Humalog(insulin lispro)
Admelog, Humalog, Insulin Lispro, Liprolog, Liumjev, Lyumjev (insulin lispro) is a protein pharmaceutical. Insulin lispro was first approved as Humalog on 1996-04-30. It is used to treat hyperglycemia, type 1 diabetes mellitus, and type 2 diabetes mellitus in the USA. It has been approved in Europe to treat diabetes mellitus.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Admelog, Humalog, Lyumjev (discontinued: Humalog, Lyumjev)
CombinationsHumalog mix (discontinued: Humalog mix)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Insulin lispro
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Humalog | insulin lispro | Eli Lilly | N-20563 RX | 1996-06-14 | 5 products |
| Humalog | insulin lispro | Eli Lilly | N-205747 RX | 2015-05-26 | 2 products |
| Lyumjev | insulin lispro-aabc | Eli Lilly | N-761109 RX | 2020-06-15 | 4 products |
| Admelog | insulin lispro | Sanofi | N-209196 RX | 2017-12-11 | 3 products |
Show 2 discontinued
Insulin lispro
+
Insulin lispro protamine
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| admelog | Biologic Licensing Application | 2025-10-01 |
| humalog | Biologic Licensing Application | 2025-04-01 |
| humalog 70/30 | New Drug Application | 2010-11-05 |
| humalog humalogpen | New Drug Application | 2011-12-20 |
| humalog mix50/50 | 2007-09-25 | |
| humalog mix75/25 | 2009-03-30 | |
| humalog mix75/25 humalog mix75/25 kwikpen humalog mix75/25 pen | New Drug Application | 2009-03-16 |
| humalog sterile diluent | Biologic Licensing Application | 2025-06-17 |
| insulin lispro | Biologic Licensing Application | 2024-05-31 |
| insulin lispro insulin lispro | Biologic Licensing Application | 2024-08-06 |
Show 3 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
| type 1 diabetes mellitus | EFO_0001359 | D003922 | E10 |
| hyperglycemia | — | D006943 | R73.9 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10A: Insulins and analogues
— A10AB: Insulins and analogues for injection, fast-acting
— A10AB04: Insulin lispro
— A10AC: Insulins and analogues for injection, intermediate-acting
— A10AC04: Insulin lispro
— A10AD: Insulins and analogues for injection used in diabetes, intermediate- or long-acting combined with fast-acting
— A10AD04: Insulin lispro
HCPCS
No data
Clinical
Clinical Trials
374 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 54 | 39 | 36 | 26 | 38 | 184 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 25 | 21 | 28 | 38 | 23 | 126 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 19 | 8 | 29 | 45 | 12 | 111 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 10 | 14 | 6 | 10 | 8 | 46 |
| Healthy volunteers/patients | — | — | — | 22 | 1 | — | 1 | 1 | 25 |
| Hyperglycemia | D006943 | — | R73.9 | 3 | 2 | 4 | 9 | 2 | 18 |
| Hypoglycemia | D007003 | — | E16.2 | 2 | 8 | — | 1 | 1 | 12 |
| Gestational diabetes | D016640 | — | O24.4 | — | 3 | — | 3 | 4 | 10 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | 1 | — | 1 | 1 | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | 3 | — | 3 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 3 | 1 | — | 1 | 4 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | 1 | — | 1 | 2 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | 1 | 1 | — | — | 1 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 1 | 1 | — | — | 1 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | — | 1 | — | — | 1 |
| Ischemic stroke | D000083242 | — | — | — | 1 | 1 | — | — | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 1 | — | — | 1 |
| Vascular dementia | D015140 | — | F01 | — | 1 | 1 | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | 1 | — | — | 1 |
| Pancreatectomy | D010180 | EFO_0002581 | — | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Motor activity | D009043 | EFO_0003940 | — | 1 | 1 | — | — | 1 | 3 |
| Glucose metabolism disorders | D044882 | — | — | — | 1 | — | — | 1 | 2 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | 1 | — | — | 1 | 2 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | 1 | 2 |
| Pregnancy in diabetics | D011254 | — | O24.91 | — | 1 | — | — | 1 | 2 |
| Diet therapy | D004035 | — | — | — | 1 | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | — | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | 1 | — | — | — | 1 |
| Therapeutics | D013812 | — | — | — | 1 | — | — | — | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | 1 | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes complications | D048909 | — | — | — | — | — | — | 2 | 2 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 2 | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 1 | 1 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 1 | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | — | — | — | — | 1 | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 1 | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Insulin lispro |
| INN | insulin lispro |
| Description | Insulin lispro recombinant |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 5UDP, 6NWV |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201538 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00046 |
| UNII ID | GFX7QIS1II (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Humalog – Eli Lilly
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Estimated US medical usage
Insulin lispro
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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94,791 adverse events reported
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