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 |
Show 8 more
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
7766 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 | 327 | 314 | 444 | 345 | 1518 | 2856 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 169 | 204 | 425 | 437 | 1003 | 2188 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 257 | 248 | 214 | 149 | 945 | 1747 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 132 | 204 | 111 | 196 | 1031 | 1629 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 50 | 72 | 36 | 33 | 523 | 693 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 19 | 58 | 20 | 28 | 225 | 333 |
| Hypoglycemia | D007003 | — | E16.2 | 32 | 51 | 23 | 21 | 168 | 282 |
| Hyperglycemia | D006943 | — | R73.9 | 21 | 25 | 26 | 51 | 140 | 255 |
| Healthy volunteers/patients | — | — | — | 127 | 8 | 5 | 10 | 95 | 243 |
| Syndrome | D013577 | — | — | 13 | 37 | 15 | 15 | 149 | 218 |
Show 218 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 9 | 11 | 1 | — | 22 | 39 |
| Neoplasms | D009369 | — | C80 | 9 | 6 | 1 | — | 18 | 33 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 4 | 17 | 1 | — | 14 | 33 |
| Diabetes complications | D048909 | — | — | — | 6 | 8 | — | 15 | 23 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 2 | 3 | — | 18 | 23 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 8 | 2 | — | 8 | 19 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | 14 | 16 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | 2 | 3 | 2 | — | 8 | 14 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | 3 | 2 | — | 8 | 13 |
| Dementia | D003704 | EFO_0003862 | F03 | 2 | 8 | 1 | — | 4 | 13 |
Show 120 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exercise | D015444 | EFO_0000483 | — | — | 1 | — | — | 23 | 24 |
| Hyperandrogenism | D017588 | — | — | 1 | 7 | — | — | 6 | 13 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 3 | — | — | 10 | 13 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 3 | 4 | — | — | 4 | 10 |
| Metabolism | D008660 | GO_0008152 | — | — | 2 | — | — | 7 | 9 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | — | 8 | 9 |
| Feeding behavior | D005247 | — | — | — | 1 | — | — | 8 | 9 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 6 | — | — | 3 | 9 |
| Nutritional and metabolic diseases | D009750 | — | — | — | 1 | — | — | 8 | 9 |
| Muscular atrophy | D009133 | — | — | 1 | 2 | — | — | 5 | 8 |
Show 166 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | 2 | — | — | — | 17 | 19 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | — | — | — | 7 | 8 |
| Gastric bypass | D015390 | EFO_0005244 | — | 3 | — | — | — | 4 | 7 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 3 | — | — | — | 3 | 6 |
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | 1 | — | — | — | 4 | 5 |
| Hepatitis b | D006509 | — | — | 1 | — | — | — | 3 | 4 |
| Eczema | D004485 | — | L30.9 | 1 | — | — | — | 3 | 4 |
| Pancreas transplantation | D016035 | — | — | 1 | — | — | — | 3 | 4 |
| Melanosis | D008548 | EFO_0003963 | L81.1 | 2 | — | — | — | 2 | 4 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | 1 | — | — | — | 2 | 3 |
Show 54 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood glucose self-monitoring | D015190 | — | — | — | — | — | — | 13 | 13 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 11 | 11 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 10 | 10 |
| Body composition | D001823 | — | — | — | — | — | — | 10 | 10 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 9 | 9 |
| Healthy diet | D000072001 | — | — | — | — | — | — | 9 | 9 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | — | — | 9 | 9 |
| Surgical wound infection | D013530 | — | — | — | — | — | — | 9 | 9 |
| Satiety response | D012528 | — | — | — | — | — | — | 8 | 8 |
| Lipid metabolism | D050356 | — | — | — | — | — | — | 7 | 7 |
Show 433 more
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) | — |
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Humulin – Eli Lilly
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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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