Humulin r u-100, Insuman(insulin human)
Afrezza, Humulin, Insuman, Myxredlin, Novolin (insulin human) is a protein pharmaceutical. Insulin human was first approved as Humulin r u-100 on 1982-10-28. It has been approved in Europe to treat diabetes mellitus.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Afrezza, Humulin u, Myxredlin, Novolin (discontinued: Humulin u)
CombinationsHumulin, Novolin
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 human
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Humulin R U-500 | insulin human | Eli Lilly | N-18780 RX | 1994-03-31 | 2 products |
| Humulin R U-100 | insulin human | Eli Lilly | N-18780 OTC | 1982-10-28 | 2 products |
| Afrezza | insulin human | Mannkind Corporation | N-22472 RX | 2014-06-27 | 3 products |
| Novolin R | insulin human | Novo Nordisk | N-19938 OTC | 1991-06-25 | 2 products |
Show 1 discontinued
Insulin human
+
Insulin isophane human
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Humulin 70/30 | insulin isophane human and insulin human | Eli Lilly | N-19717 OTC | 1989-04-25 | 3 products |
| Novolin 70/30 | insulin isophane human and insulin human | Novo Nordisk | N-19991 OTC | 1991-06-25 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| .insulin aspart protamine and insulin aspart | Biologic Licensing Application | 2024-02-22 |
| .insulin aspart protamine and insulin aspart insulin aspart protamine and insulin aspart | Biologic Licensing Application | 2019-11-15 |
| admelog | Biologic Licensing Application | 2025-02-06 |
| afrezza | Biologic Licensing Application | 2023-02-27 |
| apidra | 2008-11-06 | |
| apidra apidra solostar | Biologic Licensing Application | 2023-07-25 |
| basaglar | New Drug Application | 2019-01-28 |
| basaglar basaglar | Biologic Licensing Application | 2023-11-29 |
| exubera | 2008-04-08 | |
| fiasp | Biologic Licensing Application | 2023-06-21 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
7562 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 27 | 8 | 72 | 83 | 19 | 208 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 7 | 3 | 53 | 80 | 15 | 158 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 19 | 5 | 23 | 16 | 5 | 67 |
| Hyperglycemia | D006943 | — | R73.9 | 1 | — | 1 | 7 | 5 | 14 |
| Hypoglycemia | D007003 | — | E16.2 | — | — | — | 3 | 2 | 5 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 3 | — | 3 |
| Fibrosis | D005355 | — | — | — | — | 1 | 1 | — | 2 |
| Lipodystrophy | D008060 | — | E88.1 | — | — | — | 1 | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | — | 1 |
| Ketosis | D007662 | — | R82.4 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | — | — | 1 | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | 1 | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 1 | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | 1 | — | — | 1 |
| Hypercholesterolemia | D006937 | — | — | — | — | 1 | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 1 | — | — | 1 |
| Overweight | D050177 | — | E66.3 | — | — | 1 | — | — | 1 |
| Weight loss | D015431 | — | — | — | — | 1 | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 1 | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Gestational diabetes | D016640 | — | O24.4 | — | 1 | — | — | — | 1 |
| Pregnancy in diabetics | D011254 | — | O24.91 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 1 | 1 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 1 | 1 |
| Emergencies | D004630 | — | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Patient participation | D010358 | — | — | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 1 | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Insulin human |
| INN | insulin icodec |
| Description | Recombinant human insulin |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
Target
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Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
Black-box warning for: Afrezza, Xultophy 100/3.6
Adverse Events
Top Adverse Reactions
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234,128 adverse events reported
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