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
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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
7763 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 | 3 | 9 | 8 | 4 | 5 | 28 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 8 | 10 | 3 | 3 | 24 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 3 | 4 | 7 | 4 | 4 | 22 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 2 | — | 1 | 1 | 1 | 5 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | 1 | 3 | — | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | 2 | — | — | 3 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | 1 | — | — | 2 |
| Glucose metabolism disorders | D044882 | — | — | — | 1 | 1 | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | 1 | 1 | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | 1 | — | — | 1 |
| Pregnancy complications | D011248 | — | — | — | 1 | 1 | — | — | 1 |
| Gestational diabetes | D016640 | — | O24.4 | — | 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 | — | — | — | 7 | — | — | — | — | 7 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | — | 1 |
| Obstructive lung diseases | D008173 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Motor activity | D009043 | EFO_0003940 | — | — | — | — | — | 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
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Variants
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Humulin – Eli Lilly
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Estimated US medical usage
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Safety
Black-box Warning
Black-box warning for: Afrezza
Adverse Events
Top Adverse Reactions
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39,795 adverse events reported
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