Humatrope, Nutropinaq(somatropin pegol)
Genotropin, Humatrope, Norditropin, Nutropin, NutropinAq, Omnitrope, Saizen, Serostim, Zomacton (somatropin pegol) is a protein pharmaceutical. Somatropin pegol was first approved as Humatrope on 1986-10-16. It has been approved in Europe to treat growth, pituitary dwarfism, prader-willi syndrome, and turner syndrome.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| musculoskeletal diseases | D009140 |
| nervous system diseases | D009422 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
| physiological phenomena | D010829 |
Trade Name
FDA
EMA
Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, Zomacton (discontinued: Accretropin, Zorbtive/serostim)
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)
Somatropin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Nutropin AQ | somatropin | Genentech, Inc. | N-20522 RX | 2008-01-03 | 3 products |
| Saizen | somatropin | EMD Serono | N-19764 RX | 1996-10-08 | 2 products |
| Serostim | somatropin | EMD Serono | N-20604 RX | 1996-08-23 | 3 products |
| Humatrope | somatropin | Eli Lilly | N-19640 RX | 1986-10-16 | 4 products |
| Zomacton | somatropin | Ferring Pharmaceuticals Inc. | N-19774 RX | 1995-05-25 | 3 products |
| Norditropin | somatropin | Novo Nordisk Inc. | N-21148 RX | 2010-03-01 | 4 products |
| Genotropin | somatropin | Pharmacia & Upjohn Company LLC | N-20280 RX | 1995-08-24 | 12 products |
| Omnitrope | somatropin | Sandoz Inc. | N-21426 RX | 2006-05-30 | 3 products |
Show 10 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| genotropin | Biologic Licensing Application | 2023-04-26 |
| humatrope | Biologic Licensing Application | 2022-07-12 |
| norditropin | Biologic Licensing Application | 2020-03-09 |
| nutropin aq nuspin 10 nutropin aq nuspin 20 nutropin aq nuspin 5 | Biologic Licensing Application | 2021-12-13 |
| omnitrope | Biologic Licensing Application | 2019-06-18 |
| saizen saizenprep | Biologic Licensing Application | 2022-02-02 |
| serostim | Biologic Licensing Application | 2022-02-02 |
| zomacton | Biologic Licensing Application | 2023-01-17 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
somatropin, Norditropin, Novo Nordisk Inc. | |||
| 2114-05-31 | Orphan excl. | ||
somatropin, Humatrope, Eli Lilly and Company | |||
| 2113-11-01 | Orphan excl. | ||
somatropin, Genotropin, Pharmacia & Upjohn Company LLC | |||
| 2108-07-25 | Orphan excl. | ||
somatropin, Nutropin, Genentech, Inc. | |||
| 2103-12-30 | Orphan excl. | ||
somatropin, Serostim, EMD Serono, Inc. | |||
| 2103-08-23 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
411 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | 9 | 23 | 37 | 23 | 35 | 126 |
| Turner syndrome | D014424 | Orphanet_881 | Q96 | 1 | 4 | 7 | 6 | 10 | 28 |
| Healthy volunteers/patients | — | 12 | — | — | 3 | 3 | 18 | ||
| Inborn genetic diseases | D030342 | EFO_0000508 | 1 | — | 5 | 3 | 8 | 17 | |
| Infertility | D007246 | EFO_0000545 | 2 | 4 | 2 | 4 | 2 | 12 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 3 | 3 | 2 | 4 | 12 |
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | 1 | — | 5 | 2 | 3 | 11 |
| Chronic renal insufficiency | D051436 | N18 | 1 | 1 | 2 | 4 | 2 | 10 | |
| Hypopituitarism | D007018 | EFO_0001380 | E23.0 | — | 3 | 2 | 3 | 3 | 10 |
| Pituitary dwarfism | D004393 | EFO_1001109 | E23.0 | — | 1 | 2 | 3 | 3 | 9 |
Show 19 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Growth disorders | D006130 | 4 | 1 | 7 | — | 4 | 16 | ||
| Noonan syndrome | D009634 | Orphanet_648 | Q87.19 | — | — | 4 | — | 3 | 7 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 3 | 2 | — | 2 | 7 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 5 | 2 | — | — | 7 |
| Pituitary diseases | D010900 | E23.7 | — | — | 4 | — | 1 | 5 | |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | 5 | — | — | 5 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 3 | 1 | — | 1 | 4 |
| Dwarfism | D004392 | E34.31 | — | 2 | 2 | — | — | 4 | |
| Cognitive dysfunction | D060825 | G31.84 | 1 | 1 | 1 | — | — | 3 | |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | 1 | — | 1 | 3 |
Show 29 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aging | D000375 | GO_0007568 | R41.81 | 1 | 3 | — | — | 1 | 4 |
| Insulin resistance | D007333 | EFO_0002614 | 1 | 1 | — | — | 2 | 3 | |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 1 | — | — | — | 2 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | 1 | 1 | — | — | 1 | 2 | |
| Chronic kidney disease-mineral and bone disorder | D012080 | EFO_1001152 | N25.0 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 1 | — | — | — | 1 |
| Gonadal dysgenesis | D006059 | — | 1 | — | — | — | 1 | ||
| Rupture | D012421 | — | 1 | — | — | — | 1 | ||
| Body weight changes | D001836 | 1 | 1 | — | — | — | 1 | ||
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | 1 | — | — | — | 1 |
Show 15 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Facioscapulohumeral muscular dystrophy | D020391 | EFO_0000491 | G71.02 | 1 | — | — | — | — | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | — | — | — | — | 1 |
| Hypophosphatemic rickets | D063730 | E83.31 | 1 | — | — | — | — | 1 | |
| Post-concussion syndrome | D038223 | EFO_1001827 | F07.81 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acromegaly | D000172 | — | — | — | — | 2 | 2 | ||
| Fatty liver | D005234 | — | — | — | — | 1 | 1 | ||
| Metabolism | D008660 | GO_0008152 | — | — | — | — | 1 | 1 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Ketosis | D007662 | HP_0002919 | R82.4 | — | — | — | — | 1 | 1 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 1 | 1 |
| Pituitary neoplasms | D010911 | — | — | — | — | 1 | 1 | ||
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
| Werner syndrome | D014898 | Orphanet_902 | E34.8 | — | — | — | — | 1 | 1 |
| Chromosome aberrations | D002869 | Orphanet_68335 | — | — | — | — | 1 | 1 |
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SOMATROPIN PEGOL |
| INN | somatropin pegol |
| Description | Genotropin, Humatrope, Norditropin, Nutropin, NutropinAq, Omnitrope, Saizen, Serostim, Zomacton (somatropin pegol) is a protein pharmaceutical. Somatropin pegol was first approved as Humatrope on 1986-10-16. It has been approved in Europe to treat growth, pituitary dwarfism, prader-willi syndrome, and turner syndrome. |
| Classification | Protein |
| Drug class | PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer; tricyclic compounds; growth hormone derivatives; atropine derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108315 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | ZF7544FTQW (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
No data
Financial
Genotropin - Pfizer
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Trends
PubMed Central
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Additional graphs summarizing 929 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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38,445 adverse events reported
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