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 |
|---|---|---|
| afrezza | Biologic Licensing Application | 2023-02-27 |
| exubera | 2008-04-08 | |
| humalog 70/30 | New Drug Application | 2010-11-05 |
| humulin | Biologic Licensing Application | 2025-05-27 |
| humulin humulin 70/30 | New Drug Application | 2013-12-18 |
| humulin humulin n | New Drug Application | 2013-12-18 |
| humulin humulin n sterile diluent | New Drug Application | 2013-11-14 |
| humulin sterile diluent | Biologic Licensing Application | 2023-03-07 |
| humulin 70/30 | 2009-03-30 | |
| humulin humulin | Biologic Licensing Application | 2024-12-10 |
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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
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HCPCS
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Clinical
Clinical Trials
7696 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 2 | 2 | 1 | 1 | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parenteral nutrition | D010288 | — | — | — | 1 | 1 | — | — | 1 |
| Critical illness | D016638 | — | — | — | — | 1 | — | — | 1 |
| Hyperglycemia | D006943 | — | R73.9 | — | — | 1 | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | 1 | 1 | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 1 | 1 | — | — | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 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
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Financial
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Humulin – Eli Lilly
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Estimated US medical usage
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Trends
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Safety
Black-box Warning
Black-box warning for: Afrezza
Adverse Events
Top Adverse Reactions
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240,751 adverse events reported
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