Ingredient Identifier
GFX7QIS1II

Overview

Insulin lispro is a rapid-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin is prescribed for the management of diabetes mellitus to mimic the activity of endogenously produced human insulin, a peptide hormone produced by beta cells of the pancreas that promotes glucose metabolism. Insulin is released from the pancreas following a meal to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. Absorption of glucose into cells allows for its transformation into glycogen or fat for storage. Insulin also inhibits hepatic glucose production, enhances protein synthesis, and inhibits lipolysis and proteolysis among many other functions. Insulin is an important treatment in the management of Type 1 Diabetes (T1D) which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, resulting in the body not being able to produce the insulin needed to manage circulating blood sugar levels. As a result, people with T1D rely primarily on exogenous forms of insulin, such as insulin lispro, to lower glucose levels in the blood. Insulin is also used in the treatment of Type 2 Diabetes (T2D), another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors that promote chronically elevated blood sugar levels. Without treatment or improvement in non-pharmacological measures such as diet and exercise to lower blood glucose, high blood sugar eventually cause cellular resistance to endogenous insulin, and in the long term, damage to pancreatic islet cells. Insulin is typically prescribed later in the course of T2D, after several oral medications such as Metformin, Gliclazide, or Sitagliptin have been tried, and when sufficient damage has been caused to pancreatic cells that the body is no longer able to produce insulin on its own. Marketed as the brand name product Humalog, insulin lispro begins to exert its effects within 15 minutes of subcutaneous administration, while peak levels occur 30 to 90 minutes after administration. Due to its duration of action of around 5 hours, Humalog is considered "bolus insulin" as it provides high levels of insulin in a short period of time to mimic the release of endogenous insulin from the pancreas after meals. Bolus insulin is often combined with once daily, long-acting "basal insulin" such as Insulin detemir, Insulin degludec, or Insulin glargine to provide low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with a goal of avoiding any periods of hypoglycemia. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli and was the first commercially available insulin analog. Formerly called LYSPRO from the chemical nomenclature LYS(B28), PRO(B29), insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. These biochemical changes result in a reduced tendency for self-association resulting in dissolution to a dimer and then to a monomer that is absorbed more rapidly after subcutaneous injection compared to endogenous human insulin. Without an adequate supply of insulin to promote absorption of glucose from the bloodstream, blood sugar levels can climb to dangerously high levels and can result in symptoms such as fatigue, headache, blurred vision, and increased thirst. If left untreated, the body starts to break down fat, instead of glucose, for energy which results in a build-up of ketone acids in the blood and a syndrome called ketoacidosis, which is a life-threatening medical emergency. In the long term, elevated blood sugar levels increase the risk of heart attack, stroke, and diabetic neuropathy.

Indication

本品尤其适用于下列情况: 1.经常发生低血糖的1型糖尿病者,使用本品可减少低血糖的发生率; 2.生活不规律,外出活动较多的用胰岛素治疗的糖尿病患者,本品快速、短效的特点有助于及时调整胰岛素的用量。

Associated Conditions

  • Diabetes Mellitus
  • Diabetic Ketoacidosis
  • Gestational Diabetes Mellitus (GDM)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/07
Not Applicable
Not yet recruiting
2025/04/16
Phase 3
Active, not recruiting
Instituto de Oftalmología Fundación Conde de Valenciana
2025/01/09
Not Applicable
ENROLLING_BY_INVITATION
St. Peter's Hospital, Albany, NY
2024/08/01
Not Applicable
Recruiting
2024/04/17
Phase 4
Active, not recruiting
2024/02/28
Phase 1
Recruiting
2023/12/01
Phase 1
Completed
2023/09/21
Phase 2
Recruiting
McGill University Health Centre/Research Institute of the McGill University Health Centre
2023/06/08
Not Applicable
Completed
2023/04/28
Phase 3
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Eli Lilly and Company
0002-7510
INTRAVENOUS, SUBCUTANEOUS
100 [iU] in 1 mL
8/2/2023
Eli Lilly and Company
0002-7512
SUBCUTANEOUS
100 [iU] in 1 mL
7/21/2023
Eli Lilly and Company
0002-7714
SUBCUTANEOUS
100 [iU] in 1 mL
8/2/2023
Eli Lilly and Company
0002-8228
SUBCUTANEOUS
200 [iU] in 1 mL
3/29/2023
Eli Lilly and Company
0002-7752
SUBCUTANEOUS
100 [iU] in 1 mL
7/21/2023
Eli Lilly and Company
0002-8351
SUBCUTANEOUS
100 [iU] in 1 mL
3/29/2023
REMEDYREPACK INC.
70518-2264
INTRAVENOUS, SUBCUTANEOUS
100 [iU] in 1 mL
8/13/2019
Eli Lilly and Company
0002-8798
SUBCUTANEOUS
100 [iU] in 1 mL
7/21/2023
Eli Lilly and Company
0002-8233
SUBCUTANEOUS
100 [iU] in 1 mL
7/21/2023
Eli Lilly and Company
0002-7728
INTRAVENOUS, SUBCUTANEOUS
100 [iU] in 1 mL
3/29/2023

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LYUMJEV TEMPO PEN
eli lilly canada inc
02520222
Solution - Intravenous ,  Subcutaneous
300 UNIT / 3 ML
N/A
LYUMJEV KWIKPEN
eli lilly canada inc
02520230
Solution - Subcutaneous
600 UNIT / 3 ML
N/A
LIPRELOG
eli lilly canada inc
02513331
Solution - Subcutaneous
100 UNIT / ML
N/A
ADMELOG
sanofi-aventis canada inc
02469901
Solution - Subcutaneous
100 UNIT / ML
11/22/2019
ADMELOG
sanofi-aventis canada inc
02469898
Solution - Subcutaneous
100 UNIT / ML
11/22/2019
HUMALOG
eli lilly canada inc
02470152
Solution - Subcutaneous
100 UNIT / ML
4/6/2018
HUMALOG PEN
eli lilly canada inc
02241283
Liquid - Intramuscular ,  Subcutaneous ,  Intravenous
100 UNIT / ML
1/10/2000
HUMALOG 200 UNITS/ML KWIKPEN
eli lilly canada inc
02439611
Solution - Subcutaneous
200 UNIT / ML
9/14/2015
LIPRELOG
eli lilly canada inc
02513374
Solution - Subcutaneous
100 UNIT / ML
N/A
HUMALOG MIX 25 (PEN)
eli lilly canada inc
02240295
Suspension - Subcutaneous
75 UNIT / ML
1/10/2000

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
LYUMJEV 100 unidades/ml TEMPO PEN SOLUCION INYECTABLE EN PLUMA PRECARGADA
1201422016
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
HUMALOG JUNIOR KWIKPEN 100 UNIDADES/ML SOLUCION INYECTABLE EN PLUMA PRECARGADA
196007044
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
LYUMJEV 100 unidades/ml JUNIOR KWIKPEN SOLUCION INYECTABLE EN PLUMA PRECARGADA
1201422011
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
HUMALOG MIX50 KWIKPEN 100 U/ml SUSPENSION INYECTABLE
96007035
SUSPENSIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
HUMALOG MIX25 KWIKPEN 100 U/ml SUSPENSION INYECTABLE
96007033
SUSPENSIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
LYUMJEV 100 unidades/ml SOLUCION INYECTABLE EN VIAL
1201422001
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
HUMALOG 100 U/ml, SOLUCION INYECTABLE EN CARTUCHO
96007004
SOLUCIÓN INYECTABLE EN CARTUCHO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
HUMALOG 100 U/ml, SOLUCION INYECTABLE EN VIALES
96007002
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
HUMALOG KWIKPEN 200 UNIDADES/ML, SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
196007041
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
HUMALOG KWIKPEN 100 U/ml, SOLUCION INYECTABLE
96007031
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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