Insulin lispro
Highest phase reached
Approved
Drug type
Protein
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Insulin lispro
- humalog
- Humalog
- ins humalog
- Ins humalog
- insulin lispro sanofi
- Insulin lispro sanofi
- liprolog
- Liprolog
- Lyumjev (previously liumjev)
- lyumjev previously liumjev
- 28 sup b l lysine 29 sup b l prolineinsulin human
- 28(SUP B)-L-LYSINE-29(SUP B)-L-PROLINEINSULIN (HUMAN)
- admelog
- ADMELOG
- admelog solostar
- ADMELOG SOLOSTAR
- csii insulin lispro
- CSII(insulin Lispro)
- Humalog
- Humalog®
- identical to human insulin except for the transposition of proline and lysine at positions 28 and 29 on the b chain
- IDENTICAL TO HUMAN INSULIN EXCEPT FOR THE TRANSPOSITION OF PROLINE AND LYSINE AT POSITIONS 28 AND 29 ON THE B CHAIN
- INSULIN (HUMAN), 28(SUP B)-L-LYSINE-29(SUP B)-L-PROLINE-
- insulin b28 lys b29 pro recombinant human protamine sulphate
- INSULIN B28(LYS)-B29(PRO) RECOMBINANT HUMAN/PROTAMINE SULPHATE
- insulin human 28 sup b l lysine 29 sup b l proline
- insulin lispro
- Insulin lispro
- Insulin Lispro
- Insulin LISPRO
- INSULIN LISPRO (GENETICAL RECOMBINATION)
- Insulin Lispro (Humalog U-100)
- Insulin lispro (Humalog)
- Insulin Lispro (Humalog)
- Insulin Lispro (Humalog®)
And 83 more, listed on the interactive page.
- CAS registry numbers
- 133107-64-9
- ChEMBL ID
- CHEMBL1201538
- PubChem compound IDs
- 118984450
- RxNorm IDs (RxCUI)
- 86009
- FDA ingredient codes (UNII)
- GFX7QIS1II
- A10AB04
- A10AC04
- A10AD04
Sources for recorded values
- Applicant
- LILLY
- Approval date
- 14 Jun 1996
- Application number
- BLA020563
- Status
- Authorised
- Status date
- 30 Apr 1996
- Authorisation date
- 30 Apr 1996
- Approved indications
- For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.
- Product number
- EMEA/H/C/000088
- Authorisation holder
- Eli Lilly Nederland B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 2
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Diabetes Mellitus
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Insulin receptor agonist
- Action type
- Agonist
- Target
- Insulin receptor
- Protein identifier
- P06213
Open Targets mechanisms
- Mechanism
- Insulin receptor agonist
- Action type
- Agonist
- Target
- Insulin receptor
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Hyperglycemia
- Highest recorded phase
- 3
- Condition identifier
- HP:0003074
- Subject identifier
- D006943
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition
- Diabetes Mellitus, Type 2
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0005148
- Subject identifier
- D003924
- Condition identifier
- EFO_0000400
- Condition identifier
- EFO_1000653
- Condition identifier
- GO_0006006
- Highest recorded phase
- 1
- Condition identifier
- HP_0001943
- Highest recorded phase
- 3
- Condition identifier
- HP_0003074
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004975
- Condition identifier
- MONDO_0005015
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005147
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005148
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005300
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005406
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005468
- Condition identifier
- MONDO_0006920
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0010030
- Highest recorded phase
- 3
- Event
- anti-insulin antibody positive
- Reports
- 36
- Reporting signal score
- 141.877
- Event
- blindness
- Reports
- 134
- Reporting signal score
- 143.459
- Event
- blood glucose abnormal
- Reports
- 236
- Reporting signal score
- 632.013
- Event
- blood glucose decreased
- Reports
- 583
- Reporting signal score
- 1,690.27
- Event
- blood glucose fluctuation
- Reports
- 154
- Reporting signal score
- 427.248
- Event
- blood glucose increased
- Reports
- 2,265
- Reporting signal score
- 6,686.35
- Event
- diabetes mellitus inadequate control
- Reports
- 311
- Reporting signal score
- 770.892
- Event
- diabetic ketoacidosis
- Reports
- 474
- Reporting signal score
- 1,007.36
- Event
- diabetic neuropathy
- Reports
- 81
- Reporting signal score
- 208.914
- Event
- diabetic retinopathy
- Reports
- 110
- Reporting signal score
- 344.595
- Event
- glycosylated haemoglobin increased
- Reports
- 318
- Reporting signal score
- 777.996
- Event
- hyperglycaemia
- Reports
- 432
- Reporting signal score
- 815.6
- Event
- hypoglycaemia
- Reports
- 1,810
- Reporting signal score
- 5,359.15
- Event
- hypoglycaemia neonatal
- Reports
- 95
- Reporting signal score
- 294.55
- Event
- hypoglycaemia unawareness
- Reports
- 24
- Reporting signal score
- 102.035
- Event
- hypoglycaemic coma
- Reports
- 173
- Reporting signal score
- 542.975
- Event
- hypoglycaemic seizure
- Reports
- 55
- Reporting signal score
- 188.682
- Event
- hypoglycaemic unconsciousness
- Reports
- 124
- Reporting signal score
- 477.371
- Event
- infusion site pain
- Reports
- 63
- Reporting signal score
- 118.891
- Event
- insulin resistance
- Reports
- 50
- Reporting signal score
- 154.847
- Event
- intercepted product selection error
- Reports
- 31
- Reporting signal score
- 126.06
- Event
- ketoacidosis
- Reports
- 97
- Reporting signal score
- 190.717
- Event
- low birth weight baby
- Reports
- 97
- Reporting signal score
- 161.863
- Event
- pharmaceutical product complaint
- Reports
- 123
- Reporting signal score
- 148.965
- Event
- premature baby
- Reports
- 339
- Reporting signal score
- 551.463
And 4 more, listed on the interactive page.
- NCT00046501
- NCT00071448
- NCT00348374
- NCT00467376
- NCT00705536
- NCT00862849
- NCT01000922
- NCT01067118
- NCT01235039
- NCT01908894
- NCT02221323
- NCT02324309
- NCT04235439
- NCT00097071
- NCT00115570
- NCT00191581
- NCT00487240
- NCT00553488
- NCT00652288
- NCT00700622
- NCT00747006
- NCT00774800
- NCT00883558
- NCT00993473
- NCT01035801
And 102 more, listed on the interactive page.
- Dose
- Unit dose (U-100 or U-200)
- Route
- Subcutaneous
- How often
- At the start of a meal or within 20 minutes after starting a meal
- Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis
- Rotate injection sites within the same region
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- FVNQHLCGSHLVEALYLVCGERGFFYTKPT
- Component
- Light chain
- Type
- Protein
- Sequence
- GIVEQCCTSICSLYQLENYCN
- 0002-0800
- 0002-7510
- 0002-7511
- 0002-7516
- 0002-7712
- 0002-7714
- 0002-7726
- 0002-7728
- 0002-7737
- 0002-7752
- 0002-8207
- 0002-8213
- 0002-8222
- 0002-8228
- 0002-8233
- 0002-8235
- 0002-8351
- 0002-8797
- 0002-8798
- 0002-8799
- 0024-5924
- 0024-5925
- 0024-5926
- 50090-1375
- 50090-1663
And 5 more, listed on the interactive page.
Related records
Trials (262)
- 21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus
- 24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine
- 6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes
- A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
- A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
- A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers
- A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
- A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
- A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
- A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
- A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
- A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
- A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
- A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
- A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
- A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
- A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial
- A Randomized Control Trial Comparing Linjeta Versus Humalog in Pumps: Effect on Postprandial Blood Sugars.
- A Single Bolus, 12-hour Euglycemic Clamp Study of the Safety, Pharmacokinetics (PK) and Glucodynamics (GD) of Intraperitoneal (IP) Portal Insulin U-500
- A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)
Approved for (1)
In development for (3)
- Hyperglycemia Phase 3
- Type 1 diabetes mellitus Phase 3
- Type 2 diabetes mellitus Phase 3
Targets (1)
- INSR Insulin receptor agonist